--- title: "IVDR — In Vitro Diagnostic Medical Devices Regulation" description: "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." type: "guide" url: "https://www.conphora.com/regulations/ivdr/" markdown: "https://www.conphora.com/regulations/ivdr.md" locale: "en" language: "en" published: "2017-05-25" updated: "2026-09-12" author: "Conphora compliance team" publisher: "Conphora" reference: "Regulation (EU) 2017/746" celex: "32017R0746" source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746" tags: ["IVDR", "Medical Devices"] license: "Free to quote with attribution and a link to the page" --- # IVDR — In Vitro Diagnostic Medical Devices Regulation 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. ## Key facts - **Official title:** 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 - **Reference:** Regulation (EU) 2017/746 - **CELEX:** 32017R0746 - **Act type:** Regulation - **In force:** 2017-05-25 - **Applies from:** 2022-05-26 - **Enforced by:** 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. - **Category:** Medical Devices ## Who it applies to **Covered by the act:** 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 and downstream products:** 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)) **Roles under the act:** - **Manufacturer (including own-brand sellers and persons who change or modify a device)** — 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. - **Authorised representative** — 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. - **Importer** — Any natural or legal person established within the Union that places a device from a third country on the Union market. - **Distributor (wholesaler, pharmacy, laboratory supplier, retailer)** — 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. ## Key dates - 2017-04-05: Regulation (EU) 2017/746 adopted by the European Parliament and the Council in Strasbourg; published in OJ L 117 on 5 May 2017 - 2017-05-25: Entry into force, the twentieth day after publication in the Official Journal - 2017-11-26: 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 - 2018-05-26: Article 97 on cooperation between Member States applies - 2019-05-26: GS1, HIBCC and ICCBBA are deemed designated UDI issuing entities until the Commission designates entities under Article 24(2) - 2020-11-25: Article 100 on the EU reference laboratories for class D devices applies - 2022-01-28: 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 - 2022-05-26: The regulation applies; Directive 98/79/EC is repealed subject to the transitional provisions and notifications of notified bodies under it become void - 2023-03-11: 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 - 2023-03-20: 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 - 2023-05-26: UDI carrier required on the label and all higher packaging levels of class D devices - 2024-05-26: 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 - 2024-07-09: 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 - 2025-01-10: Article 10a applies: manufacturers must give at least 6 months' notice of an anticipated interruption or discontinuation of supply that could cause serious harm - 2025-05-26: 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 - 2025-05-27: Certificates issued under Annex VI to Directive 98/79/EC (EC verification) become void at the latest - 2025-09-26: 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 - 2025-11-27: 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) - 2026-05-26: Deadline for class C legacy devices to have a formal application lodged with a notified body - 2026-05-28: 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 - 2026-09-26: Deadline for the written agreement between the manufacturer and a notified body for class C legacy devices - 2026-11-28: 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) - 2027-05-26: 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 - 2027-05-27: 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 - 2027-05-28: 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) - 2027-09-26: Deadline for the written agreement between the manufacturer and a notified body for class B and sterile class A legacy devices - 2027-12-31: 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 - 2028-12-31: End of the transitional period for class C legacy devices - 2029-12-31: End of the transitional period for class B legacy devices and class A devices placed on the market in sterile condition - 2030-12-31: 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 ## What you must do ### Manufacturer (including own-brand sellers and persons who change or modify a device) - 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. - 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. - Establish, document, implement and maintain a risk management system for the device, as a continuous process throughout its lifecycle. - 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. - 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. - Classify the device into class A, B, C or D using the seven classification rules and the implementing rules of Annex VIII. - 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. - 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. - Draw up and keep up to date the technical documentation of Annexes II and III, including the post-market surveillance documentation. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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 your Eudamed actor data within one week of any change, and confirm its accuracy one year after registration and every second year thereafter. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. ### Authorised representative - 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). - 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. - 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. - 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. - 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. - Register in Eudamed to obtain your own single registration number, and keep your actor data updated and confirmed. - Verify that the manufacturer has complied with its registration obligations for the device and for itself. