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), or the consolidated text of 10 January 2025 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 · See plans and pricing
Sources
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text of 10 January 2025 (EUR-Lex)
- Regulation (EU) 2017/746 as published in OJ L 117, 5 May 2017 (EUR-Lex)
- Regulation (EU) 2022/112 on transitional provisions and in-house devices (EUR-Lex)
- Commission Delegated Regulation (EU) 2023/503 on notified-body re-assessments (EUR-Lex)
- Regulation (EU) 2023/607 removing the sell-off deadline (EUR-Lex)
- Regulation (EU) 2024/1860 on the gradual roll-out of Eudamed, Article 10a and the IVDR transition (EUR-Lex)
- Commission Decision (EU) 2025/2371 on the functionality of the first four Eudamed modules (EUR-Lex)
- EUDAMED overview and mandatory-use timeline (European Commission)
- MDCG endorsed guidance documents (European Commission)
- Proposal COM(2025) 1023 to simplify the rules on medical devices and IVDs (European Commission)
- Medicinsk udstyr, registrering, gebyrer, overgangsordning for IVD-udstyr og lovgivning (Lægemiddelstyrelsen)
- Regulation (EU) 2023/1230 on machinery, consolidated text of 27 July 2026 (EUR-Lex)
- Lov om medicinsk udstyr, lovbekendtgørelse nr. 682 af 29. maj 2023 (Retsinformation)
- Lov nr. 1759 af 29. december 2025 om ændring af lov om medicinsk udstyr (Retsinformation)
- Bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (Retsinformation)
- Bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr m.v. (Retsinformation)
- Bekendtgørelse nr. 839 af 20. juni 2023 om gebyrer for medicinsk udstyr m.v. (Retsinformation)
This guide is for general information and is not legal advice.