IVDR (Regulation (EU) 2017/746): What the In Vitro Diagnostic Regulation Requires and When

The regulation replaced Directive 98/79/EC, the IVDD, under which every IVD outside the two Annex II lists and the self-tests reached the market on the manufacturer's own declaration.

The IVDR binds four economic operators: manufacturers, authorised representatives, importers and distributors. It also governs the person responsible for regulatory compliance, the notified bodies that assess devices, the EU reference laboratories that verify class D devices where one is designated, and the health institutions that make and use their own tests under a conditional exemption.

This overview sets out the identity of the IVDR, its two corrigenda and four amending acts, its scope including genetic tests and online sales, the four risk levels, the shift from self-declaration to notified-body assessment, a map of the obligations by article, and the status of the Commission proposal of December 2025 as of 6 November 2026.

What Is the IVDR?

IVDR stands for In Vitro Diagnostic Medical Devices Regulation, the short name of Regulation (EU) 2017/746 of 5 April 2017, which lays down the EU rules for placing in vitro diagnostic medical devices on the market, making them available and putting them into service, and for performance studies of such devices conducted in the Union. The regulation covers the whole life of an IVD, from its performance evaluation before certification to post-market surveillance and vigilance after it reaches laboratories, clinics and lay users.

The IVDR repealed Directive 98/79/EC, the In Vitro Diagnostic Medical Devices Directive (IVDD), and Commission Decision 2010/227/EU on the database under the directives; the decision falls away from the later of 26 May 2022 and the EUDAMED date set in IVDR Article 113(3)(f). The IVDR was adopted on the same day as Regulation (EU) 2017/745 on medical devices, and both acts together form the framework of the EU MDR and IVDR.

What are IVDR regulations, then? The IVDR is one regulation, completed by its amending acts and by implementing acts such as the common specifications for certain class D devices. Guidance from the Medical Device Coordination Group (MDCG), the one group that serves both regulations under IVDR Articles 98 and 99, explains how to apply the IVDR and is not legally binding.

Identity: CELEX Number, Official Journal and Key Dates

Regulation (EU) 2017/746 has CELEX number 32017R0746 and was published in OJ L 117, 5.5.2017, p. 176, in the same issue as the MDR (p. 1). Its legal basis is Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, and it went through procedure 2012/0267/COD, starting from Commission proposal COM(2012) 541. The text has 101 recitals, Articles 1 to 113 plus Article 10a in 10 chapters, 15 annexes and 74 definitions in Article 2. The 15 annexes run from the general safety and performance requirements (Annex I) through the classification rules (Annex VIII) and the three conformity assessment annexes (IX to XI) to the correlation table with Directive 98/79/EC (Annex XV). The text as published is on EUR-Lex under CELEX 32017R0746.

The IVDR entered into force on 25 May 2017 (IVDR Article 113(1)); 5 May 2017 is the publication date, not the date of entry into force. The date of application, 26 May 2022 (IVDR Article 113(2)), was never postponed. Parts of the IVDR applied earlier, on three dates set by IVDR Article 113(3): the notified-body provisions of Articles 31 to 46 and Article 96 on competent authorities from 26 November 2017, Article 97 on cooperation from 26 May 2018, and Article 100 on EU reference laboratories from 25 November 2020. EUR-Lex also offers consolidated versions that build the corrigenda and amendments into one text, but consolidated texts have no legal effect, so the Official Journal texts of the regulation and its amending acts remain the reference.

The identity data of the IVDR are summarised in the table below.

A Regulation, Not a Directive

The IVDR is binding in its entirety and directly applicable in all member states, so no national law transposes it and "IVDR Richtlinie" (Richtlinie means directive) is a misnomer. The IVDD worked the other way: member states had to transpose it by 7 December 1999 (IVDD Article 22(1)). The IVDR shares its legal form with the EU MDR (Regulation (EU) 2017/745), which has applied since 26 May 2021.

National laws implement only what the IVDR leaves to member states. Three examples are the rules on penalties, which IVDR Article 106 required member states to notify by 25 February 2022, the official Union language or languages of the information supplied with a device (IVDR Article 10(10)), and the designation of competent authorities under IVDR Article 96. A member state may also keep a national registration of distributors, which IVDR Article 27(2) permits.

Corrigenda and the Four Amending Acts

Two corrigenda correct the OJ text (OJ L 117, 3.5.2019, p. 11 and OJ L 334, 27.12.2019, p. 167), and four acts amend it: Regulation (EU) 2022/112, Delegated Regulation (EU) 2023/503, Regulation (EU) 2023/607 and Regulation (EU) 2024/1860. The four amending acts and what each changed for the IVDR are listed in the table below.