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. ### Importer - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - 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. - Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and its authorised representative. - 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. - 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. - 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. - 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. - 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. ### Distributor (wholesaler, pharmacy, laboratory supplier, retailer) - 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. - 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. - 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. - 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. - 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. - Keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep the manufacturer, authorised representative and importer informed of that monitoring. - 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. - 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. - 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. - 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. - 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. - 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. - 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). ## Requirements Each duty above as an identified requirement (64); ids are permanent and shared with the compliance engine. ### evidence - `ivdr-mfr-design-to-annex-i` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [Art. 5(2) and Art. 10(1)] - `ivdr-mfr-conduct-performance-evaluation` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [Art. 5(3), Art. 10(3) and Art. 56] - `ivdr-mfr-draw-technical-documentation` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — Draw up and keep up to date the technical documentation of Annexes II and III, including the post-market surveillance documentation. [Art. 10(4)] - `ivdr-mfr-draw-eu-declaration` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [Art. 10(5) and Art. 17] - `ivdr-mfr-supply-label-ifu` (Manufacturer (including own-brand sellers and persons who change or modify a device), product-market, before-market) — 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. [Art. 10(10)] - `ivdr-mfr-draw-safety-performance-summary` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [Art. 29] - `ivdr-mfr-produce-pms-report-psur` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, periodic) — 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. [Art. 80 and Art. 81] - `ivdr-mfr-designate-authorised-representative` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, before-market) — 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. [Art. 10(7), third subparagraph, and Art. 11(1)] - `ivdr-oth-accept-written-mandate` (Authorised representative, company, before-market) — 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). [Art. 11(2) to (4)] - `ivdr-oth-forward-complaints-manufacturer` (Authorised representative, product, on-event) — 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. [Art. 11(3), point (g)] - `ivdr-oth-agree-change-representative` (Authorised representative, company, on-event) — 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. [Art. 12] - `ivdr-imp-forward-complaints` (Importer, product, on-event) — Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and its authorised representative. [Art. 13(8)] - `ivdr-dist-forward-complaints` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), product, on-event) — 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. [Art. 14(5)] ### data - `ivdr-mfr-assign-udi-carrier` (Manufacturer (including own-brand sellers and persons who change or modify a device), unit, before-market) — 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. [Art. 24(1), (3), (4) and (7) and Art. 113(3), point (e)] ### mark - `ivdr-mfr-affix-ce-marking` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [Art. 10(5) and Art. 18] - `ivdr-imp-indicate-name-address` (Importer, product, before-market) — 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. [Art. 13(3)] ### decision - `ivdr-mfr-classify-device` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — Classify the device into class A, B, C or D using the seven classification rules and the implementing rules of Annex VIII. [Art. 47(1) and Annex VIII] ### procedure - `ivdr-mfr-run-risk-management` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — Establish, document, implement and maintain a risk management system for the device, as a continuous process throughout its lifecycle. [Art. 10(2)] - `ivdr-mfr-run-conformity-assessment` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [Art. 48(1) to (10)] - `ivdr-mfr-run-pms-system` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, ongoing) — 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. [Art. 10(9), Art. 78 and Art. 79] - `ivdr-imp-relabel-repackage-conditions` (Importer, product, before-market) — 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. [Art. 16(2) to (4)] - `ivdr-dist-relabel-repackage-conditions` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), product, before-market) — 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. [Art. 16(2) to (4)] ### submission - `ivdr-mfr-submit-udi-database` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [Art. 26(1) and (2)] - `ivdr-mfr-register-actor-srn` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, before-market) — 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. [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] - `ivdr-mfr-confirm-actor-data` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, periodic) — Update your Eudamed actor data within one week of any change, and confirm its accuracy one year after registration and every second year thereafter. [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] - `ivdr-mfr-register-devices-eudamed` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, before-market) — 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. [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] - `ivdr-mfr-report-serious-incident` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, on-event) — 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. [Art. 10(12), Art. 82(1)(a) and (3) to (5) and Art. 84] - `ivdr-mfr-report-field-safety-action` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, on-event) — 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. [Art. 82(1)(b) and Art. 84(8)] - `ivdr-mfr-submit-trend-reports` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, on-event) — 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. [Art. 83] - `ivdr-mfr-take-corrective-action` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, on-event) — 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. [Art. 10(11)] - `ivdr-mfr-give-competent-authority` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, on-event) — 