{ "$schema": "https://www.conphora.com/schemas/regulation-page.json", "code": "IVDR", "locale": "en", "url": "https://www.conphora.com/regulations/ivdr/", "json": "https://www.conphora.com/regulations/ivdr.json", "summaryPdf": "https://www.conphora.com/regulations/ivdr/summary.pdf", "dateModified": "2026-09-12", "regulation": { "code": "IVDR", "name": "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU", "shortName": "In Vitro Diagnostic Medical Devices Regulation", "reference": "Regulation (EU) 2017/746", "celex": "32017R0746", "eurlex": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746", "actType": "Regulation", "category": "Medical Devices", "inForce": "2017-05-25", "appliesFrom": "2022-05-26", "changing": true, "video": "regulation-ivdr" }, "answer": "The In Vitro Diagnostic Medical Devices Regulation governs in vitro diagnostic devices on the EU market, from classification in classes A to D to notified-body assessment, CE marking and Eudamed, for manufacturers, importers and distributors. It has applied since 26 May 2022; directive-covered devices may stay on the market until 31 December 2027, 2028 or 2029 under Regulation (EU) 2024/1860.", "description": "IVDR guide: the In Vitro Diagnostic Medical Devices Regulation, what counts as an IVD, classes A to D and the conformity routes, performance evaluation, UDI and Eudamed, vigilance, the legacy-device transition to 2027, 2028 and 2029, and what manufacturers, importers and distributors must do.", "enforcedBy": "National competent authorities for in vitro diagnostic medical devices carry out the market surveillance under Chapter VII of the regulation; in Denmark that is Lægemiddelstyrelsen (the Danish Medicines Agency), which supervises manufacturers and the other economic operators, receives incident and supply-interruption reports, verifies the Eudamed actor registrations that lead to a single registration number and registers Danish distributors and specialist retailers of IVDs, under lov om medicinsk udstyr, lovbekendtgørelse nr. 682 af 29. maj 2023, as amended by lov nr. 1759 of 29 December 2025, and bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (in force 1 January 2026, repealing bekendtgørelse nr. 837 af 20. juni 2023 om medicinsk udstyr m.v., the previous executive order on medical devices, under its § 21, stk. 2). In Denmark, executive order nr. 1731 of 8 December 2025 makes the manufacturer report serious incidents covered by Article 82(1), point (a), to Lægemiddelstyrelsen where the incident occurred in Denmark, send the agency the final investigation report under Article 84(5) and send it every field safety corrective action notice under Article 82(1), point (b); the operators of public and private hospitals must report immediately any incident with a device or IVD that has caused or could cause death or a serious deterioration in health (sections 8 to 11). The toolkit is documentation and sample requests, announced and unannounced inspections, corrective action within a set period, restriction or prohibition of the making available, withdrawal, recall, confiscation or destruction of devices presenting an unacceptable risk or falsified devices, measures against formal non-compliance, and national penalties that must be effective, proportionate and dissuasive.", "keyDates": [ { "date": "2017-04-05", "label": "Regulation (EU) 2017/746 adopted by the European Parliament and the Council in Strasbourg; published in OJ L 117 on 5 May 2017", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746 · title and signature block after Art. 113" }, { "date": "2017-05-25", "label": "Entry into force, the twentieth day after publication in the Official Journal", "source": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32017R0746 · Art. 113(1)" }, { "date": "2017-11-26", "label": "Articles 31 to 46 on notified bodies and Article 96 on competent authorities apply, so that bodies could be designated under the regulation before the date of application", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (b)" }, { "date": "2018-05-26", "label": "Article 97 on cooperation between Member States applies", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (c)" }, { "date": "2019-05-26", "label": "GS1, HIBCC and ICCBBA are deemed designated UDI issuing entities until the Commission designates entities under Article 24(2)", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(10) and Art. 113(3), point (h)" }, { "date": "2020-11-25", "label": "Article 100 on the EU reference laboratories for class D devices applies", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (d)" }, { "date": "2022-01-28", "label": "Regulation (EU) 2022/112 in force on the day of publication: transitional periods staggered by risk class for devices that need a notified body for the first time, sell-off dates extended, and the Article 5(5) conditions for in-house devices deferred to 26 May 2024 and 26 May 2028", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0112 · Art. 1 and Art. 2" }, { "date": "2022-05-26", "label": "The regulation applies; Directive 98/79/EC is repealed subject to the transitional provisions and notifications of notified bodies under it become void", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(1), Art. 112 and Art. 113(2)" }, { "date": "2023-03-11", "label": "Delegated Regulation (EU) 2023/503 in force: complete re-assessment of notified bodies every 5 years instead of 3 years after notification and every 4 years thereafter", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0503 · Art. 1 and Art. 2" }, { "date": "2023-03-20", "label": "Regulation (EU) 2023/607 in force on the day of publication: devices lawfully placed on the market under Directive 98/79/EC or under the transitional provisions may continue to be made available without a sell-off deadline", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607 · Art. 2 and Art. 3" }, { "date": "2023-05-26", "label": "UDI carrier required on the label and all higher packaging levels of class D devices", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 24(4) and Art. 113(3), point (e)" }, { "date": "2024-05-26", "label": "Article 5(5), points (b), (c) and (e) to (i), apply to in-house devices: quality management system, EN ISO 15189 laboratory, information to the competent authority, public declaration, class D documentation, manufacture to the documentation and review of clinical experience", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(5) and Art. 113(3), point (i)" }, { "date": "2024-07-09", "label": "Regulation (EU) 2024/1860 in force on the day of publication: transition extended to 31 December 2027, 2028 and 2029 by class with conditions, gradual roll-out of Eudamed module by module, new Article 10a on supply interruptions, Article 5(5), point (d), deferred to 31 December 2030", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 2 and Art. 3" }, { "date": "2025-01-10", "label": "Article 10a applies: manufacturers must give at least 6 months' notice of an anticipated interruption or discontinuation of supply that could cause serious harm", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 2, point (1), and Art. 3" }, { "date": "2025-05-26", "label": "UDI carrier required on the labels of class B and class C devices; deadline for legacy-device manufacturers to have a quality management system under Article 10(8), and for class D and certificate devices to have lodged a formal application with a notified body", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (e), and Art. 110(3c), points (d) and (e)(i)" }, { "date": "2025-05-27", "label": "Certificates issued under Annex VI to Directive 98/79/EC (EC verification) become void at the latest", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(2), first subparagraph" }, { "date": "2025-09-26", "label": "Deadline for the written agreement between the manufacturer and a notified body for class D and certificate legacy devices; from this date that notified body is responsible for their surveillance", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3c), point (f)(i), and Art. 110(3e)" }, { "date": "2025-11-27", "label": "Commission Decision (EU) 2025/2371 published: the Eudamed modules for actors, UDI and devices, notified bodies and certificates, and market surveillance are confirmed functional, starting the 6-month clock of Article 113(3), point (f)", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1 and Art. 2; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (f)" }, { "date": "2026-05-26", "label": "Deadline for class C legacy devices to have a formal application lodged with a notified body", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3c), point (e)(ii)" }, { "date": "2026-05-28", "label": "Mandatory use of the first four Eudamed modules (actor registration, UDI and device registration, notified bodies and certificates, market surveillance); manufacturers, authorised representatives and importers register in Eudamed instead of national databases — the Commission gives 28 May 2026; Article 113(3), point (f), counts six months from the publication of the notice on 27 November 2025, so plan for 27 May 2026", "source": "https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (f); https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/" }, { "date": "2026-09-26", "label": "Deadline for the written agreement between the manufacturer and a notified body for class C legacy devices", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3c), point (f)(ii)" }, { "date": "2026-11-28", "label": "Deadline (6 months after the Eudamed date of 28 May 2026) for manufacturers to have entered in Eudamed the Article 26 information on devices placed on the market from 28 May 2026, including legacy devices under Article 110(3), (3a) and (3b) (27 November 2026 on a strict count from the notice)", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (fa); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 2" }, { "date": "2027-05-26", "label": "UDI carrier required on the labels of class A devices; deadline for class B and sterile class A legacy devices to have a formal application lodged with a notified body", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (e), and Art. 110(3c), point (e)(iii)" }, { "date": "2027-05-27", "label": "Deadline for the Commission's evaluation report on the application of the regulation, with special attention to UDI storage and traceability and to Article 4", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 111" }, { "date": "2027-05-28", "label": "Deadline (12 months after the Eudamed date) for notified bodies to have entered their certificates in Eudamed; the duties to upload the summary of safety and performance and to notify certificates follow the certificate entry (27 May 2027 on a strict count from the notice)", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), points (fb) and (fc)" }, { "date": "2027-09-26", "label": "Deadline for the written agreement between the manufacturer and a notified body for class B and sterile class A legacy devices", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3c), point (f)(iii)" }, { "date": "2027-12-31", "label": "End of the transitional period for class D legacy devices and for every device covered by a directive certificate; directive certificates issued from 25 May 2017 that were valid on 26 May 2022 expire at the latest", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(2), second subparagraph, Art. 110(3a) and Art. 110(3b), point (a)" }, { "date": "2028-12-31", "label": "End of the transitional period for class C legacy devices", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3b), point (b)" }, { "date": "2029-12-31", "label": "End of the transitional period for class B legacy devices and class A devices placed on the market in sterile condition", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3b), point (c)" }, { "date": "2030-12-31", "label": "Article 5(5), point (d), applies: health institutions must document that no equivalent CE-marked device on the market meets the target patient group's needs before making an in-house device", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (j)" } ], "amendedBy": [ { "reference": "Regulation (EU) 2022/112", "celex": "32022R0112", "date": "2022-01-28", "summary": "The COVID-19 transitional regulation of 25 January 2022 kept the date of application of 26 May 2022 but rewrote Article 110(2) to (4): directive certificates got until 27 May 2025 instead of 27 May 2024, devices with a valid directive certificate could be placed on the market until 26 May 2025, and devices that needed a notified body for the first time got staggered dates of 26 May 2025 (class D), 26 May 2026 (class C) and 26 May 2027 (class B and sterile class A), with sell-off dates one year later; the Article 5(5) conditions for in-house devices were deferred to 26 May 2024, and the condition on the absence of an equivalent device on the market to 26 May 2028.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0112 · Art. 1 and Art. 2" }, { "reference": "Commission Delegated Regulation (EU) 2023/503", "celex": "32023R0503", "date": "2023-03-11", "summary": "The delegated regulation of 1 December 2022 replaced Article 40(10): the complete re-assessment of a notified body takes place 5 years after notification and every 5 years thereafter, with earlier re-assessment on request or where the annual assessments raise concerns, so that authorities and notified bodies can concentrate on certification during the transitional period.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0503 · Art. 1 and Art. 2" }, { "reference": "Regulation (EU) 2023/607", "celex": "32023R0607", "date": "2023-03-20", "summary": "The transitional-provisions regulation of 15 March 2023, adopted mainly for the MDR, replaced Article 110(4) of the IVDR so that devices lawfully placed on the market under Directive 98/79/EC before 26 May 2022, or under the transitional provisions after that date, may continue to be made available or put into service without a sell-off deadline, and aligned the second paragraph of Article 112 on the continued application of the directive to those devices.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607 · Art. 2 and Art. 3" }, { "reference": "Regulation (EU) 2024/1860", "celex": "32024R1860", "date": "2024-07-09", "summary": "The regulation of 13 June 2024 inserted Article 10a (at least 6 months' notice of an anticipated interruption or discontinuation of supply that could cause serious harm, applicable from 10 January 2025 and also to legacy devices), rewrote Article 110(2) and (3) so that directive certificates valid on 26 May 2022 remain valid until 31 December 2027 and legacy devices may be placed on the market until 31 December 2027 (class D and certificate devices), 31 December 2028 (class C) or 31 December 2029 (class B and sterile class A) subject to a quality management system by 26 May 2025, staggered notified-body application and written-agreement deadlines and continued directive compliance, allowed Eudamed to be rolled out module by module with the obligations for each module applying 6 months after the Commission notice on its functionality, set 6- and 12-month deadlines for entering existing devices and certificates, adapted the coordinated assessment of performance studies in Article 74(14), deleted Article 110(8) and Article 113(3), points (a) and (g), and deferred Article 5(5), point (d), to 31 December 2030.