Corrigenda: OJ L 117, 3.5.2019, p. 11 and OJ L 334, 27.12.2019, p. 167.

Regulation (EU) 2023/607 of 15 March 2023, proposed as COM(2023) 10, also replaced the second paragraph of IVDR Article 112, and Regulation (EU) 2024/1860 of 13 June 2024 came from proposal COM(2024) 43. Implementing acts, such as Commission Decision (EU) 2025/2371 on EUDAMED or Implementing Regulation (EU) 2022/1107 on common specifications, are not amendments of the IVDR.

Of the MDR and IVDR amendments since 2017, Regulation (EU) 2020/561 amended only the MDR, so it is not an IVDR amending act. Regulation (EU) 2024/1860 inserted IVDR Article 10a, which has applied since 10 January 2025: a manufacturer informs the competent authority and the economic operators, health institutions and healthcare professionals it supplies directly at least 6 months before an anticipated interruption or discontinuation of supply of certain devices, other than in exceptional circumstances. The full change history is kept under MDR and IVDR amendments.

Who and What the IVDR Covers

The IVDR covers in vitro diagnostic medical devices and their accessories placed on the market, made available or put into service in the Union, and performance studies of such devices conducted in the Union (IVDR Article 1(1)). The territorial test is the Union market: a manufacturer outside the Union that places an IVD on that market falls under the same rules.

The duties fall on the economic operators: manufacturers (IVDR Article 10), authorised representatives (Articles 11 and 12), importers (Article 13) and distributors (Article 14). Article 15 adds the person responsible for regulatory compliance, and Article 16 sets the cases in which manufacturer obligations apply to importers, distributors or other persons.

Health institutions are a further group the IVDR reaches. In-house devices, manufactured and used only within a health institution as defined in IVDR Article 2(29), can be exempt under IVDR Article 5(5) when they meet its nine conditions, points (a) to (i), which apply in stages; the conditions are set out under in-house devices under Article 5(5) IVDR.

Products in Scope and the Four Exclusions of Article 1(3)

Under IVDR Article 2(2), an IVD is a medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, intended to be used in vitro to examine specimens derived from the human body, including blood and tissue donations. The definition names six purposes, points (a) to (f): information on a physiological or pathological process or state, information on congenital physical or mental impairments, information on a predisposition to a medical condition or disease, information on safety and compatibility with potential recipients, the prediction of treatment response or reactions, and the definition or monitoring of therapeutic measures. Specimen receptacles count as IVDs (IVDR Article 2(3)), and IVDR Article 2(4) defines an accessory for an IVD.

IVDR Article 1(3) excludes four product groups from the regulation, listed below.

• General laboratory products and research-use-only products, point (a), unless their manufacturer specifically intends them for in vitro diagnostic examination.
• Invasive sampling products and products applied directly to the human body to obtain a specimen, point (b).
• Internationally certified reference materials, point (c).
• Materials used for external quality assessment schemes, point (d).

Three elements of the definition are new against the IVDD: software, predisposition under point (c) and the prediction of treatment response under point (e). These additions bring software and predictive tests into the in vitro diagnostic medical device concept; the full definition with its examples is explained under in vitro diagnostic medical device (IVD).

Genetic Tests: Information, Counselling and Consent under Article 4

IVDR Article 4 places a duty on member states, not on manufacturers: they ensure that a person tested with a genetic test receives information on the test. Article 4 groups three elements for genetic tests, information, counselling and informed consent, and it applies alongside the IVD definition, whose point (c) covers tests that give information on a predisposition to a medical condition or disease.

Counselling is the element with a defined trigger. Member states ensure counselling where a genetic test gives information on a genetic predisposition to conditions or diseases that are untreatable. IVDR Article 4(3) lifts the counselling duty in two cases: where the test confirms a diagnosis the person is already known to have, and where a companion diagnostic is used. Informed consent for performance studies is a separate matter under the IVDR, governed by IVDR Article 59.

Distance Sales and Online Testing Services under Article 6

IVDR Article 6 brings distance sales into the regulation's scope, including diagnostic services offered online. The definition of a device for self-testing in IVDR Article 2(5) points the same way: it covers any device intended to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services. The MDCG's list of ongoing guidance work, in its January 2025 version that the Commission still linked on 6 November 2026, includes a Q&A on IVDR distance sales; that item is planned work, not published guidance.