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. [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/] - `ivdr-oth-register-actor-srn` (Authorised representative, company, before-market) — Register in Eudamed to obtain your own single registration number, and keep your actor data updated and confirmed. [Art. 28] - `ivdr-oth-terminate-mandate-breach` (Authorised representative, company, on-event) — 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. [Art. 11(3), point (h), and Art. 11(6)] - `ivdr-imp-register-actor-srn` (Importer, company, before-market) — 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. [Art. 28; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/] - `ivdr-imp-inform-nonconformity` (Importer, product, on-event) — 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. [Art. 13(7)] - `ivdr-dist-immediately-inform-manufacturer` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), product, on-event) — 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. [Art. 14(4)] - `ivdr-dist-register-distributor-denmark` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), company, before-market) — 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). [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/] ### verification - `ivdr-oth-verify-declaration-documentation` (Authorised representative, product, ongoing) — 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. [Art. 11(3), point (a)] - `ivdr-oth-verify-manufacturer-registration` (Authorised representative, product, before-market) — Verify that the manufacturer has complied with its registration obligations for the device and for itself. [Art. 11(3), point (c)] - `ivdr-imp-place-conforming-devices` (Importer, product, before-market) — 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. [Art. 13(1) and (2)] - `ivdr-imp-verify-device-registration` (Importer, product, before-market) — 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. [Art. 13(4) and Art. 27(3)] - `ivdr-dist-act-due-care` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), product, before-market) — 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. [Art. 14(1) and (2)] ### standing - `ivdr-mfr-keep-documentation-years` (Manufacturer (including own-brand sellers and persons who change or modify a device), product, ongoing) — 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. [Art. 10(7)] - `ivdr-mfr-operate-qms` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, ongoing) — 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. [Art. 10(8)] - `ivdr-mfr-appoint-prrc` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, ongoing) — 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. [Art. 15(1) to (3)] - `ivdr-mfr-avoid-misleading-claims` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, ongoing) — 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. [Art. 7] - `ivdr-mfr-provide-information-request` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, ongoing) — 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. [Art. 10(13)] - `ivdr-mfr-hold-liability-coverage` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, ongoing) — 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. [Art. 10(15)] - `ivdr-mfr-comply-distance-sales` (Manufacturer (including own-brand sellers and persons who change or modify a device), company, ongoing) — 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. [Art. 6] - `ivdr-oth-keep-documentation-copy` (Authorised representative, product, ongoing) — 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. [Art. 11(3), point (b), and Art. 10(7)] - `ivdr-oth-provide-competent-authority` (Authorised representative, company, ongoing) — 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. [Art. 11(3), points (d) to (f)] - `ivdr-oth-have-permanently-continuously` (Authorised representative, company, ongoing) — 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. [Art. 15(6)] - `ivdr-imp-ensure-storage-transport` (Importer, company, ongoing) — 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. [Art. 13(5)] - `ivdr-imp-keep-complaints-register` (Importer, company, ongoing) — 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. [Art. 13(6)] - `ivdr-imp-keep-declaration-copy` (Importer, product, ongoing) — 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. [Art. 13(9)] - `ivdr-imp-cooperate-provide-samples` (Importer, company, ongoing) — 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. [Art. 13(10)] - `ivdr-imp-identify-supply-chain` (Importer, company, ongoing) — 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. [Art. 22] - `ivdr-dist-keep-storage-transport` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), company, ongoing) — 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. [Art. 14(3)] - `ivdr-dist-keep-complaints-register` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), company, ongoing) — Keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep the manufacturer, authorised representative and importer informed of that monitoring. [Art. 14(5)] - `ivdr-dist-provide-information-request` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), company, ongoing) — 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. [Art. 14(6)] - `ivdr-dist-identify-supply-chain` (Distributor (wholesaler, pharmacy, laboratory supplier, retailer), company, ongoing) — 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. [Art. 22] ## Penalties 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)). ## Checklist 1. 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)). 2. 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). 3. 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)). 4. 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). 5. 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). 6. 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. 7. 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)). 8. 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). 9. 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). 10. 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)). ## Questions ### When did the IVDR start to apply? 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. ### Until when can legacy devices with a directive certificate or declaration still be placed on the market? 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. ### Which class is my test in, and do I need a notified body? 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. ### When does Eudamed become mandatory for IVDs? 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. ### Can a hospital laboratory keep using its own in-house tests? 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. ### How quickly must serious incidents be reported? 