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 2 and Art. 3" } ], "scope": { "appliesTo": [ "In vitro diagnostic medical devices for human use: any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, including blood and tissue donations, to provide information on a physiological or pathological process or state, congenital impairments, predisposition to a condition or disease, safety and compatibility with potential recipients, treatment response, or to define or monitor therapeutic measures", "Specimen receptacles, which are deemed IVDs, and accessories for IVDs", "Devices for self-testing used by lay persons, devices for near-patient testing, companion diagnostics and software that is an IVD in its own right", "Devices placed on the market, made available or put into service in the Union, including devices offered online to persons in the Union and devices used to provide a diagnostic service at a distance, and performance studies conducted in the Union", "The economic operators: manufacturers, authorised representatives, importers and distributors" ], "derived": [ "Software that drives or influences a device takes that device's class; independent software is classified in its own right, and calibrators and control materials with assigned values take the class of the device they are used with (Annex VIII, Sections 1.4 to 1.6)", "A distributor, importer or other person that sells a device under its own name or trade mark, changes its intended purpose or modifies it in a way that may affect compliance takes on the manufacturer's obligations (Art. 16(1))", "A device that incorporates a medical device as an integral part is governed by the MDR, with the IVDR applying to the IVD part; the regulation is specific legislation for the purposes of the EMC Directive 2014/30/EU, and devices that are also machinery must additionally meet the more specific essential requirements of Directive 2006/42/EC (Art. 1(4) to (6)): Directive 2006/42/EC is repealed with effect from 20 January 2027 by Regulation (EU) 2023/1230 on machinery, from when that reference is read as a reference to the machinery regulation and its Annex III health and safety requirements", "Products for general laboratory use and research-use-only products are covered only where the manufacturer specifically intends them for in vitro diagnostic examination (Art. 1(3), point (a))", "Legacy devices placed on the market under Article 110(3a) or (3b) are already subject to the IVDR rules on post-market surveillance, market surveillance, vigilance and registration of operators and devices, and to the Article 10a supply-interruption notice (Art. 110(3d) and (11))", "Devices for performance studies follow Articles 57 to 77 instead of the conformity assessment procedures, carry no CE marking and are not counted as placed on the market (Art. 2, points (20) to (22), Art. 19(2) and Art. 48(11))" ], "categories": [ { "id": "class-a-device", "label": "Class A device that is not sterile: general laboratory reagents, buffers, washing solutions, culture media and stains for a specific examination, IVD instruments and analysers, specimen receptacles" }, { "id": "class-a-sterile-device", "label": "Class A device placed on the market in sterile condition" }, { "id": "class-b-device", "label": "Class B device: tests not caught by a higher rule, controls without an assigned value, pregnancy, fertility, cholesterol and urine glucose self-tests" }, { "id": "class-c-device", "label": "Class C device: tests for sexually transmitted or other infectious agents, cancer, human genetics, prenatal and newborn screening, companion diagnostics, most self-tests, blood grouping outside the ABO, Rhesus, Kell, Kidd and Duffy systems" }, { "id": "class-d-device", "label": "Class D device: tests for transmissible agents in blood, tissues and organs for transfusion or transplantation, life-threatening agents with a high risk of propagation, ABO, Rhesus, Kell, Kidd and Duffy blood grouping" }, { "id": "companion-diagnostic", "label": "Companion diagnostic essential for the safe and effective use of a medicinal product" }, { "id": "self-testing-device", "label": "Device for self-testing by lay persons or for near-patient testing outside a laboratory" }, { "id": "performance-study-device", "label": "Device for performance study used to establish or confirm analytical or clinical performance" }, { "id": "in-house-device", "label": "In-house device manufactured and used only within a health institution established in the Union" }, { "id": "legacy-device-98-79", "label": "Device placed on the market under Directive 98/79/EC with a directive certificate or a declaration of conformity drawn up before 26 May 2022" }, { "id": "research-use-only-product", "label": "Research-use-only product without an in vitro diagnostic intended purpose" }, { "id": "general-laboratory-product", "label": "Product for general laboratory use not specifically intended for in vitro diagnostic examination" }, { "id": "sampling-reference-or-eqa-product", "label": "Invasive sampling product applied to the body, internationally certified reference material, or material for external quality assessment schemes" }, { "id": "medical-device-mdr", "label": "Medical device that is not an IVD, or a device incorporating a medical device as an integral part" } ], "roles": [ { "id": "manufacturer", "label": "Manufacturer (including own-brand sellers and persons who change or modify a device)", "definition": "A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark; a distributor, importer or other person that makes a device available under its own name, changes its intended purpose or modifies it in a way that may affect compliance assumes the manufacturer's obligations.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 2, point (23), and Art. 16(1)" }, { "id": "other", "label": "Authorised representative", "definition": "Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union to act on the manufacturer's behalf in relation to specified tasks under the regulation; a non-EU manufacturer may place devices on the Union market only if it designates a sole authorised representative.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 2, point (25), and Art. 11(1)" }, { "id": "importer", "label": "Importer", "definition": "Any natural or legal person established within the Union that places a device from a third country on the Union market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 2, point (26)" }, { "id": "distributor", "label": "Distributor (wholesaler, pharmacy, laboratory supplier, retailer)", "definition": "Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 2, point (27)" } ], "rules": [ { "categories": [ "research-use-only-product", "general-laboratory-product" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "Products for general laboratory use and research-use-only products are excluded unless, in view of their characteristics, the manufacturer specifically intends them for in vitro diagnostic examination; a product labelled research-use-only but marketed or presented for diagnosing patients is an IVD and must be classified and CE-marked.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 1(3), point (a), and Art. 2, point (12)" }, { "categories": [ "sampling-reference-or-eqa-product" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "Invasive sampling products and products applied directly to the body to obtain a specimen (lancets, swabs, needles), internationally certified reference materials and materials for external quality assessment schemes are outside the regulation; invasive sampling products are medical devices under the MDR instead.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 1(3), points (b) to (d)" }, { "categories": [ "medical-device-mdr" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "A product without an in vitro examination purpose is not an IVD; a device that incorporates a medical device as an integral part is governed by Regulation (EU) 2017/745 (MDR), and only its IVD part must meet the requirements of this regulation.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 1(4) and Art. 2, points (1) and (2)" }, { "categories": [ "in-house-device" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Devices manufactured and used only within a health institution established in the Union are exempt from the regulation except the relevant general safety and performance requirements of Annex I, provided all nine conditions of Article 5(5) are met: no transfer to another legal entity, a quality management system, a laboratory compliant with EN ISO 15189 or national accreditation rules, a documented justification that no equivalent device on the market meets the need (from 31 December 2030), information to the competent authority on request, a public declaration, class D documentation, manufacture to that documentation and review of clinical experience; the exemption does not cover industrial-scale manufacture, and points (b), (c) and (e) to (i) apply since 26 May 2024.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(4) and (5) and Art. 113(3), points (i) and (j)" }, { "categories": [ "legacy-device-98-79" ], "roles": [ "manufacturer", "other", "importer", "distributor" ], "size": "any", "result": "depends", "note": "A device with a directive certificate valid on 26 May 2022 may be placed on the market until 31 December 2027; a device with a directive declaration of conformity drawn up before 26 May 2022 that now needs a notified body until 31 December 2027 (class D), 31 December 2028 (class C) or 31 December 2029 (class B and sterile class A), provided it still complies with Directive 98/79/EC, has no significant change in design or intended purpose, presents no unacceptable risk, the manufacturer had a quality management system by 26 May 2025 and lodged a notified-body application by 26 May 2025, 2026 or 2027 and signed the written agreement by 26 September 2025, 2026 or 2027; the IVDR rules on post-market surveillance, vigilance, market surveillance, registration and Article 10a already apply, and devices lawfully placed on the market may continue to be made available without a sell-off deadline.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(2), (3), (3a) to (3d), (4) and (11)" }, { "categories": [ "performance-study-device" ], "roles": [ "manufacturer", "other", "importer", "distributor" ], "size": "any", "result": "in-scope", "note": "Devices for performance study fall under the regulation but follow Articles 57 to 77 and Annexes XIII and XIV instead of the conformity assessment procedures: they carry no CE marking, need no UDI, and studies with surgically invasive sampling, interventional clinical performance studies, studies with additional invasive procedures or risks and studies involving companion diagnostics (other than on left-over samples) need Member State authorisation and an ethics committee opinion; the sponsor must be established in the Union or have a legal representative there.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 19, Art. 24(1), Art. 48(11), Art. 57 and Art. 58" }, { "categories": [ "companion-diagnostic" ], "roles": [ "manufacturer", "other", "importer", "distributor" ], "size": "any", "result": "in-scope", "note": "A companion diagnostic is class C under rule 3, point (f), of Annex VIII; its conformity assessment involves a notified body that, for every device, assesses the technical documentation and consults the competent authority for the corresponding medicinal product or the European Medicines Agency on the device's suitability, and performance studies involving companion diagnostics follow the authorisation rules of Article 58 unless they use only left-over samples.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 2, point (7), Art. 48(3), (4), (7) and (8), Art. 58(2) and Annex VIII, Section 2.3, point (f)" }, { "categories": [ "self-testing-device" ], "roles": [ "manufacturer", "other", "importer", "distributor" ], "size": "any", "result": "in-scope", "note": "Devices for self-testing are class C under rule 4, except pregnancy, fertility and cholesterol tests and tests for glucose, erythrocytes, leucocytes and bacteria in urine, which are class B; near-patient tests are classified in their own right; in classes B, C and D the notified body additionally assesses the technical documentation under Section 5.1 of Annex IX, and the label and instructions must be easily understandable and in the official language(s) of the Member State where the device reaches the user.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 2, points (5) and (6), Art. 10(10), Art. 48(3), (7) and (9) and Annex VIII, Section 2.4" }, { "categories": [ "class-a-device", "class-a-sterile-device", "class-b-device", "class-c-device", "class-d-device" ], "roles": [ "manufacturer", "other", "importer", "distributor" ], "size": "any", "result": "in-scope", "note": "A device may be placed on the market or put into service only if it complies with the regulation: classification under the seven rules of Annex VIII drives the conformity route, from the manufacturer's own EU declaration of conformity for non-sterile class A to Annex IX (or Annex X plus XI) with a notified body for class B, C and D and for the sterility aspects of sterile class A; the obligations fall on the manufacturer, authorised representative, importer and distributor and contain no company-size threshold, only the proportionate quality management system and the outsourcing option for the person responsible for regulatory compliance in micro and small enterprises.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(1), Art. 10(8), Art. 15(2), Art. 47 and Art. 48" }, { "categories": [ "*" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Whether the regulation applies turns on whether the manufacturer intends the product for in vitro examination of human specimens, whether an Article 1(3) exclusion or the Article 5(5) health-institution exemption applies, and which economic-operator role you hold.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 1, Art. 2 and Art. 5(5)" } ] }, "obligations": { "manufacturer": [ { "text": "Design and manufacture the device to the general safety and performance requirements of Annex I for its intended purpose, run a documented risk management system, and demonstrate conformity through a performance evaluation under Article 56 and Annex XIII that establishes scientific validity, analytical performance and clinical performance, with clinical performance studies unless reliance on other data is justified, and a post-market performance follow-up plan; the performance evaluation report is part of the technical documentation and is updated at least annually for class C and D devices.", "id": "ivdr-mfr-design-manufacture-device", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(2) and (3), Art. 10(1) to (3) and Art. 56" }, { "text": "Design and manufacture the device so that it meets the general safety and performance requirements of Annex I that apply to it, taking its intended purpose into account.", "id": "ivdr-mfr-design-to-annex-i", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(2) and Art. 10(1)" }, { "text": "Establish, document, implement and maintain a risk management system for the device, as a continuous process throughout its lifecycle.", "id": "ivdr-mfr-run-risk-management", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(2)" }, { "text": "Conduct a performance evaluation under Article 56 and Annex XIII that establishes scientific validity, analytical performance and clinical performance, with a post-market performance follow-up plan; keep the report in the technical documentation and update it at least annually for class C and D devices.", "id": "ivdr-mfr-conduct-performance-evaluation", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(3), Art. 10(3) and Art. 56" }, { "text": "Classify the device into class A, B, C or D using the seven rules and ten implementing rules of Annex VIII and run the matching conformity assessment before placing it on the market: Annex IX Chapters I, II and III (or Annex X with Annex XI) with technical-documentation assessment of every device, EU reference laboratory testing and, where no common specification exists, an expert-panel consultation for class D; Annex IX Chapters I and III with assessment of at least one representative device per generic device group (or Annex X with XI) for class C; Annex IX Chapters I and III with one representative device per category for class B; the EU declaration of conformity on your own technical documentation for class A, with a notified body for the sterility aspects only where the device is sterile; plus Section 5.1 of Annex IX for self-testing and near-patient tests and the medicinal-product consultation of Section 5.2 for companion diagnostics.", "id": "ivdr-mfr-classify-device-class", "kind": "decision", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 47(1) and Art. 48(1) to (10)" }, { "text": "Classify the device into class A, B, C or D using the seven classification rules and the implementing rules of Annex VIII.", "id": "ivdr-mfr-classify-device", "kind": "decision", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 47(1) and Annex VIII" }, { "text": "Before placing the device on the market, run the conformity assessment procedure of Article 48 for its class: Annex IX or Annex X with XI through a notified body for classes B, C and D, and self-declaration for class A, with a notified body only for sterile aspects.", "id": "ivdr-mfr-run-conformity-assessment", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 48(1) to (10)" }, { "text": "Draw up and keep up to date the technical documentation of Annexes II and III, draw up the EU declaration of conformity with the Annex IV content and the Basic UDI-DI, translated into the languages the Member States require, affix the CE marking followed by the notified body's number where applicable, and keep the documentation, declaration and certificates available to authorities for at least 10 years after the last device covered by the declaration was placed on the market; notified-body certificates run for at most 5 years and are renewable.", "id": "ivdr-mfr-draw-keep-date", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(4), (5) and (7), Art. 17, Art. 18, Art. 24(6) and Art. 51(2)" }, { "text": "Draw up and keep up to date the technical documentation of Annexes II and III, including the post-market surveillance documentation.", "id": "ivdr-mfr-draw-technical-documentation", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(4)" }, { "text": "Draw up the EU declaration of conformity with the Annex IV content and the Basic UDI-DI, translated into the languages the Member States where the device is made available require, and keep it up to date.", "id": "ivdr-mfr-draw-eu-declaration", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "declaration-of-conformity", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(5) and Art. 17" }, { "text": "Affix the CE marking to the device, followed by the identification number of the notified body where a notified body was involved in the conformity assessment.", "id": "ivdr-mfr-affix-ce-marking", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(5) and Art. 18" }, { "text": "Keep the technical documentation, the EU declaration of conformity and any certificates available to the competent authorities for at least 10 years after the last device covered by the declaration was placed on the market.", "id": "ivdr-mfr-keep-documentation-years", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(7)" }, { "text": "Operate a quality management system proportionate to the risk class and type of device that covers the thirteen elements of Article 10(8), from regulatory strategy, risk management and performance evaluation to UDI verification, post-market surveillance, vigilance and corrective actions, keep series production in conformity, and have at least one person responsible for regulatory compliance with the Article 15 qualifications in the organisation, or permanently at your disposal if you are a micro or small enterprise.", "id": "ivdr-mfr-operate-quality-management", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(8) and Art. 15(1) to (3)" }, { "text": "Operate and keep up to date a quality management system, proportionate to the risk class and type of device, that covers the elements of Article 10(8) and keeps series production in conformity.", "id": "ivdr-mfr-operate-qms", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(8)" }, { "text": "Have