The IVDR in Five Detailed Pages

Five pages cover what this overview summarises: the legacy-device periods, the seven classification rules, the conformity assessment routes, companion diagnostics and self-tests with near-patient tests. Each page gives the article and annex references that this overview only names, and the table below lists the question each page answers and its legal hook.

Legacy IVDs may be placed on the market or put into service until 31 December 2027 if they carry an IVDD certificate or were self-declared and are now class D, until 31 December 2028 if self-declared and now class C, and until 31 December 2029 if self-declared and now class B or sterile class A (IVDR Article 110 as amended by Regulation (EU) 2024/1860). Every legacy IVD needed an IVDR quality management system by 26 May 2025, and the two condition dates still open as of 6 November 2026, the formal application by 26 May 2027 and the written agreement by 26 September 2027, apply to self-declared class B and sterile class A devices; non-sterile class A devices had no transition.

Four Risk Levels and Seven Rules

The IVDR sorts every IVD into one of four classes, A, B, C and D from lowest to highest risk (IVDR Article 47(1)), by applying the seven rules of Annex VIII Section 2 together with its implementing rules 1.1 to 1.10. The MDR uses a separate system of 22 rules and classes I, IIa, IIb and III for medical devices. Software that is an IVD is classified under the IVDR rules through implementing rule 1.4, never under MDR Rule 11, as MDCG 2019-11 rev.1 explains.

Where the IVDD tied notified-body involvement to the lists of its Annex II and to self-testing, the IVDR ties it to the class. MDCG 2020-16 rev.5 of September 2026, announced by the Commission on 9 September 2026 with changes to the guidance on Rule 7, explains how to apply the seven rules, and notified bodies take such guidance into consideration under IVDR Annex VII Section 1.6.2. Companion diagnostics, for example, are class C under Annex VIII Rule 3(f).

The class decides four things, compared in the table below: how far a notified body is involved, which post-market document the manufacturer writes, whether a summary of safety and performance (SSP) is required, and from when the UDI carrier must appear on the label. For certain class D devices, the common specifications of Implementing Regulation (EU) 2022/1107 (OJ L 178, 5.7.2022, p. 3) have also applied since 25 July 2024. Read across the rows, the duties grow with the class: class D devices carry the most, and non-sterile class A devices the fewest.

From Self-Declaration to Third-Party Assessment

Under Directive 98/79/EC notified bodies certified the devices in Annex II List A and List B and examined the design of self-tests, while every other IVD reached the market on the manufacturer's own declaration; the IVDR requires a notified body for classes B, C and D and for the sterile aspects of class A. The IVDD, Directive 98/79/EC of 27 October 1998 (OJ L 331, 7.12.1998, p. 1), was repealed from 26 May 2022 with the exceptions of IVDR Article 112, and it still applies to the extent needed for legacy devices. Its notified-body decisions lasted at most 5 years (IVDD Article 9(10)), and the whole directive had 24 articles and Annexes I to X.

Under the IVDR, the manufacturer of a non-sterile class A device draws up the technical documentation and the EU declaration of conformity alone (IVDR Articles 17 and 48(10)), and its CE marking carries no notified-body number. For every other class, the identification number of the notified body follows the CE marking (IVDR Article 18(5)). Certificates last at most 5 years and are renewable (IVDR Article 51(2)). The notified bodies themselves are designated under Chapter IV, Articles 31 to 46, and undergo a complete re-assessment every 5 years under IVDR Article 40(10) as amended by Delegated Regulation (EU) 2023/503. Class D adds two checks: verification by an EU reference laboratory where one is designated (IVDR Article 48(5)), and consultation of an expert panel where no common specifications exist and the device is certified for the first time (IVDR Article 48(6)). EU reference laboratories are designated by implementing act: Implementing Regulation (EU) 2023/2713 covers four scopes, with tasks from 1 October 2024, and Implementing Regulation (EU) 2025/2526 adds two, with tasks from 1 May 2026.

Shares of IVDs that need a notified body under each regime circulate in secondary sources, but none rests on a primary source, so this page gives no percentage. The IVDD also exempted in-house devices without any conditions (IVDD Article 1(5)), where the IVDR sets the conditions of its Article 5(5). The full IVDD vs IVDR comparison sets the two regimes side by side.