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). ### What must an importer or distributor in Denmark do beyond the EU rules? 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. ## What changed - 2030-12-31 (applies): **In-house devices: the no-equivalent-device condition applies** — 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. - 2029-12-31 (applies): **Transitional period ends for class B and sterile class A legacy devices** — 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. - 2028-12-31 (applies): **Transitional period ends for class C legacy devices** — 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. - 2027-12-31 (applies): **Transitional period ends for class D legacy devices and all directive certificates** — 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. - 2027-05-28 (applies): **Notified-body certificates must be in Eudamed** — 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. - 2027-05-26 (applies): **UDI carrier on class A labels; notified-body application deadline for class B and sterile class A legacy devices** — 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. - 2026-11-28 (applies): **Device registration backlog must be entered in Eudamed** — 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. - 2026-09-12 (guidance): **Guide rebuilt from the consolidated text of 10 January 2025** — 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. - 2026-05-28 (applies): **Eudamed mandatory for actors, devices, certificates and market surveillance** — 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. - 2026-05-26 (applies): **Notified-body application deadline for class C legacy devices** — 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. - 2025-12-29 (amendment): **Denmark: stock and consumption reporting and a state preparedness scheme for medical devices** — 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. - 2025-11-27 (applies): **Commission Decision (EU) 2025/2371 published: Eudamed clock starts** — 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). - 2025-09-26 (applies): **Written agreement with a notified body required for class D and certificate legacy devices** — 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. - 2025-05-26 (applies): **UDI carrier on class B and C labels; quality management system and class D application deadline for legacy devices** — 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. - 2025-01-10 (applies): **Supply-interruption notice under Article 10a applies** — 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. - 2024-07-09 (amendment): **Regulation (EU) 2024/1860 in force: transition to 2027, 2028 and 2029, gradual Eudamed roll-out and supply-interruption notice** — 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. - 2024-05-26 (applies): **In-house device conditions apply** — 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. - 2023-05-26 (applies): **UDI carrier on class D labels** — 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). - 2023-03-20 (amendment): **Regulation (EU) 2023/607 in force: sell-off deadline removed** — 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. - 2023-03-11 (amendment): **Delegated Regulation (EU) 2023/503 in force: notified-body re-assessment every 5 years** — 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. - 2022-05-26 (applies): **IVDR applies; Directive 98/79/EC repealed** — 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. - 2022-01-28 (amendment): **Regulation (EU) 2022/112 in force: staggered transition and in-house conditions deferred** — 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. - 2017-11-26 (applies): **Notified-body and competent-authority provisions apply** — 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. - 2017-05-25 (in-force): **Regulation (EU) 2017/746 enters into force** — 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. ## IVDR in plain terms The In Vitro Diagnostic Medical Devices Regulation (IVDR), formally Regulation (EU) 2017/746, is the EU's single rulebook for placing in vitro diagnostic medical devices for human use and their accessories on the market, making them available and putting them into service, and for the performance studies conducted on them in the Union (Art. 1(1)). It replaced the In Vitro Diagnostic Medical Devices Directive 98/79/EC on 26 May 2022 (Art. 112 and Art. 113(2)) and, as a regulation, applies directly in every Member State without national transposition. Its architecture mirrors the Medical Devices Regulation (MDR), its sister act for all other medical devices: general safety and performance requirements in Annex I, a performance evaluation for every device, risk classification into classes A, B, C and D, a conformity assessment by a notified body for everything above non-sterile class A, the EU declaration of conformity and CE marking, and then a lifetime of post-market surveillance, vigilance and traceability through the Unique Device Identifier and the European database Eudamed. The step change from the directive is who needs a notified body. Under Directive 98/79/EC most diagnostics were self-certified; under the IVDR only non-sterile class A devices are, and every class B, C and D device, from a pregnancy test to a hepatitis assay, involves a notified body (Art. 48). Because notified-body capacity did not keep pace, the transition was extended three times: Regulation (EU) 2022/112 staggered it by class, Regulation (EU) 2023/607 removed the sell-off deadline, and Regulation (EU) 2024/1860 gave legacy devices until 31 December 2027, 2028 or 2029 depending on class, subject to conditions (Art. 110). The same regulation let Eudamed go live module by module; after Commission Decision (EU) 2025/2371 the first four modules are mandatory from 28 May 2026. > **Official text** > Read the regulation on EUR-Lex: [Regulation (EU) 2017/746 (CELEX 32017R0746)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746), or the [consolidated text of 10 January 2025](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110) that includes the staggered transition, the removal of the sell-off deadline, the Eudamed roll-out and Article 10a. ## Scope An in vitro diagnostic medical device is any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, used alone or in combination, that the manufacturer intends to be used in vitro for the examination of specimens derived from the human body, including blood and tissue donations, solely or principally to provide information on a physiological or pathological process or state, on congenital physical or mental impairments, on the predisposition to a medical condition or disease, to determine the