within your organisation at least one person responsible for regulatory compliance with the Article 15 qualifications or, as a micro or small enterprise, have such a person permanently and continuously at your disposal.", "id": "ivdr-mfr-appoint-prrc", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 15(1) to (3)" }, { "text": "Assign a UDI (UDI-DI and UDI-PI) from a designated issuing entity to every device other than devices for performance study and to all higher packaging levels, place the UDI carrier on the label and packaging within the class-based dates of Article 113(3), point (e) (class D since 26 May 2023, classes B and C since 26 May 2025, class A from 26 May 2027), keep a list of all UDIs in the technical documentation, and assign a Basic UDI-DI and submit the Annex VI core data to the UDI database before placing the device on the market, and before applying to a notified body where one is involved.", "id": "ivdr-mfr-assign-udi-udi-di", "kind": "data", "level": "unit", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 24(1), (3), (4) and (7), Art. 26(1) and (2) and Art. 113(3), point (e)" }, { "text": "Assign a UDI (UDI-DI and UDI-PI) from a designated issuing entity to each device and higher packaging level, place the UDI carrier on the label and packaging by the class-based dates of Article 113(3)(e), and keep the list of UDIs in the technical documentation.", "id": "ivdr-mfr-assign-udi-carrier", "kind": "data", "level": "unit", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 24(1), (3), (4) and (7) and Art. 113(3), point (e)" }, { "text": "Assign a Basic UDI-DI and submit the Annex VI core data to the UDI database before placing the device on the market, and before applying to a notified body where one is involved.", "id": "ivdr-mfr-submit-udi-database", "kind": "submission", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 26(1) and (2)" }, { "text": "Register as an actor in Eudamed to obtain a single registration number before placing a device on the market (and before applying to a notified body), update the data within one week of any change, confirm it after one year and every second year, and register each device in Eudamed: the registration modules are mandatory from 28 May 2026 and devices placed on the market from that date must be entered no later than 28 November 2026.", "id": "ivdr-mfr-register-actor-eudamed", "kind": "submission", "level": "company", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 26(3), Art. 28 and Art. 113(3), points (f) and (fa); https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1" }, { "text": "Register as an actor in Eudamed to obtain a single registration number before placing a device on the market and before applying to a notified body.", "id": "ivdr-mfr-register-actor-srn", "kind": "submission", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 28; https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1" }, { "text": "Update your Eudamed actor data within one week of any change, and confirm its accuracy one year after registration and every second year thereafter.", "id": "ivdr-mfr-confirm-actor-data", "kind": "submission", "level": "company", "timing": "periodic", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 28; https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1" }, { "text": "Register each device in Eudamed: the registration modules are mandatory from 28 May 2026, and devices placed on the market from that date must be entered no later than 28 November 2026.", "id": "ivdr-mfr-register-devices-eudamed", "kind": "submission", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 26(3) and Art. 113(3), points (f) and (fa); https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1" }, { "text": "Supply the label and instructions for use with the Annex I, Section 20 information in the official language(s) of the Member State where the device reaches the user or patient, with indelible and legible label particulars and, for self-testing and near-patient tests, information that is easily understandable; for class C and D devices draw up a summary of safety and performance, validated by the notified body and published in Eudamed, and state on the label or instructions where it is available; and do not use claims, names or pictures that mislead on intended purpose, safety or performance.", "id": "ivdr-mfr-supply-label-instructions", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 7, Art. 10(10) and Art. 29" }, { "text": "Supply the label and instructions for use with the Annex I, Section 20 information in the official language(s) of the Member State where the device reaches the user or patient, indelible and legible, and easily understandable for self-testing and near-patient tests.", "id": "ivdr-mfr-supply-label-ifu", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(10)" }, { "text": "For class C and D devices, draw up a summary of safety and performance, have it validated by the notified body for publication in Eudamed, and state on the label or instructions where it is available.", "id": "ivdr-mfr-draw-safety-performance-summary", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 29" }, { "text": "Do not use text, names, trademarks, pictures or signs in labelling, instructions, making available or advertising that mislead the user or patient on the device's intended purpose, safety or performance.", "id": "ivdr-mfr-avoid-misleading-claims", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 7" }, { "text": "Plan, run and update a post-market surveillance system with a plan in the technical documentation, and produce a post-market surveillance report for class A and B devices or a periodic safety update report for class C and D devices updated at least annually, submitted through the electronic system to the notified body for class D devices and made available to the notified body for class C devices.", "id": "ivdr-mfr-plan-run-update", "kind": "procedure", "level": "product", "timing": "periodic", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(9) and Art. 78 to 81" }, { "text": "Plan, run and keep up to date a post-market surveillance system proportionate to the risk class, based on a post-market surveillance plan that is part of the technical documentation.", "id": "ivdr-mfr-run-pms-system", "kind": "procedure", "level": "product", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(9), Art. 78 and Art. 79" }, { "text": "Produce a post-market surveillance report for class A and B devices, or for class C and D devices a periodic safety update report updated at least annually, submitted through Eudamed to the notified body for class D and made available to it for class C.", "id": "ivdr-mfr-produce-pms-report-psur", "kind": "evidence", "level": "product", "timing": "periodic", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 80 and Art. 81" }, { "text": "Report serious incidents through the vigilance system immediately and no later than 15 days after becoming aware, 2 days for a serious public health threat and 10 days for a death or unanticipated serious deterioration in health; report field safety corrective actions in advance except in urgent cases, issue field safety notices to users, investigate incidents and provide a final report, and submit trend reports for statistically significant increases in non-serious incidents or in expected erroneous results.", "id": "ivdr-mfr-report-serious-incidents", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(12) and Art. 82 to 84" }, { "text": "Report each serious incident to the competent authority immediately and no later than 15 days after becoming aware, 2 days for a serious public health threat and 10 days for a death or unanticipated serious deterioration in health; investigate it and provide a final report.", "id": "ivdr-mfr-report-serious-incident", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(12), Art. 82(1)(a) and (3) to (5) and Art. 84" }, { "text": "Report each field safety corrective action to the competent authorities before undertaking it, except in urgent cases, and bring it to the users' attention without delay through a field safety notice.", "id": "ivdr-mfr-report-field-safety-action", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 82(1)(b) and Art. 84(8)" }, { "text": "Report any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or in expected erroneous results, that could significantly affect the benefit-risk analysis.", "id": "ivdr-mfr-submit-trend-reports", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 83" }, { "text": "Take immediate corrective action, withdrawal or recall where a device you placed on the market does not conform, inform distributors, the authorised representative and importers, and where the device presents a serious risk inform the competent authorities and the notified body; on request provide all conformity information in the language the Member State determines, samples or access, and cooperate on risk-mitigation measures; keep proportionate financial coverage for product liability.", "id": "ivdr-mfr-take-immediate-corrective", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(11), (13) and (15)" }, { "text": "Where a device you placed on the market does not conform, immediately take corrective action, withdraw or recall it, inform distributors, the authorised representative and importers, and where it presents a serious risk inform the competent authorities and the notified body.", "id": "ivdr-mfr-take-corrective-action", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(11)" }, { "text": "On a competent authority's request, provide all information and documentation demonstrating conformity in the language the Member State determines, provide samples or access to the device, and cooperate on measures to eliminate or mitigate risks.", "id": "ivdr-mfr-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(13)" }, { "text": "Have measures in place to provide sufficient financial coverage for your potential liability for defective devices, proportionate to the risk class, type of device and size of the enterprise.", "id": "ivdr-mfr-hold-liability-coverage", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(15)" }, { "text": "Give the competent authority of your or your authorised representative's Member State and your direct customers, health institutions and healthcare professionals at least 6 months' notice of an anticipated interruption or discontinuation of supply of a device that could foreseeably cause serious harm to patients or public health, stating the reasons; the duty applies since 10 January 2025 and covers legacy devices, and in Denmark the notice goes to Lægemiddelstyrelsen.", "id": "ivdr-mfr-give-competent-authority", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10a and Art. 110(11); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 3; https://laegemiddelstyrelsen.dk/da/udstyr/forsyningsafbrydelse-eller-forsyningsophoer-af-medicinsk-udstyr/" }, { "text": "If you are established outside the Union, designate a sole authorised representative under a written mandate covering at least the Article 11(3) tasks and keep the documentation permanently available to it; and if you offer devices or a diagnostic service to persons in the Union online, comply with the regulation and provide a copy of the EU declaration of conformity on request.", "id": "ivdr-mfr-designate-sole-authorised", "kind": "decision", "level": "company", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 6, Art. 10(7), third subparagraph, and Art. 11(1)" }, { "text": "If you are established outside the Union, designate a sole authorised representative under a written mandate covering at least the Article 11(3) tasks, and keep the technical documentation permanently available to it.", "id": "ivdr-mfr-designate-authorised-representative", "kind": "evidence", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10(7), third subparagraph, and Art. 11(1)" }, { "text": "If you offer devices or a diagnostic service to persons in the Union online or by other distance means, make sure the device complies with this regulation and provide a copy of the EU declaration of conformity on an authority's request.", "id": "ivdr-mfr-comply-distance-sales", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 6" } ], "other": [ { "text": "Accept the written mandate, which is effective at least for all devices of the same generic device group, perform the tasks it specifies and provide a copy to the competent authority on request; the mandate cannot delegate the manufacturer's core duties in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).", "id": "ivdr-oth-accept-written-mandate", "kind": "evidence", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(2) to (4)" }, { "text": "Verify that the EU declaration of conformity and technical documentation have been drawn up and that the applicable conformity assessment was carried out, and keep a copy of the technical documentation, the declaration and any certificate at the disposal of the competent authorities for 10 years after the last device was placed on the market.", "id": "ivdr-oth-verify-declaration-conformity", "kind": "verification", "level": "product", "timing": "ongoing", "sharedKey": "technical-documentation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), points (a) and (b), and Art. 10(7)" }, { "text": "Verify that the EU declaration of conformity and the technical documentation have been drawn up and that the manufacturer has carried out the applicable conformity assessment procedure.", "id": "ivdr-oth-verify-declaration-documentation", "kind": "verification", "level": "product", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), point (a)" }, { "text": "Keep a copy of the technical documentation, the EU declaration of conformity and any certificate at the disposal of the competent authorities for 10 years after the last device covered by the declaration was placed on the market.", "id": "ivdr-oth-keep-documentation-copy", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), point (b), and Art. 10(7)" }, { "text": "Register in Eudamed to obtain your own single registration number, verify that the manufacturer has met its device registration obligations, and keep your actor data updated and confirmed.", "id": "ivdr-oth-register-eudamed-obtain", "kind": "submission", "level": "company", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), point (c), and Art. 28" }, { "text": "Register in Eudamed to obtain your own single registration number, and keep your actor data updated and confirmed.", "id": "ivdr-oth-register-actor-srn", "kind": "submission", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 28" }, { "text": "Verify that the manufacturer has complied with its registration obligations for the device and for itself.", "id": "ivdr-oth-verify-manufacturer-registration", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), point (c)" }, { "text": "On request, provide the competent authority with all information and documentation demonstrating conformity in the language it determines, forward requests for samples or access to the manufacturer and verify that the authority receives them, and cooperate on preventive or corrective action.", "id": "ivdr-oth-provide-competent-authority", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), points (d) to (f)" }, { "text": "Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents, and terminate the mandate if the manufacturer acts contrary to its obligations, informing the competent authority and the notified body of the termination and its reasons.", "id": "ivdr-oth-immediately-inform-manufacturer", "kind": "evidence", "level": "product", "timing": "on-event", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), points (g) and (h), and Art. 11(6)" }, { "text": "Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device covered by your mandate.", "id": "ivdr-oth-forward-complaints-manufacturer", "kind": "evidence", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), point (g)" }, { "text": "Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation, and inform the competent authority of your Member State and, where applicable, the notified body of the termination and its reasons.", "id": "ivdr-oth-terminate-mandate-breach", "kind": "submission", "level": "company", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(3), point (h), and Art. 11(6)" }, { "text": "Have permanently and continuously at your disposal at least one person responsible for regulatory compliance with a relevant degree plus one year's experience or four years' experience in regulatory affairs or quality management for in vitro diagnostic medical devices.", "id": "ivdr-oth-have-permanently-continuously", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 15(6)" }, { "text": "Expect joint and several liability with the manufacturer for defective devices where a non-EU manufacturer has not complied with Article 10, and define a change of authorised representative in a written agreement covering the dates, documents and the forwarding of complaints.", "id": "ivdr-oth-expect-joint-several", "kind": "decision", "level": "company", "timing": "on-event", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(5) and Art. 12" }, { "text": "Where the non-EU manufacturer has not complied with its Article 10 obligations, you are legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.", "id": "ivdr-oth-joint-several-liability", "kind": "status", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 11(5)" }, { "text": "On a change of authorised representative, define the change in an agreement between the manufacturer, the outgoing and the incoming representative covering the end and start dates of the mandates, the transfer of documents and the forwarding of complaints and incident reports.", "id": "ivdr-oth-agree-change-representative", "kind": "evidence", "level": "company", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 