What the IVDR Asks of Manufacturers and Other Operators

The IVDR sets its obligations article by article, and the table below maps each group of articles to the page that explains it. Before a device is placed on the market, the manufacturer meets the general safety and performance requirements of Annex I, demonstrates performance in a performance evaluation under Article 56 and Annex XIII, records the evidence in the technical documentation of Annexes II and III, and signs the EU declaration of conformity of Article 17. Traceability follows through the UDI system of Articles 24 and 25 and registration in EUDAMED under Articles 26 to 30. After placing on the market, the manufacturer runs post-market surveillance under Articles 78 to 81 and reports serious incidents and field safety corrective actions under Articles 82 to 87, while competent authorities carry out market surveillance under Articles 88 to 95.

Documentation is kept for at least 10 years after the last device is placed on the market (IVDR Article 10(7)), double the 5 years of IVDD Article 9(7). Harmonised standards whose references are listed under Implementing Decision (EU) 2021/1195 give a presumption of conformity (IVDR Article 8). The EU declaration of conformity carries the same 10 Annex IV items under the MDR and the IVDR, including the Basic UDI-DI. The 17 groups of provisions and their pages are listed below.

The Commission Proposal of December 2025

The Commission proposed a targeted revision of the MDR and the IVDR on 16 December 2025 (COM(2025) 1023, procedure 2025/0404(COD)); as of 6 November 2026 it is pending at the stage "Awaiting committee decision" in the European Parliament's SANT committee and is not law. The IVDR therefore applies as described on this page until a revision is adopted and published. Besides the two regulations, the proposal would also amend Regulation (EU) 2022/123 on the support of the European Medicines Agency for expert panels.

For IVDs, the proposal would not change the classification rules and would not move the 2027, 2028 and 2029 legacy end dates. The IVD changes it would make include those listed below.

• A grandfathering route for orphan legacy devices.
• Removal of the in-house condition that no equivalent device is available on the market.
• Periodic reviews in place of the 5-year cap on certificate validity.
• A principal-or-ancillary test for devices that combine an IVD with a medical device.
• An Annex IX Section 5.1 assessment limited to self-tests.
• Electronic instructions for use for near-patient tests.

The past procedural events on the file, as of 6 November 2026, include the appointment of the rapporteur on 13 February 2026, the opinion of the European Economic and Social Committee of 29 April 2026, the draft report of the SANT committee of 30 June 2026 and the amendments of 28 July 2026. The stage is recorded in the OEIL procedure file 2025/0404(COD), and the proposal text is on EUR-Lex under COM(2025) 1023.

IVDR Status Summary

As of 6 November 2026, the IVDR has applied for more than four years, four amending acts have changed it, and a targeted revision is pending in the European Parliament. One change took effect during 2026: four EUDAMED modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) have been mandatory since 28 May 2026, under Commission Decision (EU) 2025/2371 and IVDR Article 113(3)(f) as amended by Regulation (EU) 2024/1860. The other two modules, vigilance and post-market surveillance, and clinical investigations and performance studies, were not mandatory as of 6 November 2026. The legacy periods and their open condition dates are set out in the detailed-pages section above.

Dates ahead in the IVDR include the three below.

• 26 May 2027: the UDI carrier becomes mandatory on the label of class A devices (IVDR Article 113(3)(e)).
• 27 May 2027: the Commission's evaluation report on the application of the IVDR is due (IVDR Article 111).
• 31 December 2030: in-house point (d) applies (IVDR Article 113(3)(j) as amended by Regulation (EU) 2024/1860).

On 15 April 2026, the Commission announced a pilot programme for breakthrough devices and IVDs on its in vitro diagnostics page.

Where the IVDR Stops

The IVDR ends where a product is not an IVD, where a medical device is the integral part, or where the old Directive still governs a legacy device. Two boundaries recur in practice: the abbreviation and the other regulation.

Product or Law: Telling the Two Abbreviations Apart

An IVD is the product, defined in IVDR Article 2(2); the IVDR is the law that regulates it, and the IVDD was the directive that regulated IVDs before it.

Is CE IVD the same as IVDR? Not always: the CE marking on an IVD can rest on an IVDD declaration or certificate, for a legacy device under IVDR Article 110, or on an IVDR conformity assessment, and both are lawful, the legacy basis only until the Article 110 dates. The steps behind the marking are explained under CE marking for medical devices and IVDs.

Devices That Fall under the Other Regulation

A device that incorporates a medical device as an integral part is governed by the MDR, while the IVD part must meet the IVDR (IVDR Article 1(4)).

The boundary also runs the other way. MDR Article 1(6)(a) excludes IVDs from the MDR, and needles, lancets and swabs used to take a specimen are MDR devices, because IVDR Article 1(3)(b) excludes invasive sampling products.

Both regulations share EUDAMED and the MDCG, and a point-by-point MDR vs IVDR comparison covers the rest.