safety and compatibility with potential recipients, to predict treatment response or reactions, or to define or monitor therapeutic measures (Art. 2, point (2)). Specimen receptacles are deemed IVDs, and accessories are covered in their own right (Art. 2, points (3) and (4)). The regulation names three special groups: devices for self-testing by lay persons, devices for near-patient testing outside a laboratory by a health professional, and companion diagnostics that are essential for the safe and effective use of a medicinal product (Art. 2, points (5) to (7)). Devices offered online to persons in the Union, and devices used to provide a diagnostic service at a distance, must comply too (Art. 6). Article 1(3) lists what is excluded: products for general laboratory use and research-use-only products, unless the manufacturer specifically intends them for in vitro diagnostic examination; invasive sampling products and products applied directly to the body to obtain a specimen; internationally certified reference materials; and materials used for external quality assessment schemes. A device that incorporates a medical device as an integral part is governed by the MDR, with the IVDR applying to the IVD part (Art. 1(4)). 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 Annex I to Directive 2006/42/EC (Art. 1(5) and (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. Devices made and used only within a health institution are exempt from everything except the relevant Annex I requirements, provided the nine conditions of Article 5(5) are met and manufacture is not on an industrial scale; the conditions apply since 26 May 2024, except the requirement to document that no equivalent CE-marked device meets the need, which applies from 31 December 2030 (Art. 113(3), points (i) and (j)). The duties fall on the economic operators: the manufacturer, the authorised representative, the importer and the distributor (Art. 2, points (23) to (28)). A distributor, importer or other person that makes a device available under its own name or trade mark, changes its intended purpose or modifies it in a way that may affect compliance assumes the manufacturer's obligations (Art. 16(1)). A manufacturer established outside the Union may place devices on the market only through a sole authorised representative (Art. 11(1)). ## What you must do ### Classification and conformity assessment Devices are divided into classes A, B, C and D according to their intended purpose and inherent risks, using Annex VIII (Art. 47(1)). The annex has ten implementing rules and seven classification rules. Rule 1 puts tests for transmissible agents in blood, blood components, cells, tissues or organs intended for transfusion, transplantation or cell administration, tests for transmissible agents causing a life-threatening disease with a high or suspected high risk of propagation, and tests for the infectious load of a life-threatening disease in class D. Rule 2 puts blood grouping and tissue typing in class C, except the ABO, Rhesus, Kell, Kidd and Duffy markers, which are class D. Rule 3 lists thirteen class C purposes, from sexually transmitted and other infectious agents, prenatal and newborn screening and companion diagnostics to 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 and cholesterol tests and urine tests for glucose, erythrocytes, leucocytes and bacteria, 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 (Annex VIII, Section 2). Software that drives or influences a device takes its class, independent software is classified on its own, calibrators and controls with assigned values take the class of their device, and where several rules apply the higher class wins (Annex VIII, Sections 1.4 to 1.9). Disputes on classification go to the competent authority of the manufacturer's Member State (Art. 47(2)). The class determines the route under Article 48. Class D manufacturers follow Annex IX Chapters I, II and III, meaning a quality management system audit and an assessment of the technical documentation of every device, or alternatively Annex X type examination with Annex XI production quality assurance; where an EU reference laboratory has been designated under Article 100, the notified body has it verify the claimed performance and compliance with the common specifications by laboratory testing, and where no common specification exists and it is the first certification of that type of device, the notified body consults the expert panel on the performance evaluation report (Art. 48(3) to (6)). Class C manufacturers follow Annex IX Chapters I and III with an assessment of the technical documentation of at least one representative device per generic device group, or Annex X with Annex XI (Art. 48(7) and (8)); class B manufacturers follow Annex IX Chapters I and III with one representative device per category (Art. 48(9)). Class A manufacturers draw up the Annex II and III technical documentation and issue the EU declaration of conformity themselves, unless the device is placed on the market sterile, in which case a notified body checks the sterility aspects under Annex IX or XI (Art. 48(10)). Self-testing and near-patient devices in classes B, C and D additionally undergo the technical-documentation assessment of Section 5.1 of Annex IX, and for companion diagnostics the notified body consults the competent authority for the corresponding medicinal product or the European Medicines Agency under Section 5.2 of Annex IX, for every device in class C (Art. 48(3), (4), (7) and (8)); Regulation (EU) 2024/568 sets the EMA fee for that consultation at EUR 56 500, and EUR 5 000 for a change affecting suitability (Annex IV, point 7.3). Certificates run for at most five years and are renewable (Art. 51(2)). Devices for performance studies follow Articles 57 to 77 instead (Art. 48(11)). ### General requirements, performance evaluation and quality management Every device must meet the general safety and performance requirements of Annex I for its intended purpose: eight general requirements in Chapter I, requirements on performance characteristics, chemical, physical and biological properties, infection, biological materials, construction, measuring function, radiation, software, energy sources, mechanical and thermal risks and self-testing or near-patient devices in Chapter II (Sections 9 to 19), and the label and instructions for use in Chapter III (Section 20). Demonstrating conformity includes a performance evaluation under Article 56 and Annex XIII that establishes the scientific validity of the analyte, the analytical performance and the clinical performance of the device, with clinical performance studies unless reliance