12" } ], "importer": [ { "text": "Place only conforming devices on the Union market and, before doing so, verify that the device is CE-marked and the EU declaration of conformity drawn up, that a manufacturer is identified and an authorised representative designated, that the device is labelled and accompanied by instructions for use as required, and that a UDI has been assigned where applicable; hold non-conforming devices back and inform the manufacturer and its representative, and the competent authority where the device presents a serious risk or is falsified.", "id": "ivdr-imp-place-conforming-devices", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(1) and (2)" }, { "text": "Indicate your name, registered trade name or trade mark, registered place of business and contact address on the device, its packaging or an accompanying document without obscuring the manufacturer's label; if you translate the information or repackage the device, follow the Article 16(2) to (4) conditions, including a notified-body certificate for your quality management system and 28 days' notice to the manufacturer and the competent authority.", "id": "ivdr-imp-indicate-name-registered", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(3) and Art. 16(2) to (4)" }, { "text": "Indicate your name, registered trade name or registered trade mark, registered place of business and contact address on the device, its packaging or an accompanying document, without obscuring the manufacturer's label.", "id": "ivdr-imp-indicate-name-address", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(3)" }, { "text": "If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the device available.", "id": "ivdr-imp-relabel-repackage-conditions", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 16(2) to (4)" }, { "text": "Verify that the device is registered in Eudamed, add your details to the registration, register yourself as an actor to obtain a single registration number, and within two weeks of placing a device on the market check that the manufacturer or authorised representative has entered the actor information; in Denmark, Lægemiddelstyrelsen verifies your actor data before Eudamed issues the number and asks importers to state the risk classes of the devices they import.", "id": "ivdr-imp-verify-device-registered", "kind": "verification", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(4), Art. 27(3) and Art. 28; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/" }, { "text": "Verify that the device is registered in Eudamed and add your details to the registration, and within two weeks of placing it on the market check that the manufacturer or authorised representative has entered the actor information.", "id": "ivdr-imp-verify-device-registration", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(4) and Art. 27(3)" }, { "text": "Register as an actor in Eudamed to obtain a single registration number; in Denmark, Lægemiddelstyrelsen verifies your actor data before the number is issued and asks you to state the risk classes of the devices you import.", "id": "ivdr-imp-register-actor-srn", "kind": "submission", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 28; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/" }, { "text": "Keep storage and transport conditions from jeopardising compliance with Annex I and follow the manufacturer's conditions, and keep a register of complaints, non-conforming devices, recalls and withdrawals, sharing the information the manufacturer, authorised representative and distributors need to investigate complaints.", "id": "ivdr-imp-keep-storage-transport", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(5) and (6)" }, { "text": "While a device is under your responsibility, keep storage and transport conditions from jeopardising its compliance with Annex I and follow the conditions set by the manufacturer.", "id": "ivdr-imp-ensure-storage-transport", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(5)" }, { "text": "Keep a register of complaints, non-conforming devices, recalls and withdrawals, and give the manufacturer, authorised representative and distributors the information they need to investigate complaints.", "id": "ivdr-imp-keep-complaints-register", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(6)" }, { "text": "Where a device you placed on the market does not conform, immediately inform the manufacturer and its representative and cooperate on corrective action, withdrawal or recall; where it presents a serious risk also inform the competent authorities and the notified body; and forward complaints and suspected-incident reports from healthcare professionals, patients or users to the manufacturer and its representative immediately.", "id": "ivdr-imp-immediately-inform-manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(7) and (8)" }, { "text": "Where a device you placed on the market does not conform, immediately inform the manufacturer and its authorised representative and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, also inform the competent authorities and the notified body.", "id": "ivdr-imp-inform-nonconformity", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(7)" }, { "text": "Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and its authorised representative.", "id": "ivdr-imp-forward-complaints", "kind": "evidence", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(8)" }, { "text": "Keep a copy of the EU declaration of conformity and any certificate for the Article 10(7) period of 10 years, cooperate with competent authorities on risk-elimination measures, provide free samples or access to the device on request, and be able to identify to the authority every operator you supplied or were supplied by and every health institution or professional you supplied directly.", "id": "ivdr-imp-keep-copy-declaration", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(9) and (10) and Art. 22" }, { "text": "Keep a copy of the EU declaration of conformity and any certificate for the Article 10(7) period of at least 10 years after the last device was placed on the market.", "id": "ivdr-imp-keep-declaration-copy", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(9)" }, { "text": "Cooperate with the competent authorities, at their request, on measures to eliminate or mitigate risks, and provide free samples of the device or, where impracticable, access to it.", "id": "ivdr-imp-cooperate-provide-samples", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13(10)" }, { "text": "Be able to identify to the competent authority, for the Article 10(7) period, every economic operator you supplied or were supplied by and every health institution or healthcare professional you supplied directly.", "id": "ivdr-imp-identify-supply-chain", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 22" }, { "text": "If you market a device under your own name or trade mark, change its intended purpose or modify it in a way that may affect compliance, you assume the manufacturer's obligations, unless the manufacturer is identified on the label and contractually remains responsible.", "id": "ivdr-imp-change-intended-purpose", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 16(1)" } ], "distributor": [ { "text": "Act with due care and, before making a device available, verify (by representative sampling where allowed) that it is CE-marked with an EU declaration of conformity, accompanied by the manufacturer's label and instructions in the required language, that the importer has added its identification, and that a UDI has been assigned where applicable; hold non-conforming devices back, inform the manufacturer, its representative and the importer, and inform the competent authority where the device presents a serious risk or is falsified.", "id": "ivdr-dist-act-due-care", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(1) and (2)" }, { "text": "Keep storage and transport conditions in line with the manufacturer's conditions while the device is under your responsibility, which for reagents and controls typically means the cold chain stated on the label.", "id": "ivdr-dist-keep-storage-transport", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(3)" }, { "text": "Where a device you made available does not conform, immediately inform the manufacturer, its representative and the importer and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, immediately inform the competent authorities of the Member States concerned.", "id": "ivdr-dist-immediately-inform-manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(4)" }, { "text": "Forward complaints and suspected-incident reports from healthcare professionals, patients or users to the manufacturer, its representative and the importer immediately, and keep a register of complaints, non-conforming devices, recalls and withdrawals.", "id": "ivdr-dist-forward-complaints-suspected-incident", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(5)" }, { "text": "Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and, where applicable, its authorised representative and the importer.", "id": "ivdr-dist-forward-complaints", "kind": "evidence", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(5)" }, { "text": "Keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep the manufacturer, authorised representative and importer informed of that monitoring.", "id": "ivdr-dist-keep-complaints-register", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(5)" }, { "text": "On request, provide the competent authority with the information and documentation at your disposal demonstrating conformity, cooperate on risk-elimination measures, provide free samples or access to the device, and be able to identify every operator, health institution or professional you supplied directly for 10 years.", "id": "ivdr-dist-provide-competent-authority", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(6) and Art. 22" }, { "text": "On a competent authority's request, provide the information and documentation at your disposal demonstrating conformity, cooperate on measures to eliminate risks, and provide free samples of the device or access to it.", "id": "ivdr-dist-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 14(6)" }, { "text": "Be able to identify to the competent authority, for 10 years, every economic operator you supplied or were supplied by and every health institution or healthcare professional you supplied directly.", "id": "ivdr-dist-identify-supply-chain", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 22" }, { "text": "If you sell under your own name or trade mark, change the intended purpose or modify the device, you take on the manufacturer's obligations; if you translate the information or repackage the device, you need a quality management system certified by a notified body and must notify the manufacturer and the competent authority 28 days before making the relabelled or repackaged device available.", "id": "ivdr-dist-change-intended-purpose", "kind": "decision", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 16(1) to (4)" }, { "text": "If you make a device available under your own name or trade mark, change its intended purpose or modify it in a way that may affect compliance, you take on the manufacturer's obligations.", "id": "ivdr-dist-own-name-manufacturer", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 16(1)" }, { "text": "If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the device available.", "id": "ivdr-dist-relabel-repackage-conditions", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 16(2) to (4)" }, { "text": "Where national law requires it, register as a distributor: in Denmark, distributors and specialist retailers of IVDs established in Denmark register with Lægemiddelstyrelsen from 28 May 2026 through its own database, which stays a national registration outside Eudamed and carries a registration fee and an annual fee under bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr m.v. (in force 1 January 2026; registration fee DKK 1 238 and an annual supervision fee scaled by the number of employees).", "id": "ivdr-dist-register-distributor-denmark", "kind": "submission", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 27(2); https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-af-distributoer-og-specialforretning/; https://laegemiddelstyrelsen.dk/da/udstyr/gebyrer/; https://laegemiddelstyrelsen.dk/da/udstyr/lovgivning-og-vejledning/lovgivning/" } ] }, "requirements": [ { "id": "ivdr-mfr-design-manufacture-device", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "retired": "2026-09-24", "text": "Design and manufacture the device to the general safety and performance requirements of Annex I for its intended purpose, run a documented risk management system, and demonstrate conformity through a performance evaluation under Article 56 and Annex XIII that establishes scientific validity, analytical performance and clinical performance, with clinical performance studies unless reliance on other data is justified, and a post-market performance follow-up plan; the performance evaluation report is part of the technical documentation and is updated at least annually for class C and D devices.", "article": "Art. 5(2) and (3), Art. 10(1) to (3) and Art. 56", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-design-to-annex-i", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "Design and manufacture the device so that it meets the general safety and performance requirements of Annex I that apply to it, taking its intended purpose into account.", "article": "Art. 5(2) and Art. 10(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-run-risk-management", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "text": "Establish, document, implement and maintain a risk management system for the device, as a continuous process throughout its lifecycle.", "article": "Art. 10(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-conduct-performance-evaluation", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "Conduct a performance evaluation under Article 56 and Annex XIII that establishes scientific validity, analytical performance and clinical performance, with a post-market performance follow-up plan; keep the report in the technical documentation and update it at least annually for class C and D devices.", "article": "Art. 5(3), Art. 10(3) and Art. 56", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-classify-device-class", "role": "manufacturer", "kind": "decision", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "Classify the device into class A, B, C or D using the seven rules and ten implementing rules of Annex VIII and run the matching conformity assessment before placing it on the market: Annex IX Chapters I, II and III (or Annex X with Annex XI) with technical-documentation assessment of every device, EU reference laboratory testing and, where no common specification exists, an expert-panel consultation for class D; Annex IX Chapters I and III with assessment of at least one representative device per generic device group (or Annex X with XI) for class C; Annex IX Chapters I and III with one representative device per category for class B; the EU declaration of conformity on your own technical documentation for class A, with a notified body for the sterility aspects only where the device is sterile; plus Section 5.1 of Annex IX for self-testing and near-patient tests and the medicinal-product consultation of Section 5.2 for companion diagnostics.", "article": "Art. 47(1) and Art. 48(1) to (10)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-classify-device", "role": "manufacturer", "kind": "decision", "level": "product", "timing": "before-market", "text": "Classify the device into class A, B, C or D using the seven classification rules and the implementing rules of Annex VIII.", "article": "Art. 47(1) and Annex VIII", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-run-conformity-assessment", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "Before placing the device on the market, run the conformity assessment procedure of Article 48 for its class: Annex IX or Annex X with XI through a notified body for classes B, C and D, and self-declaration for class A, with a notified body only for sterile aspects.", "article": "Art. 48(1) to (10)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-draw-keep-date", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "text": "Draw up and keep up to date the technical documentation of Annexes II and III, draw up the EU declaration of conformity with the Annex IV content and the Basic UDI-DI, translated into the languages the Member States require, affix the CE marking followed by the notified body's number where applicable, and keep the documentation, declaration and certificates available to authorities for at least 10 years after the last device covered by the declaration was placed on the market; notified-body certificates run for at most 5 years and are renewable.", "article": "Art. 10(4), (5) and (7), Art. 17, Art. 18, Art. 24(6) and Art. 51(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-draw-technical-documentation", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "text": "Draw up and keep up to date the technical documentation of Annexes II and III, including the post-market surveillance documentation.", "article": "Art. 10(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-draw-eu-declaration", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "declaration-of-conformity", "text": "Draw up the EU declaration of conformity with the Annex IV content and the Basic UDI-DI, translated into the languages the Member States where the device is made available require, and keep it up to date.", "article": "Art. 10(5) and Art. 17", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-affix-ce-marking", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "text": "Affix the CE marking to the device, followed by