on other sources is duly justified; the manufacturer specifies and justifies the level of clinical evidence, documents it in a performance evaluation report that is part of the technical documentation, and updates it throughout the device's life with post-market performance follow-up data, at least annually for class C and D devices (Art. 5(2) and (3), Art. 10(3) and Art. 56). Performance 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, an ethics committee opinion and a sponsor or legal representative in the Union (Art. 58). Manufacturers run a risk management system (Art. 10(2)), a quality management system proportionate to the risk class covering the thirteen elements of Article 10(8), and have a person responsible for regulatory compliance with the qualifications of Article 15; micro and small enterprises may have that person permanently at their disposal rather than on staff (Art. 15(2)). ### Technical documentation, declaration and CE marking The technical documentation of Annexes II and III must allow conformity to be assessed and be kept up to date (Art. 10(4)); the post-market surveillance plan is part of it (Art. 79). The EU declaration of conformity contains at least the Annex IV information and the Basic UDI-DI, is continuously updated, is translated into the languages the Member States require and, where other Union acts also require a declaration, is a single declaration covering all of them (Art. 17 and Art. 24(6)). The CE marking is affixed visibly, legibly and indelibly to the device or its sterile packaging, otherwise to the packaging, and also appears in the instructions for use and on sales packaging, followed by the notified body's identification number where applicable; it follows the general principles of Article 30 of Regulation (EC) No 765/2008, which remains in force (Art. 18). Manufacturers keep the documentation, declaration and certificates for at least 10 years after the last device covered by the declaration was placed on the market; authorised representatives and importers keep copies for the same period (Art. 10(7), Art. 11(3) and Art. 13(9)). Devices for performance studies carry no CE marking (Art. 19(2)). ### UDI, registration and Eudamed Every device other than a device for performance study receives a UDI made of a device identifier (UDI-DI) and a production identifier (UDI-PI), created under the rules of a designated issuing entity; the UDI carrier goes on the label and every higher packaging level, the Basic UDI-DI appears on the declaration of conformity, and the manufacturer keeps a list of all UDIs in the technical documentation (Art. 24). The label dates are staggered by class: 26 May 2023 for class D, 26 May 2025 for classes B and C, 26 May 2027 for class A (Art. 113(3), point (e)). GS1, HIBCC and ICCBBA are the issuing entities until the Commission designates others (Art. 110(10)). Manufacturers, authorised representatives and importers register in Eudamed and receive a single registration number (SRN) from their competent authority before placing a device on the market and before applying to a notified body, update their data within a week of any change and confirm it after one year and every second year (Art. 27 and Art. 28). Manufacturers register each device with its Basic UDI-DI and the Annex VI core data (Art. 26); for class C and D devices they also draw up a summary of safety and performance, validated by the notified body and published in Eudamed (Art. 29). Eudamed comprises seven electronic systems (Art. 30(2)); Regulation (EU) 2024/1860 allowed them to become mandatory one by one, six months after the Commission's functionality notice. Commission Decision (EU) 2025/2371 of 27 November 2025 gave that notice for the actor, UDI and device, certificate and market-surveillance modules, so their use is mandatory from 28 May 2026; devices placed on the market from that date must be entered within a further 6 months and notified bodies must enter their certificates within 12 months (Art. 113(3), points (f) to (fc)). The regulation itself counts six months from the publication of the notice, which was 27 November 2025; the Commission publishes 28 May 2026, and the follow-on deadlines are stated here on the same basis, so a manufacturer that wants certainty should work to 27 May 2026, 27 November 2026 and 27 May 2027. The vigilance and performance-study modules are still under development, and until their notice the directive-era arrangements for vigilance reporting and performance studies continue (Art. 113(3), point (f), second subparagraph). Member States may keep national registration of distributors (Art. 27(2)); Denmark does. ### Information, language and claims The label and instructions for use carry 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; for self-testing and near-patient devices the information must be easily understandable (Art. 10(10)). Misleading claims about intended purpose, safety or performance, including suggesting uses outside the assessed intended purpose, are prohibited in labelling, instructions, making available and advertising (Art. 7). Anyone supplying a spare part that significantly changes a device's performance, safety or intended purpose places a device on the market (Art. 20). ### Post-market surveillance, vigilance and supply Each device has a post-market surveillance system and plan; class A and B manufacturers write a post-market surveillance report, class C and D manufacturers a periodic safety update report updated at least annually, submitted through the electronic system to the notified body for class D and made available to it for class C (Art. 78 to 81). Serious incidents are reported immediately and no later than 15 days after awareness, 2 days for a serious public health threat, 10 days for death or an unanticipated serious deterioration in health; expected erroneous results that are documented and quantified in the product information go into trend reporting instead, field safety corrective actions are reported in advance and communicated to users through field safety notices, and statistically significant increases in non-serious incidents or in expected erroneous results are trend-reported (Art. 82 to 84). Since 10 January 2025 manufacturers must give at least 6 months' notice of an anticipated interruption or discontinuation of supply that could cause serious harm, and every operator passes the information down the chain (Art. 10a). ### Obligations by role Manufacturers carry the design, classification, performance-evaluation, documentation, declaration, marking, UDI, registration, surveillance, vigilance and corrective-action duties (Art. 10). Authorised representatives act under a mandate covering at least the Article 11(3) tasks, keep the documents, register, cooperate with authorities and are jointly liable where a non-EU manufacturer fails its duties (Art. 11). Importers verify the CE marking, declaration, labelling, representative and UDI before placing a device on the market, add their identification, register and add themselves to the device registration, guard storage and transport, keep a complaints register and forward incident reports (Art. 13). Distributors verify the same points before making a device available, keep the manufacturer's storage conditions, forward complaints and incident reports and cooperate on corrective action (Art. 14). Every operator must be able to identify whom it supplied and who supplied it for 10 years (Art. 22). Translating the information or repackaging by importers or distributors requires a certified quality management system and 28 days' notice (Art. 16(2) to (4)). ### In-house devices Health institutions established in the Union may make and use their own tests without CE marking under Article 5(5), which exempts them from everything except the relevant Annex I requirements provided nine conditions are met: no transfer to another legal entity, an appropriate 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 target patient group's needs, information to the competent authority on request, a public declaration identifying the devices and confirming Annex I compliance, documentation of the manufacturing facility, process, design and performance for class D devices (and for other classes where the Member State so decides), manufacture to that documentation, and a review of clinical experience with corrective action. Regulation (EU) 2022/112 deferred the conditions other than the transfer ban to 26 May 2024 and the no-equivalent-device condition to 26 May 2028; Regulation (EU) 2024/1860 moved the latter to 31 December 2030 (Art. 113(3), points (i) and (j)). Industrial-scale manufacture is never covered, and Member States may restrict specific device types and inspect the institution. ### Legacy devices until 2027, 2028 and 2029 Certificates issued under the directive from 25 May 2017 that were still valid on 26 May 2022 remain valid until 31 December 2027, and devices covered by them may be placed on the market or put into service until that date; certificates that expired before 9 July 2024 count as valid only if a written agreement with a notified body was signed before expiry or a competent authority granted an Article 54 derogation or required the assessment (Art. 110(2) and (3a)). Devices that needed no notified body under the directive, with a directive declaration of conformity drawn up before 26 May 2022, and that now need one, 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 sterile class A (Art. 110(3b)). 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 (class D and certificate devices), 26 May 2026 (class C) or 26 May 2027 (class B and sterile class A), and a written agreement by 26 September of the same years (Art. 110(3c)). The IVDR rules on post-market surveillance, market surveillance, vigilance and registration, and the Article 10a supply-interruption notice, already apply to these devices (Art. 110(3d) and (11)), the notified body that signed the agreement took over their surveillance by 26 September 2025 (Art. 110(3e)), and devices lawfully placed on the market may continue to be made available without a sell-off deadline (Art. 110(4)). The Commission's MDCG 2022-8 and MDCG 2022-6 guidance covers the application of the regulation to legacy devices and what counts as a significant change. ### What may change: the December 2025 proposal On 16 December 2025 the Commission adopted proposal COM(2025) 1023 for a regulation amending the MDR and the IVDR to simplify and reduce the burden of the rules on medical devices and in vitro diagnostic medical devices. It is a proposal under the ordinary legislative procedure and not yet law; nothing on this page relies on it. ## Enforcement and penalties The regulation carries its own market-surveillance chapter. Competent authorities check devices through documentation reviews, physical and laboratory checks and announced or unannounced inspections of economic operators, suppliers and subcontractors, may demand documentation, information and free samples, and may confiscate, destroy or render inoperable devices presenting an unacceptable risk or falsified devices (Art. 88). 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 its making available, withdraw or recall it and notify the Commission and the other Member States, which then take corresponding measures unless the Commission finds the measure unjustified (Art. 90 and Art. 91). Other non-compliance must be ended within a set period, otherwise the same measures follow (Art. 92), and a Member State may take preventive health-protection measures against a category of devices (Art. 93). A manufacturer that does not cooperate or supplies incomplete information can see its device prohibited, restricted, withdrawn or recalled until it complies (Art. 10(13)). The CE marking follows the general principles of Article 30 of Regulation (EC) No 765/2008, which remains in force (Art. 18(2)). Penalties are national: Member States lay down effective, proportionate and dissuasive penalties and notified them to the Commission by 25 February 2022 (Art. 106). In Denmark, Lægemiddelstyrelsen (the Danish Medicines Agency) supervises manufacturers and the other operators, receives incident and supply-interruption reports, verifies the Eudamed actor registrations that lead to the single registration number and registers Danish distributors and specialist retailers of IVDs. The Danish framework is lov om medicinsk udstyr, lovbekendtgørelse nr. 682 af 29. maj 2023, as amended by lov nr. 1759 of 29 December 2025, 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), which covers both medical devices and IVDs, and the fee orders 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 (manufacturers and authorised representatives) 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) (importers and distributors); 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)). ## How Conphora helps Conphora monitors the IVDR, its amending acts and the Eudamed timeline and maps your devices against the class-specific route, the performance-evaluation and documentation duties, the UDI and registration obligations and the vigilance clocks, flagging gaps before a notified body or Lægemiddelstyrelsen does. The platform keeps your declaration of conformity, certificates and 10-year records in one place and alerts you when a date moves, from