the identification number of the notified body where a notified body was involved in the conformity assessment.", "article": "Art. 10(5) and Art. 18", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-keep-documentation-years", "role": "manufacturer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep the technical documentation, the EU declaration of conformity and any certificates available to the competent authorities for at least 10 years after the last device covered by the declaration was placed on the market.", "article": "Art. 10(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-operate-quality-management", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "text": "Operate a quality management system proportionate to the risk class and type of device that covers the thirteen elements of Article 10(8), from regulatory strategy, risk management and performance evaluation to UDI verification, post-market surveillance, vigilance and corrective actions, keep series production in conformity, and have at least one person responsible for regulatory compliance with the Article 15 qualifications in the organisation, or permanently at your disposal if you are a micro or small enterprise.", "article": "Art. 10(8) and Art. 15(1) to (3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-operate-qms", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Operate and keep up to date a quality management system, proportionate to the risk class and type of device, that covers the elements of Article 10(8) and keeps series production in conformity.", "article": "Art. 10(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-appoint-prrc", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Have within your organisation at least one person responsible for regulatory compliance with the Article 15 qualifications or, as a micro or small enterprise, have such a person permanently and continuously at your disposal.", "article": "Art. 15(1) to (3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-assign-udi-udi-di", "role": "manufacturer", "kind": "data", "level": "unit", "timing": "before-market", "retired": "2026-09-24", "text": "Assign a UDI (UDI-DI and UDI-PI) from a designated issuing entity to every device other than devices for performance study and to all higher packaging levels, place the UDI carrier on the label and packaging within the class-based dates of Article 113(3), point (e) (class D since 26 May 2023, classes B and C since 26 May 2025, class A from 26 May 2027), keep a list of all UDIs in the technical documentation, and assign a Basic UDI-DI and submit the Annex VI core data to the UDI database before placing the device on the market, and before applying to a notified body where one is involved.", "article": "Art. 24(1), (3), (4) and (7), Art. 26(1) and (2) and Art. 113(3), point (e)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-assign-udi-carrier", "role": "manufacturer", "kind": "data", "level": "unit", "timing": "before-market", "text": "Assign a UDI (UDI-DI and UDI-PI) from a designated issuing entity to each device and higher packaging level, place the UDI carrier on the label and packaging by the class-based dates of Article 113(3)(e), and keep the list of UDIs in the technical documentation.", "article": "Art. 24(1), (3), (4) and (7) and Art. 113(3), point (e)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-submit-udi-database", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "before-market", "text": "Assign a Basic UDI-DI and submit the Annex VI core data to the UDI database before placing the device on the market, and before applying to a notified body where one is involved.", "article": "Art. 26(1) and (2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-register-actor-eudamed", "role": "manufacturer", "kind": "submission", "level": "company", "timing": "before-market", "retired": "2026-09-24", "text": "Register as an actor in Eudamed to obtain a single registration number before placing a device on the market (and before applying to a notified body), update the data within one week of any change, confirm it after one year and every second year, and register each device in Eudamed: the registration modules are mandatory from 28 May 2026 and devices placed on the market from that date must be entered no later than 28 November 2026.", "article": "Art. 26(3), Art. 28 and Art. 113(3), points (f) and (fa); https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-register-actor-srn", "role": "manufacturer", "kind": "submission", "level": "company", "timing": "before-market", "text": "Register as an actor in Eudamed to obtain a single registration number before placing a device on the market and before applying to a notified body.", "article": "Art. 28; https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-confirm-actor-data", "role": "manufacturer", "kind": "submission", "level": "company", "timing": "periodic", "text": "Update your Eudamed actor data within one week of any change, and confirm its accuracy one year after registration and every second year thereafter.", "article": "Art. 28; https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-register-devices-eudamed", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "before-market", "text": "Register each device in Eudamed: the registration modules are mandatory from 28 May 2026, and devices placed on the market from that date must be entered no later than 28 November 2026.", "article": "Art. 26(3) and Art. 113(3), points (f) and (fa); https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-supply-label-instructions", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "retired": "2026-09-24", "text": "Supply the label and instructions for use with the Annex I, Section 20 information in the official language(s) of the Member State where the device reaches the user or patient, with indelible and legible label particulars and, for self-testing and near-patient tests, information that is easily understandable; for class C and D devices draw up a summary of safety and performance, validated by the notified body and published in Eudamed, and state on the label or instructions where it is available; and do not use claims, names or pictures that mislead on intended purpose, safety or performance.", "article": "Art. 7, Art. 10(10) and Art. 29", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-supply-label-ifu", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "text": "Supply the label and instructions for use with the Annex I, Section 20 information in the official language(s) of the Member State where the device reaches the user or patient, indelible and legible, and easily understandable for self-testing and near-patient tests.", "article": "Art. 10(10)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-draw-safety-performance-summary", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "For class C and D devices, draw up a summary of safety and performance, have it validated by the notified body for publication in Eudamed, and state on the label or instructions where it is available.", "article": "Art. 29", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-avoid-misleading-claims", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Do not use text, names, trademarks, pictures or signs in labelling, instructions, making available or advertising that mislead the user or patient on the device's intended purpose, safety or performance.", "article": "Art. 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-plan-run-update", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "periodic", "retired": "2026-09-24", "text": "Plan, run and update a post-market surveillance system with a plan in the technical documentation, and produce a post-market surveillance report for class A and B devices or a periodic safety update report for class C and D devices updated at least annually, submitted through the electronic system to the notified body for class D devices and made available to the notified body for class C devices.", "article": "Art. 10(9) and Art. 78 to 81", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-run-pms-system", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "ongoing", "text": "Plan, run and keep up to date a post-market surveillance system proportionate to the risk class, based on a post-market surveillance plan that is part of the technical documentation.", "article": "Art. 10(9), Art. 78 and Art. 79", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-produce-pms-report-psur", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "periodic", "text": "Produce a post-market surveillance report for class A and B devices, or for class C and D devices a periodic safety update report updated at least annually, submitted through Eudamed to the notified body for class D and made available to it for class C.", "article": "Art. 80 and Art. 81", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-report-serious-incidents", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "text": "Report serious incidents through the vigilance system immediately and no later than 15 days after becoming aware, 2 days for a serious public health threat and 10 days for a death or unanticipated serious deterioration in health; report field safety corrective actions in advance except in urgent cases, issue field safety notices to users, investigate incidents and provide a final report, and submit trend reports for statistically significant increases in non-serious incidents or in expected erroneous results.", "article": "Art. 10(12) and Art. 82 to 84", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-report-serious-incident", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "Report each serious incident to the competent authority immediately and no later than 15 days after becoming aware, 2 days for a serious public health threat and 10 days for a death or unanticipated serious deterioration in health; investigate it and provide a final report.", "article": "Art. 10(12), Art. 82(1)(a) and (3) to (5) and Art. 84", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-report-field-safety-action", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "Report each field safety corrective action to the competent authorities before undertaking it, except in urgent cases, and bring it to the users' attention without delay through a field safety notice.", "article": "Art. 82(1)(b) and Art. 84(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-submit-trend-reports", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "Report any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or in expected erroneous results, that could significantly affect the benefit-risk analysis.", "article": "Art. 83", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-take-immediate-corrective", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "text": "Take immediate corrective action, withdrawal or recall where a device you placed on the market does not conform, inform distributors, the authorised representative and importers, and where the device presents a serious risk inform the competent authorities and the notified body; on request provide all conformity information in the language the Member State determines, samples or access, and cooperate on risk-mitigation measures; keep proportionate financial coverage for product liability.", "article": "Art. 10(11), (13) and (15)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-take-corrective-action", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "Where a device you placed on the market does not conform, immediately take corrective action, withdraw or recall it, inform distributors, the authorised representative and importers, and where it presents a serious risk inform the competent authorities and the notified body.", "article": "Art. 10(11)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-provide-information-request", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a competent authority's request, provide all information and documentation demonstrating conformity in the language the Member State determines, provide samples or access to the device, and cooperate on measures to eliminate or mitigate risks.", "article": "Art. 10(13)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-hold-liability-coverage", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Have measures in place to provide sufficient financial coverage for your potential liability for defective devices, proportionate to the risk class, type of device and size of the enterprise.", "article": "Art. 10(15)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-give-competent-authority", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "Give the competent authority of your or your authorised representative's Member State and your direct customers, health institutions and healthcare professionals at least 6 months' notice of an anticipated interruption or discontinuation of supply of a device that could foreseeably cause serious harm to patients or public health, stating the reasons; the duty applies since 10 January 2025 and covers legacy devices, and in Denmark the notice goes to Lægemiddelstyrelsen.", "article": "Art. 10a and Art. 110(11); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 3; https://laegemiddelstyrelsen.dk/da/udstyr/forsyningsafbrydelse-eller-forsyningsophoer-af-medicinsk-udstyr/", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-designate-sole-authorised", "role": "manufacturer", "kind": "decision", "level": "company", "timing": "before-market", "retired": "2026-09-24", "text": "If you are established outside the Union, designate a sole authorised representative under a written mandate covering at least the Article 11(3) tasks and keep the documentation permanently available to it; and if you offer devices or a diagnostic service to persons in the Union online, comply with the regulation and provide a copy of the EU declaration of conformity on request.", "article": "Art. 6, Art. 10(7), third subparagraph, and Art. 11(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-designate-authorised-representative", "role": "manufacturer", "kind": "evidence", "level": "company", "timing": "before-market", "text": "If you are established outside the Union, designate a sole authorised representative under a written mandate covering at least the Article 11(3) tasks, and keep the technical documentation permanently available to it.", "article": "Art. 10(7), third subparagraph, and Art. 11(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-mfr-comply-distance-sales", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "If you offer devices or a diagnostic service to persons in the Union online or by other distance means, make sure the device complies with this regulation and provide a copy of the EU declaration of conformity on an authority's request.", "article": "Art. 6", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-accept-written-mandate", "role": "other", "kind": "evidence", "level": "company", "timing": "before-market", "text": "Accept the written mandate, which is effective at least for all devices of the same generic device group, perform the tasks it specifies and provide a copy to the competent authority on request; the mandate cannot delegate the manufacturer's core duties in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).", "article": "Art. 11(2) to (4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-verify-declaration-conformity", "role": "other", "kind": "verification", "level": "product", "timing": "ongoing", "sharedKey": "technical-documentation", "retired": "2026-09-24", "text": "Verify that the EU declaration of conformity and technical documentation have been drawn up and that the applicable conformity assessment was carried out, and keep a copy of the technical documentation, the declaration and any certificate at the disposal of the competent authorities for 10 years after the last device was placed on the market.", "article": "Art. 11(3), points (a) and (b), and Art. 10(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-verify-declaration-documentation", "role": "other", "kind": "verification", "level": "product", "timing": "ongoing", "text": "Verify that the EU declaration of conformity and the technical documentation have been drawn up and that the manufacturer has carried out the applicable conformity assessment procedure.", "article": "Art. 11(3), point (a)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-keep-documentation-copy", "role": "other", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep a copy of the technical documentation, the EU declaration of conformity and any certificate at the disposal of the competent authorities for 10 years after the last device covered by the declaration was placed on the market.", "article": "Art. 11(3), point (b), and Art. 10(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-register-eudamed-obtain", "role": "other", "kind": "submission", "level": "company", "timing": "before-market", "retired": "2026-09-24", "text": "Register in Eudamed to obtain your own single registration number, verify that the manufacturer has met its device registration obligations, and keep your actor data updated and confirmed.", "article": "Art. 11(3), point (c), and Art. 28", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-register-actor-srn", "role": "other", "kind": "submission", "level": "company", "timing": "before-market", "text": "Register in Eudamed to obtain your own single registration number, and keep your actor data updated and confirmed.", "article": "Art. 28", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-verify-manufacturer-registration", "role": "other", "kind": "verification", "level": "product", "timing": "before-market", "text": "Verify that the manufacturer has complied with its registration obligations for the device and for itself.", "article": "Art. 11(3), point (c)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-provide-competent-authority", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On request, provide the competent authority with all information and documentation demonstrating conformity in the language it determines, forward requests for samples or access to the manufacturer and verify that the authority receives them, and cooperate on preventive or corrective action.", "article": "Art. 11(3), points (d) to (f)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-immediately-inform-manufacturer", "role": "other", "kind": "evidence", "level": "product", "timing": "on-event", "retired": "2026-09-24", "text": "Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents, and terminate the mandate if the manufacturer acts contrary to its obligations, informing the competent authority and the notified body of the termination and its reasons.", "article": "Art. 11(3), points (g) and (h), and Art. 11(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-forward-complaints-manufacturer", "role": "other", "kind": "evidence", "level": "product", "timing": "on-event", "text": "Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device covered by your mandate.", "article": "Art. 11(3), point (g)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-terminate-mandate-breach", "role": "other", "kind": "submission", "level": "company", "timing": "on-event", "text": "Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation, and inform the competent authority of your Member State and, where applicable, the notified body of the termination and its reasons.", "article": "Art. 11(3), point (h), and Art. 11(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-have-permanently-continuously", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Have permanently and continuously at your disposal at least one person responsible for regulatory compliance with a relevant degree plus one year's experience or four years' experience in regulatory affairs or quality management for in vitro diagnostic medical devices.", "article": "Art. 15(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-expect-joint-several", "role": "other", "kind": "decision", "level": "company", "timing": "on-event", "retired": "2026-09-24", "text": "Expect joint and several liability with the manufacturer for defective devices where a non-EU manufacturer has not complied with Article 10, and define a change of authorised representative in a written agreement covering the dates, documents and the forwarding of complaints.", "article": "Art. 11(5) and Art. 12", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-joint-several-liability", "role": "other", "kind": "status", "level": "company", "timing": "ongoing", "text": "Where the non-EU manufacturer has not complied with its Article 10 obligations, you are legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.", "article": "Art. 11(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-oth-agree-change-representative", "role": "other", "kind": "evidence", "level": "company", "timing": "on-event", "text": "On a change of authorised representative, define the change in an agreement between the manufacturer, the outgoing and the incoming representative covering the end and start dates of the mandates, the transfer of documents and the forwarding of complaints and incident reports.", "article": "Art. 12", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-place-conforming-devices", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "Place only conforming devices on the Union market and, before doing so, verify that the device is CE-marked and the EU declaration of conformity drawn up, that a manufacturer is identified and an authorised representative designated, that the device is labelled and accompanied by instructions for use as required, and that a UDI has been assigned where applicable; hold non-conforming devices back and inform the manufacturer and its representative, and the competent authority where the device presents a serious risk or is falsified.", "article": "Art. 13(1) and (2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-indicate-name-registered", "role": "importer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "text": "Indicate your name, registered trade name or trade mark, registered place of business and contact address on the device, its packaging or an accompanying document without obscuring the manufacturer's label; if you translate the information or repackage the device, follow the Article 16(2) to (4) conditions, including a notified-body certificate for your quality management system and 28 days' notice to the manufacturer and the competent authority.", "article": "Art. 13(3) and Art. 16(2) to (4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-indicate-name-address", "role": "importer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Indicate your name, registered trade name or registered trade mark, registered place of business and contact address on the device, its packaging or an accompanying document, without obscuring the manufacturer's label.", "article": "Art. 13(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-relabel-repackage-conditions", "role": "importer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the device available.", "article": "Art. 16(2) to (4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-verify-device-registered", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "Verify that the device is registered in Eudamed, add your details to the registration, register yourself as an actor to obtain a single registration number, and within two weeks of placing a device on the market check that the manufacturer or authorised representative has entered the actor information; in Denmark, Lægemiddelstyrelsen verifies your actor data before Eudamed issues the number and asks importers to state the risk classes of the devices they import.", "article": "Art. 13(4), Art. 27(3) and Art. 28; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-verify-device-registration", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "Verify that the device is registered in Eudamed and add your details to the registration, and within two weeks of placing it on the market check that the manufacturer or authorised representative has entered the actor information.", "article": "Art. 13(4) and Art. 27(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-register-actor-srn", "role": "importer", "kind": "submission", "level": "company", "timing": "before-market", "text": "Register as an actor in Eudamed to obtain a single registration number; in Denmark, Lægemiddelstyrelsen verifies your actor data before the number is issued and asks you to state the risk classes of the devices you import.", "article": "Art. 28; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-keep-storage-transport", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "text": "Keep storage and transport conditions from jeopardising compliance with Annex I and follow the manufacturer's conditions, and keep a register of complaints, non-conforming devices, recalls and withdrawals, sharing the information the manufacturer, authorised representative and distributors need to investigate complaints.", "article": "Art. 13(5) and (6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-ensure-storage-transport", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "While a device is under your responsibility, keep storage and transport conditions from jeopardising its compliance with Annex I and follow the conditions set by the manufacturer.", "article": "Art. 13(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-keep-complaints-register", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep a register of complaints, non-conforming devices, recalls and withdrawals, and give the manufacturer, authorised representative and distributors the information they need to investigate complaints.", "article": "Art. 13(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-immediately-inform-manufacturer", "role": "importer", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "text": "Where a device you placed on the market does not conform, immediately inform the manufacturer and its representative and cooperate on corrective action, withdrawal or recall; where it presents a serious risk also inform the competent authorities and the notified body; and forward complaints and suspected-incident reports from healthcare professionals, patients or users to the manufacturer and its representative immediately.", "article": "Art. 13(7) and (8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-inform-nonconformity", "role": "importer", "kind": "submission", "level": "product", "timing": "on-event", "text": "Where a device you placed on the market does not conform, immediately inform the manufacturer and its authorised representative and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, also inform the competent authorities and the notified body.", "article": "Art. 13(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-forward-complaints", "role": "importer", "kind": "evidence", "level": "product", "timing": "on-event", "text": "Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and its authorised representative.", "article": "Art. 13(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-keep-copy-declaration", "role": "importer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "text": "Keep a copy of the EU declaration of conformity and any certificate for the Article 10(7) period of 10 years, cooperate with competent authorities on risk-elimination measures, provide free samples or access to the device on request, and be able to identify to the authority every operator you supplied or were supplied by and every health institution or professional you supplied directly.", "article": "Art. 13(9) and (10) and Art. 22", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-keep-declaration-copy", "role": "importer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep a copy of the EU declaration of conformity and any certificate for the Article 10(7) period of at least 10 years after the last device was placed on the market.", "article": "Art. 13(9)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-cooperate-provide-samples", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "Cooperate with the competent authorities, at their request, on measures to eliminate or mitigate risks, and provide free samples of the device or, where impracticable, access to it.", "article": "Art. 13(10)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-identify-supply-chain", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify to the competent authority, for the Article 10(7) period, every economic operator you supplied or were supplied by and every health institution or healthcare professional you supplied directly.", "article": "Art. 22", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-imp-change-intended-purpose", "role": "importer", "kind": "status", "level": "product", "timing": "before-market", "text": "If you market a device under your own name or trade mark, change its intended purpose or modify it in a way that may affect compliance, you assume the manufacturer's obligations, unless the manufacturer is identified on the label and contractually remains responsible.", "article": "Art. 16(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-act-due-care", "role": "distributor", "kind": "verification", "level": "product", "timing": "before-market", "text": "Act with due care and, before making a device available, verify (by representative sampling where allowed) that it is CE-marked with an EU declaration of conformity, accompanied by the manufacturer's label and instructions in the required language, that the importer has added its identification, and that a UDI has been assigned where applicable; hold non-conforming devices back, inform the manufacturer, its representative and the importer, and inform the competent authority where the device presents a serious risk or is falsified.", "article": "Art. 14(1) and (2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-keep-storage-transport", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep storage and transport conditions in line with the manufacturer's conditions while the device is under your responsibility, which for reagents and controls typically means the cold chain stated on the label.", "article": "Art. 14(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-immediately-inform-manufacturer", "role": "distributor", "kind": "submission", "level": "product", "timing": "on-event", "text": "Where a device you made available does not conform, immediately inform the manufacturer, its representative and the importer and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, immediately inform the competent authorities of the Member States concerned.", "article": "Art. 14(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-forward-complaints-suspected-incident", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "text": "Forward complaints and suspected-incident reports from healthcare professionals, patients or users to the manufacturer, its representative and the importer immediately, and keep a register of complaints, non-conforming devices, recalls and withdrawals.", "article": "Art. 14(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-forward-complaints", "role": "distributor", "kind": "evidence", "level": "product", "timing": "on-event", "text": "Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and, where applicable, its authorised representative and the importer.", "article": "Art. 14(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-keep-complaints-register", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep the manufacturer, authorised representative and importer informed of that monitoring.", "article": "Art. 14(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-provide-competent-authority", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "text": "On request, provide the competent authority with the information and documentation at your disposal demonstrating conformity, cooperate on risk-elimination measures, provide free samples or access to the device, and be able to identify every operator, health institution or professional you supplied directly for 10 years.", "article": "Art. 14(6) and Art. 22", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-provide-information-request", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a competent authority's request, provide the information and documentation at your disposal demonstrating conformity, cooperate on measures to eliminate risks, and provide free samples of the device or access to it.", "article": "Art. 14(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-identify-supply-chain", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify to the competent authority, for 10 years, every economic operator you supplied or were supplied by and every health institution or healthcare professional you supplied directly.", "article": "Art. 22", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-change-intended-purpose", "role": "distributor", "kind": "decision", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "If you sell under your own name or trade mark, change the intended purpose or modify the device, you take on the manufacturer's obligations; if you translate the information or repackage the device, you need a quality management system certified by a notified body and must notify the manufacturer and the competent authority 28 days before making the relabelled or repackaged device available.", "article": "Art. 16(1) to (4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-own-name-manufacturer", "role": "distributor", "kind": "status", "level": "product", "timing": "before-market", "text": "If you make a device available under your own name or trade mark, change its intended purpose or modify it in a way that may affect compliance, you take on the manufacturer's obligations.", "article": "Art. 16(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-relabel-repackage-conditions", "role": "distributor", "kind": "procedure", "level": "product", "timing": "before-market", "text": "If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the device available.", "article": "Art. 16(2) to (4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "id": "ivdr-dist-register-distributor-denmark", "role": "distributor", "kind": "submission", "level": "company", "timing": "before-market", "text": "Where national law requires it, register as a distributor: in Denmark, distributors and specialist retailers of IVDs established in Denmark register with Lægemiddelstyrelsen from 28 May 2026 through its own database, which stays a national registration outside Eudamed and carries a registration fee and an annual fee under bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr m.v. (in force 1 January 2026; registration fee DKK 1 238 and an annual supervision fee scaled by the number of employees).", "article": "Art. 27(2); https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-af-distributoer-og-specialforretning/; https://laegemiddelstyrelsen.dk/da/udstyr/gebyrer/; https://laegemiddelstyrelsen.dk/da/udstyr/lovgivning-og-vejledning/lovgivning/", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" } ], "requirementsHash": "96ce46dcd502cac0", "penalties": { "text": "Member States lay down the rules on penalties for infringements of the regulation and take all measures necessary to ensure that they are implemented; the penalties must be effective, proportionate and dissuasive and were notified to the Commission by 25 February 2022. Competent authorities check devices through documentation reviews, physical or laboratory checks and announced or unannounced inspections of economic operators, suppliers and subcontractors, may require documentation, information and free samples, and may confiscate, destroy or render inoperable devices that present an unacceptable risk or are falsified. Where a device presents an unacceptable risk they require corrective action, restriction, specific conditions, withdrawal or recall within a set period and, if the operator fails to act, prohibit or restrict the making available, withdraw or recall the device and notify the Commission and the other Member States through the market-surveillance module of Eudamed; other non-compliance must be ended within a set period, otherwise the same measures follow; a Member State may also take preventive health-protection measures against a category of devices. A manufacturer that fails to cooperate or provides incomplete information can see its device prohibited, restricted, withdrawn or recalled until it complies. In Denmark, Lægemiddelstyrelsen (the Danish Medicines Agency) supervises manufacturers and the other operators and applies lov om medicinsk udstyr, lovbekendtgørelse nr. 682 af 29. maj 2023, as amended by lov nr. 1759 of 29 December 2025, and bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (in force 1 January 2026, repealing bekendtgørelse nr. 837 af 20. juni 2023 om medicinsk udstyr m.v., the previous executive order on medical devices, under its § 21, stk. 2), with fees under bekendtgørelse nr. 839 af 20. juni 2023 om gebyrer for medicinsk udstyr m.v., som ændret ved bekendtgørelse af 6. december 2024 og bekendtgørelse nr. 1739 af 8. december 2025, and bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr m.v. (in force 1 January 2026; registration fee DKK 1 238 and an annual supervision fee scaled by the number of employees); the Danish product act (lov om produkter og markedsovervågning, consolidated as LBK nr. 22 of 8 January 2026) does not cover medical devices or in vitro diagnostics — neither Regulation (EU) 2017/745 nor Regulation (EU) 2017/746 appears in it — so the Danish framework for IVDs is the act on medical devices alone. Breaches of Regulation (EU) 2017/746, and failures to comply with an order, a prohibition or a duty to provide information under it, are punished in Denmark with a fine or imprisonment of up to 1 year and 6 months under section 6(2) of the Danish act on medical devices, executive orders made under the act may set fines of their own (section 6(3)) — executive order nr. 1731 of 8 December 2025 does so in its section 20 for, among other things, the incident-reporting and registration duties of its sections 8 to 15 — and companies can be held liable under chapter 5 of the criminal code (section 6(4)).