the Eudamed backlog deadline to the legacy cut-offs of 31 December 2027, 2028 and 2029. [See how Conphora works](/how-it-works) · [See plans and pricing](/pricing) ## Sources - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text of 10 January 2025 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110) - [Regulation (EU) 2017/746 as published in OJ L 117, 5 May 2017 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746) - [Regulation (EU) 2022/112 on transitional provisions and in-house devices (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0112) - [Commission Delegated Regulation (EU) 2023/503 on notified-body re-assessments (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0503) - [Regulation (EU) 2023/607 removing the sell-off deadline (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607) - [Regulation (EU) 2024/1860 on the gradual roll-out of Eudamed, Article 10a and the IVDR transition (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860) - [Commission Decision (EU) 2025/2371 on the functionality of the first four Eudamed modules (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371) - [EUDAMED overview and mandatory-use timeline (European Commission)](https://health.ec.europa.eu/medical-devices-eudamed/overview_en) - [MDCG endorsed guidance documents (European Commission)](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) - [Proposal COM(2025) 1023 to simplify the rules on medical devices and IVDs (European Commission)](https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en) - [Medicinsk udstyr, registrering, gebyrer, overgangsordning for IVD-udstyr og lovgivning (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/) - [Regulation (EU) 2023/1230 on machinery, consolidated text of 27 July 2026 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1230-20260727) - [Lov om medicinsk udstyr, lovbekendtgørelse nr. 682 af 29. maj 2023 (Retsinformation)](https://www.retsinformation.dk/eli/lta/2023/682) - [Lov nr. 1759 af 29. december 2025 om ændring af lov om medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1759) - [Bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1731) - [Bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1733) - [Bekendtgørelse nr. 839 af 20. juni 2023 om gebyrer for medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2023/839) *This guide is for general information and is not legal advice.* ## Sources - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text of 10 January 2025 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110) - [Regulation (EU) 2017/746 as published in OJ L 117, 5 May 2017 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746) - [Document information, dates and relationships for CELEX 32017R0746 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32017R0746) - [Regulation (EU) 2022/112 on transitional provisions and the deferred application of conditions for in-house devices (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0112) - [Commission Delegated Regulation (EU) 2023/503 on the frequency of complete re-assessments of notified bodies (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0503) - [Regulation (EU) 2023/607 removing the sell-off deadline for legacy devices (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607) - [Regulation (EU) 2024/1860 on the gradual roll-out of Eudamed, the supply-interruption notice and the IVDR transitional provisions (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860) - [Commission Decision (EU) 2025/2371 on the functionality of the first four Eudamed electronic systems (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371) - [Regulation (EU) 2024/568 on fees payable to the European Medicines Agency, including the companion-diagnostic consultation fee (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0568) - [Medical devices, new regulations: overview (European Commission, DG SANTE)](https://health.ec.europa.eu/medical-devices-new-regulations/overview_en) - [Getting ready for the new regulations, IVDR transition timeline and factsheets (European Commission, DG SANTE)](https://health.ec.europa.eu/medical-devices-new-regulations/getting-ready-new-regulations_en) - [EUDAMED overview and mandatory-use timeline (European Commission, DG SANTE)](https://health.ec.europa.eu/medical-devices-eudamed/overview_en) - [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)](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) - [Proposal COM(2025) 1023 of 16 December 2025 to simplify the rules on medical devices and in vitro diagnostics (European Commission)](https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en) - [Medicinsk udstyr (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/) - [EU-regler om medicinsk udstyr, including the IVD regulation (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/eu-regler-om-medicinsk-udstyr/) - [Forlænget overgangsordning for IVD-udstyr (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/eu-regler-om-medicinsk-udstyr/forlaenget-overgangsordning-for-ivd-udstyr/) - [Registrering af virksomheder, Eudamed and Lægemiddelstyrelsen's database (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/registrering/) - [Registrering i Eudamed from 28 May 2026 (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/) - [Registrering af distributører og specialforretninger (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-af-distributoer-og-specialforretning/) - [Gebyrer for medicinsk udstyr (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/gebyrer/) - [Indberetning af hændelser (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/indberetning-af-haendelser/) - [Forsyningsafbrydelse eller forsyningsophør af medicinsk udstyr (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/forsyningsafbrydelse-eller-forsyningsophoer-af-medicinsk-udstyr/) - [Lovgivning for medicinsk udstyr, Danish acts and executive orders (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/lovgivning-og-vejledning/lovgivning/) - [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)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1230-20260727) - [Lov om medicinsk udstyr, lovbekendtgørelse nr. 682 af 29. maj 2023 (Retsinformation)](https://www.retsinformation.dk/eli/lta/2023/682) - [Lov nr. 1759 af 29. december 2025 om ændring af lov om medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1759) - [Bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1731) - [Bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1733) - [Bekendtgørelse nr. 839 af 20. juni 2023 om gebyrer for medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2023/839) _Reviewed 2026-09-24 by Conphora compliance team_