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 106, Art. 10(13), Art. 88 to 94; https://www.retsinformation.dk/eli/lta/2023/682 · § 6, stk. 2, 3 og 4; https://www.retsinformation.dk/eli/lta/2025/1731 · § 20; https://www.retsinformation.dk/eli/lta/2026/22 · § 2; https://laegemiddelstyrelsen.dk/da/udstyr/lovgivning-og-vejledning/lovgivning/; https://laegemiddelstyrelsen.dk/da/udstyr/" }, "checklist": [ "Confirm the product is an IVD under Article 2, point (2): intended by you for in vitro examination of human specimens to provide one of the six kinds of information listed there; check that no Article 1(3) exclusion (general laboratory or research-use-only product, invasive sampling product, certified reference material, EQA material) applies and that a device with an integral medical device is handled under the MDR (Article 1(4)).", "Decide your role for each device: manufacturer, authorised representative, importer or distributor, remembering that own-brand sales, changing the intended purpose or modifying a device make you the manufacturer (Article 16); a health institution making its own tests checks the nine conditions of Article 5(5).", "Classify the device with the seven rules of Annex VIII, applying the implementing rules on accessories, software, calibrators and controls, and record the rationale; the class sets the conformity route, the PSUR cycle and the UDI label date (Article 47, Article 113(3), point (e)).", "Choose and book the conformity assessment: a notified body under Annex IX, X or XI for classes B, C and D and for the sterility aspects of sterile class A devices, with EU reference laboratory testing for class D, Section 5.1 for self-tests and near-patient tests and the medicinal-product consultation for companion diagnostics; the EU declaration of conformity alone for other class A devices (Article 48).", "Build the technical documentation of Annexes II and III with the risk management file, the performance evaluation plan and report covering scientific validity, analytical and clinical performance with a PMPF plan, the label and instructions in the Member State languages, and the post-market surveillance plan (Articles 10(4), 56, 79 and Annex XIII).", "Set up the quality management system of Article 10(8) and name the person responsible for regulatory compliance (Article 15); micro and small enterprises may contract the person externally.", "Register as an actor in Eudamed to get your single registration number, assign the Basic UDI-DI and UDIs, place the UDI carrier on labels and packaging, and register each device in Eudamed by 28 November 2026 for devices placed on the market from 28 May 2026 (Articles 24, 26, 28 and 113(3), points (f) and (fa)).", "Draw up the EU declaration of conformity with the Annex IV content, affix the CE marking with the notified body number, and for class C and D devices prepare the summary of safety and performance for validation and publication in Eudamed (Articles 17, 18 and 29).", "Run vigilance and surveillance: a procedure that reports serious incidents within 15, 10 or 2 days, field safety corrective actions and notices, trend reports including increases in expected erroneous results, the PMS report or annual PSUR, and a supply-interruption notice at least 6 months ahead (Articles 10a and 78 to 84).", "For legacy devices, map every directive certificate and declaration against 31 December 2027, 2028 or 2029, evidence the Article 110(3c) conditions (QMS and class D application by 26 May 2025, class C application by 26 May 2026, class B and sterile class A application by 26 May 2027, written agreements by the following 26 September) and apply the IVDR post-market, vigilance and registration rules already now (Article 110(3a) to (3d))." ], "faq": [ { "q": "When did the IVDR start to apply?", "a": "Regulation (EU) 2017/746 was adopted on 5 April 2017, published on 5 May 2017 and entered into force on 25 May 2017. It applies since 26 May 2022, five years after entry into force, and on that date Directive 98/79/EC was repealed subject to the transitional provisions of Article 110 and to the directive rules on vigilance, performance studies, registration and certificate notification that survive until the matching Eudamed module applies. The chapters on notified bodies and competent authorities applied from 26 November 2017 so that bodies could be designated in time, and Regulation (EU) 2022/112 kept the 2022 date but extended the transition for legacy devices because of COVID-19 and limited notified-body capacity.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 112 and Art. 113; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0112 · Art. 1" }, { "q": "Until when can legacy devices with a directive certificate or declaration still be placed on the market?", "a": "Regulation (EU) 2024/1860 extended the transition by risk class. Devices with a certificate issued under Directive 98/79/EC from 25 May 2017 that was still valid on 26 May 2022 may be placed on the market or put into service until 31 December 2027. Devices that needed no notified body under the directive, for which a declaration of conformity was drawn up before 26 May 2022 and which now need a notified body, may be placed on the market until 31 December 2027 for class D, 31 December 2028 for class C and 31 December 2029 for class B and for class A devices placed on the market sterile. The conditions are continued compliance with the directive, no significant change in design or intended purpose, no unacceptable risk, a quality management system by 26 May 2025, a formal notified-body application by 26 May 2025, 26 May 2026 or 26 May 2027 depending on the group, and a signed written agreement by 26 September 2025, 2026 or 2027; the IVDR rules on post-market surveillance, vigilance, market surveillance and registration already apply to these devices, and devices lawfully placed on the market may continue to be made available without a sell-off deadline. Non-sterile class A devices never needed a notified body and had to comply in full from 26 May 2022.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(2), (3), (3a), (3b), (3c), (3d) and (4); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 2; https://laegemiddelstyrelsen.dk/da/udstyr/eu-regler-om-medicinsk-udstyr/forlaenget-overgangsordning-for-ivd-udstyr/" }, { "q": "Which class is my test in, and do I need a notified body?", "a": "Annex VIII has seven classification rules. Rule 1 makes tests for transmissible agents in blood, tissues or organs for transfusion or transplantation, for life-threatening agents with a high risk of propagation and for the infectious load of life-threatening diseases class D; rule 2 makes blood grouping and tissue typing class C, but ABO, Rhesus, Kell, Kidd and Duffy markers class D; rule 3 lists thirteen class C purposes including sexually transmitted and other infectious agents, prenatal and newborn screening, companion diagnostics, cancer screening, diagnosis and staging, human genetic testing, therapeutic drug monitoring and the management of life-threatening conditions; rule 4 makes self-tests class C except pregnancy, fertility, cholesterol and urine glucose, erythrocyte, leucocyte and bacteria tests, which are class B, and classifies near-patient tests in their own right; rule 5 makes general laboratory products, IVD instruments and specimen receptacles class A; rule 6 puts everything else in class B and rule 7 controls without an assigned value in class B. Only non-sterile class A devices are self-declared; every class B, C and D device and the sterility aspects of a sterile class A device involve a notified body, and class D adds EU reference laboratory testing and, for a first certification without common specifications, an expert-panel opinion. The Commission's MDCG 2020-16 guidance on classification supports the assessment.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 47, Art. 48(3) to (10) and Annex VIII, Section 2; https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en" }, { "q": "When does Eudamed become mandatory for IVDs?", "a": "Regulation (EU) 2024/1860 lets Eudamed roll out module by module: the obligations linked to a module apply 6 months after the Commission publishes the notice that it is functional. Commission Decision (EU) 2025/2371, published on 27 November 2025, confirmed the four modules for actor registration, UDI and device registration, notified bodies and certificates, and market surveillance under both the MDR and the IVDR, so their use is mandatory from 28 May 2026, when manufacturers, authorised representatives and importers register in Eudamed instead of national databases. Devices placed on the market from that date must be entered no later than 6 months after it and notified bodies must enter their certificates no later than 12 months after it; the summary of safety and performance is uploaded once the certificate is in Eudamed. The vigilance and performance-study modules are still under development and will become mandatory only after their own notice, so until then the directive-era arrangements for vigilance reporting and performance studies continue.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 30 and Art. 113(3), points (f) to (fd); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1 and Art. 2; https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/" }, { "q": "Can a hospital laboratory keep using its own in-house tests?", "a": "Yes, under Article 5(5). Devices manufactured and used only within a health institution established in the Union are exempt from the regulation except the relevant general safety and performance requirements of Annex I, provided the devices are not transferred to another legal entity, are made and used under an appropriate quality management system, the laboratory complies with EN ISO 15189 or national accreditation rules, the institution gives its competent authority information on request, publishes a declaration identifying the devices and confirming that they meet Annex I, keeps class D-level documentation where required, manufactures to that documentation and reviews clinical experience. Those conditions apply since 26 May 2024; the further condition that the institution documents that no equivalent CE-marked device on the market meets the patient group's needs applies from 31 December 2030. The exemption never covers manufacture on an industrial scale, and Member States may restrict specific device types and inspect the institution. The Commission's MDCG 2023-1 guidance explains the exemption.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(4) and (5) and Art. 113(3), points (i) and (j); https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en" }, { "q": "How quickly must serious incidents be reported?", "a": "The manufacturer reports every serious incident involving a device on the Union market immediately after establishing a causal relationship, or that one is reasonably possible, and no later than 15 days after becoming aware of it; no later than 2 days for a serious public health threat and no later than 10 days for a death or an unanticipated serious deterioration in health. Expected erroneous results that are documented and quantified in the product information are not individual incidents but go into trend reporting. Field safety corrective actions are reported in advance except in urgent cases, an incomplete initial report may be followed by a complete one, and a report is due even when the manufacturer is unsure whether the incident is reportable. Healthcare professionals in Denmark must report serious incidents to Lægemiddelstyrelsen, patients and users may, and the agency then informs the manufacturer. In Denmark, executive order nr. 1731 of 8 December 2025 makes the manufacturer report serious incidents covered by Article 82(1), point (a), to Lægemiddelstyrelsen where the incident occurred in Denmark, send the agency the final investigation report under Article 84(5) and send it every field safety corrective action notice under Article 82(1), point (b); the operators of public and private hospitals must report immediately any incident with a device or IVD that has caused or could cause death or a serious deterioration in health (sections 8 to 11).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 82(1) to (8), (10) and (11) and Art. 83; https://www.retsinformation.dk/eli/lta/2025/1731 · §§ 8, 10 og 11; https://laegemiddelstyrelsen.dk/da/udstyr/indberetning-af-haendelser/" }, { "q": "What must an importer or distributor in Denmark do beyond the EU rules?", "a": "Importers verify the CE marking, declaration, labelling, authorised representative and UDI before placing a device on the market, add their own identification, register in Eudamed and add their details to the device registration. Distributors verify the same points before making the device available and forward complaints and incident reports. In Denmark, manufacturers, authorised representatives and importers register in Eudamed from 28 May 2026, with Lægemiddelstyrelsen verifying the company data within up to 14 days before Eudamed issues the single registration number, while distributors and specialist retailers of IVDs established in Denmark must register with Lægemiddelstyrelsen under the national rules, pay a registration fee and an annual fee, and remain outside Eudamed.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 13, Art. 14 and Art. 27(2); https://laegemiddelstyrelsen.dk/da/udstyr/registrering/; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-af-distributoer-og-specialforretning/" } ], "changelog": [ { "date": "2030-12-31", "kind": "applies", "title": "In-house devices: the no-equivalent-device condition applies", "summary": "Article 5(5), point (d), applies: a health institution may make and use an in-house device only if it documents that the target patient group's specific needs cannot be met, or not at the appropriate level of performance, by an equivalent device available on the market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(5), point (d), and Art. 113(3), point (j)" }, { "date": "2029-12-31", "kind": "applies", "title": "Transitional period ends for class B and sterile class A legacy devices", "summary": "Last day on which class B devices and class A devices placed on the market in sterile condition with a directive declaration of conformity drawn up before 26 May 2022 may be placed on the market or put into service; devices already placed on the market may continue to be made available.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3b), point (c), and Art. 110(4)" }, { "date": "2028-12-31", "kind": "applies", "title": "Transitional period ends for class C legacy devices", "summary": "Last day on which class C devices with a directive declaration of conformity drawn up before 26 May 2022 may be placed on the market or put into service under the transitional provisions.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3b), point (b)" }, { "date": "2027-12-31", "kind": "applies", "title": "Transitional period ends for class D legacy devices and all directive certificates", "summary": "Last day on which class D devices with a directive declaration and every device covered by a directive certificate may be placed on the market or put into service; certificates issued under Directive 98/79/EC from 25 May 2017 that were valid on 26 May 2022 expire at the latest on this date.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(2), second subparagraph, Art. 110(3a) and Art. 110(3b), point (a)" }, { "date": "2027-05-28", "kind": "applies", "title": "Notified-body certificates must be in Eudamed", "summary": "Twelve months after the Eudamed date of 28 May 2026, notified bodies must have entered the Article 51(5) certificate information in Eudamed, including the latest certificate for devices already on the market; the summary of safety and performance and certificate notifications follow the certificate entry.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), points (fb) and (fc); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 2" }, { "date": "2027-05-26", "kind": "applies", "title": "UDI carrier on class A labels; notified-body application deadline for class B and sterile class A legacy devices", "summary": "From this date the UDI carrier must appear on the label and packaging of class A devices, the last step of the class-based schedule; class B and sterile class A legacy devices may stay on the market beyond it only if a formal application has been lodged with a notified body.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (e), and Art. 110(3c), point (e)(iii)" }, { "date": "2026-11-28", "kind": "applies", "title": "Device registration backlog must be entered in Eudamed", "summary": "Six months after the Eudamed date, manufacturers must have entered the Article 26 information for devices placed on the market from 28 May 2026, including legacy devices placed on the market under Article 110(3), (3a) or (3b) unless already registered.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (fa); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 2" }, { "date": "2026-09-12", "kind": "guidance", "title": "Guide rebuilt from the consolidated text of 10 January 2025", "summary": "The body was rewritten from the consolidated text and the four amending acts: the earlier version gave only Regulation (EU) 2022/112 and undated staggered extensions for the transition; it now states the exact Article 110 dates of 31 December 2027, 2028 and 2029 after Regulation (EU) 2024/1860 with their conditions, the seven Annex VIII rules, the class-by-class conformity routes including the EU reference laboratory step for class D, the nine Article 5(5) conditions and their staggered application, the Eudamed timeline after Decision (EU) 2025/2371, Article 10a and the Danish registration rules. The Commission's proposal COM(2025) 1023 of 16 December 2025 to simplify the MDR and IVDR is a proposal under the ordinary legislative procedure, not law, and is mentioned as such.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(5), Art. 48, Art. 110 and Annex VIII; https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en" }, { "date": "2026-05-28", "kind": "applies", "title": "Eudamed mandatory for actors, devices, certificates and market surveillance", "summary": "Six months after Commission Decision (EU) 2025/2371, the obligations linked to the first four Eudamed modules apply: manufacturers, authorised representatives and importers register in Eudamed and obtain their single registration number there, devices are registered with their Basic UDI-DI and UDI data, and the corresponding directive-based national registration and certificate-notification rules are repealed; in Denmark, Lægemiddelstyrelsen verifies the actor data and continues to register distributors nationally.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 112 and Art. 113(3), point (f); https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/" }, { "date": "2026-05-26", "kind": "applies", "title": "Notified-body application deadline for class C legacy devices", "summary": "Class C devices with a directive declaration may stay on the market beyond this date only if the manufacturer or its authorised representative has lodged a formal application with a notified body; the written agreement follows by 26 September 2026.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3c), points (e)(ii) and (f)(ii)" }, { "date": "2025-12-29", "kind": "amendment", "title": "Denmark: stock and consumption reporting and a state preparedness scheme for medical devices", "summary": "Lov nr. 1759 of 29 December 2025 inserts sections 5 d and 5 e in the Danish act on medical devices: Lægemiddelstyrelsen may order municipalities and regions to report consumption and stock of medical devices, accessories and their parts where that is professionally necessary to assess whether a supply emergency or crisis has occurred or is imminent, and a state preparedness scheme for medical devices may be activated in whole or in part by the minister on the agency's recommendation, allowing orders, prohibitions and derogations towards municipalities and regions. The duty falls on public buyers, not on manufacturers, but it sits next to the Article 10a supply-interruption notice.", "source": "https://www.retsinformation.dk/eli/lta/2025/1759 · § 1; https://www.retsinformation.dk/eli/lta/2023/682 · §§ 5 d og 5 e" }, { "date": "2025-11-27", "kind": "applies", "title": "Commission Decision (EU) 2025/2371 published: Eudamed clock starts", "summary": "The Commission confirmed in the Official Journal that the Eudamed systems for registration of economic operators (Article 27), the UDI database and device registration (Articles 25 and 26), notified bodies and certificates (Article 52) and market surveillance (Article 95) are functional and meet the functional specifications, starting the 6-month period of Article 113(3), point (f), and the follow-on periods of points (fa) and (fb).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1 and Art. 2" }, { "date": "2025-09-26", "kind": "applies", "title": "Written agreement with a notified body required for class D and certificate legacy devices", "summary": "Class D legacy devices and devices with a directive certificate may stay on the market beyond this date only if the notified body and the manufacturer have signed the written agreement under Section 4.3 of Annex VII; from this date that notified body is responsible for the surveillance of the devices covered.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(3c), point (f)(i), and Art. 110(3e)" }, { "date": "2025-05-26", "kind": "applies", "title": "UDI carrier on class B and C labels; quality management system and class D application deadline for legacy devices", "summary": "From this date the UDI carrier must appear on the labels and packaging of class B and class C devices; to benefit from the extended transition, legacy-device manufacturers had to have a quality management system under Article 10(8) in place, and class D and certificate devices a formal notified-body application lodged, by this date.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), point (e), and Art. 110(3c), points (d) and (e)(i)" }, { "date": "2025-01-10", "kind": "applies", "title": "Supply-interruption notice under Article 10a applies", "summary": "Manufacturers must inform the competent authority of the Member State where they or their authorised representative are established, and the operators, health institutions and healthcare professionals they supply directly, at least 6 months before an anticipated interruption or discontinuation of supply that could cause serious harm; operators pass the information down the chain, and the duty also covers legacy devices.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 2, point (1), and Art. 3; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 10a and Art. 110(11)" }, { "date": "2024-07-09", "kind": "amendment", "title": "Regulation (EU) 2024/1860 in force: transition to 2027, 2028 and 2029, gradual Eudamed roll-out and supply-interruption notice", "summary": "The regulation of 13 June 2024 inserts Article 10a, applicable from 10 January 2025, rewrites Article 110(2) and (3) so that directive certificates remain valid until 31 December 2027 and legacy devices may be placed on the market until 31 December 2027, 2028 or 2029 by class subject to the Article 110(3c) conditions, lets each Eudamed module become mandatory 6 months after its own functionality notice with 6- and 12-month deadlines for entering existing devices and certificates, adapts the coordinated assessment of performance studies, deletes Article 110(8), aligns the repeal of the directive's registration and vigilance provisions with the module dates and defers Article 5(5), point (d), to 31 December 2030.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 2 and Art. 3" }, { "date": "2024-05-26", "kind": "applies", "title": "In-house device conditions apply", "summary": "Article 5(5), points (b), (c) and (e) to (i), apply to health institutions making their own devices: quality management system, EN ISO 15189 laboratory, information to the competent authority on request, public declaration, class D documentation, manufacture to the documentation and review of clinical experience; point (a), no transfer to another legal entity, has applied since 26 May 2022.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 5(5) and Art. 113(3), point (i)" }, { "date": "2023-05-26", "kind": "applies", "title": "UDI carrier on class D labels", "summary": "From this date the UDI carrier must appear on the label and all higher packaging levels of class D devices, the first step of the class-based schedule of Article 113(3), point (e).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 24(4) and Art. 113(3), point (e)" }, { "date": "2023-03-20", "kind": "amendment", "title": "Regulation (EU) 2023/607 in force: sell-off deadline removed", "summary": "Published and in force on 20 March 2023, the regulation replaces Article 110(4) so that devices lawfully placed on the market under Directive 98/79/EC before 26 May 2022 or under the transitional provisions afterwards may continue to be made available or put into service without time limit, and aligns the second paragraph of Article 112.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607 · Art. 2 and Art. 3" }, { "date": "2023-03-11", "kind": "amendment", "title": "Delegated Regulation (EU) 2023/503 in force: notified-body re-assessment every 5 years", "summary": "Article 40(10) now provides for a complete re-assessment of each notified body 5 years after notification and every 5 years thereafter, with earlier re-assessment on request or where the annual assessments raise concerns, so that authorities and notified bodies can focus on certification during the transitional period.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0503 · Art. 1 and Art. 2" }, { "date": "2022-05-26", "kind": "applies", "title": "IVDR applies; Directive 98/79/EC repealed", "summary": "The regulation applies in full from this date, notifications of notified bodies under the directive become void, and the directive is repealed subject to the transitional provisions and to the directive-based vigilance, performance-study, registration and certificate-notification provisions that survive until the matching Eudamed modules apply.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 110(1), Art. 112 and Art. 113(2)" }, { "date": "2022-01-28", "kind": "amendment", "title": "Regulation (EU) 2022/112 in force: staggered transition and in-house conditions deferred", "summary": "Adopted on 25 January 2022 and in force on the day of publication, the regulation keeps the date of application of 26 May 2022 but extends directive certificates to 27 May 2025, lets certificate devices stay on the market until 26 May 2025 and gives devices that need a notified body for the first time until 26 May 2025 (class D), 26 May 2026 (class C) or 26 May 2027 (class B and sterile class A), with sell-off dates a year later, and defers the Article 5(5) in-house conditions to 26 May 2024 and, for the no-equivalent-device condition, 26 May 2028.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0112 · Art. 1 and Art. 2" }, { "date": "2017-11-26", "kind": "applies", "title": "Notified-body and competent-authority provisions apply", "summary": "Articles 31 to 46 on the designation and oversight of notified bodies and Article 96 on competent authorities apply from this date, ahead of the general date of application; Article 97 on cooperation followed on 26 May 2018 and Article 100 on EU reference laboratories on 25 November 2020.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 · Art. 113(3), points (b), (c) and (d)" }, { "date": "2017-05-25", "kind": "in-force", "title": "Regulation (EU) 2017/746 enters into force", "summary": "Adopted on 5 April 2017 and published in OJ L 117 on 5 May 2017, the regulation entered into force on the twentieth day after publication, with a five-year transition to the date of application of 26 May 2022.", "source": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32017R0746 · Art. 113(1) and (2)" } ], "sources": [ { "label": "Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text of 10 January 2025 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110" }, { "label": "Regulation (EU) 2017/746 as published in OJ L 117, 5 May 2017 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746" }, { "label": "Document information, dates and relationships for CELEX 32017R0746 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32017R0746" }, { "label": "Regulation (EU) 2022/112 on transitional provisions and the deferred application of conditions for in-house devices (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0112" }, { "label": "Commission Delegated Regulation (EU) 2023/503 on the frequency of complete re-assessments of notified bodies (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0503" }, { "label": "Regulation (EU) 2023/607 removing the sell-off deadline for legacy devices (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607" }, { "label": "Regulation (EU) 2024/1860 on the gradual roll-out of Eudamed, the supply-interruption notice and the IVDR transitional provisions (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860" }, { "label": "Commission Decision (EU) 2025/2371 on the functionality of the first four Eudamed electronic systems (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371" }, { "label": "Regulation (EU) 2024/568 on fees payable to the European Medicines Agency, including the companion-diagnostic consultation fee (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0568" }, { "label": "Medical devices, new regulations: overview (European Commission, DG SANTE)", "url": "https://health.ec.europa.eu/medical-devices-new-regulations/overview_en" }, { "label": "Getting ready for the new regulations, IVDR transition timeline and factsheets (European Commission, DG SANTE)", "url": "https://health.ec.europa.eu/medical-devices-new-regulations/getting-ready-new-regulations_en" }, { "label": "EUDAMED overview and mandatory-use timeline (European Commission, DG SANTE)", "url": "https://health.ec.europa.eu/medical-devices-eudamed/overview_en" }, { "label": "MDCG endorsed guidance documents, including MDCG 2020-16 on IVD classification, MDCG 2022-8 on legacy devices and MDCG 2023-1 on in-house devices (European Commission, DG SANTE)", "url": "https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en" }, { "label": "Proposal COM(2025) 1023 of 16 December 2025 to simplify the rules on medical devices and in vitro diagnostics (European Commission)", "url": "https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en" }, { "label": "Medicinsk udstyr (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/" }, { "label": "EU-regler om medicinsk udstyr, including the IVD regulation (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/eu-regler-om-medicinsk-udstyr/" }, { "label": "Forlænget overgangsordning for IVD-udstyr (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/eu-regler-om-medicinsk-udstyr/forlaenget-overgangsordning-for-ivd-udstyr/" }, { "label": "Registrering af virksomheder, Eudamed and Lægemiddelstyrelsen's database (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/registrering/" }, { "label": "Registrering i Eudamed from 28 May 2026 (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/" }, { "label": "Registrering af distributører og specialforretninger (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-af-distributoer-og-specialforretning/" }, { "label": "Gebyrer for medicinsk udstyr (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/gebyrer/" }, { "label": "Indberetning af hændelser (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/indberetning-af-haendelser/" }, { "label": "Forsyningsafbrydelse eller forsyningsophør af medicinsk udstyr (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/forsyningsafbrydelse-eller-forsyningsophoer-af-medicinsk-udstyr/" }, { "label": "Lovgivning for medicinsk udstyr, Danish acts and executive orders (Lægemiddelstyrelsen)", "url": "https://laegemiddelstyrelsen.dk/da/udstyr/lovgivning-og-vejledning/lovgivning/" }, { "label": "Regulation (EU) 2023/1230 on machinery, consolidated text of 27 July 2026, Article 51 repealing Directive 2006/42/EC from 20 January 2027 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1230-20260727" }, { "label": "Lov om medicinsk udstyr, lovbekendtgørelse nr. 682 af 29. maj 2023 (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2023/682" }, { "label": "Lov nr. 1759 af 29. december 2025 om ændring af lov om medicinsk udstyr (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2025/1759" }, { "label": "Bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2025/1731" }, { "label": "Bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr m.v. (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2025/1733" }, { "label": "Bekendtgørelse nr. 839 af 20. juni 2023 om gebyrer for medicinsk udstyr m.v. (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2023/839" } ], "reviewer": { "name": "Conphora compliance team", "role": "Compliance editors, Conphora" }, "reviewedAt": "2026-09-24", "nextReview": "2027-03-12", "links": { "tools": [], "courses": [], "related": { "en": "/regulations/ivdr/", "dk": "/dk/eu-regulativer/ivdr/" } } }