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In Vitro Diagnostic Regulation (EU) 2017/746

Last reviewed: October 2026 · Sources listed at the end of this page.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices — the "IVDR" — replaces Directive 98/79/EC and covers tests and devices used in vitro for the examination of human specimens (blood, tissue, urine, saliva). It was adopted alongside the Medical Devices Regulation 2017/745 and entered into force on 25 May 2017. Its date of application was 26 May 2022, but the transitional period for legacy devices was extended substantially by Regulation (EU) 2024/1860 and earlier Regulation (EU) 2022/112 in response to severe Notified Body capacity constraints. The IVDR was published in the OJEU as OJ L 117, 5.5.2017, p. 176.

At a glance. The IVDR is the EU law on CE marking of in vitro diagnostic devices and has applied since 26 May 2022. Legacy devices that meet the Article 110 conditions may be placed on the market until 31 December 2027, 2028 or 2029, depending on class. A Notified Body is needed for Classes B, C and D and for the sterility aspects of Class A sterile devices. Next key date: 28 November 2026, for EUDAMED registration of devices already on the market. The Commission’s proposed revision is not yet law.

Legal status and timeline

The IVDR's transitional regime is long because the IVDD let manufacturers self-declare many IVDs that now need a Notified Body under the IVDR, and Notified Body capacity for the IVDR was limited when the Regulation began to apply.

Scope: products covered

Article 2(2) of the IVDR defines an in vitro diagnostic medical device as "any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body". The purpose must be solely or principally:

Examples include laboratory analysers, PCR kits, blood-grouping reagents, glucose self-test devices, pregnancy tests, HIV/SARS-CoV-2 antibody tests, and companion diagnostics. The Regulation extends explicitly to "companion diagnostics" — IVDs essential for the safe and effective use of a specific medicinal product (Article 2(7)) — and to genetic testing.

Risk classification (Annex VIII)

The IVDR classifies IVDs into four classes A through D according to a rule-based system in Annex VIII:

Class B, C and D devices require Notified Body involvement; the routes are set out in Article 48 and listed below. For Class D devices, where an EU Reference Laboratory has been designated the Notified Body must request laboratory verification (Article 48(5) and Article 100), and where no common specifications exist for a first certification of that type of device, relevant experts are consulted on the performance evaluation report (Article 48(6)).

Essential requirements (Annex I)

Annex I sets the general safety and performance requirements, structured similarly to Annex I of the MDR but adapted for IVDs:

Performance evaluation

Article 56 and Annex XIII require a performance evaluation comprising:

The Performance Evaluation Report (PER) is part of the technical documentation and is updated throughout the device's lifecycle. The Periodic Safety Update Report (PSUR) is required for Class C and D devices (Article 81).

Conformity assessment procedures

Article 48 and Annexes IX, X, XI:

Technical documentation

Annexes II and III of the IVDR set the contents — analogous to MDR but adapted for IVDs. Annex II covers the device description, design and manufacturing information, GSPR mapping, benefit-risk analysis, performance evaluation, and information supplied with the device. Annex III covers post-market surveillance including PMS plan, PSUR, and trend reporting. Retention period is 10 years from the last unit placed on the market (Article 10(7)).

EU Declaration of Conformity and CE marking

Article 17 and Annex IV set the Declaration's contents — including the Basic UDI-DI, Notified Body certificate references, and Single Registration Number. Article 18 requires the CE marking; the four-digit Notified Body identification number appears next to the mark for all classes except Class A non-sterile.

UDI and EUDAMED

The UDI system mirrors the MDR (Articles 24–26). EUDAMED's modules for actors, UDI and devices, Notified Bodies and certificates, and market surveillance became mandatory for IVDs on 28 May 2026, on the same timetable as the MDR. Under Article 113(3):

The vigilance and performance studies modules are not yet mandatory, because no notice has been published for them.

In-house IVDs (Article 5(5))

Article 5(5) provides an exemption for IVDs manufactured and used only within health institutions, subject to strict conditions: the institution must have a quality management system, justify that target patient needs cannot be met at the appropriate level of performance by an equivalent CE-marked device on the market, draw up documentation on manufacturing and performance, and report serious incidents. Points (b), (c) and (e) to (i) of Article 5(5) have applied since 26 May 2024; point (d) — the justification that no equivalent CE-marked device is available — applies from 31 December 2030.

Recent and upcoming changes

Related legislation

Common errors

Frequently asked questions

When did the IVDR start to apply?

It entered into force on 25 May 2017 and has applied since 26 May 2022. Legacy devices have transitional periods running to 31 December 2027, 2028 or 2029 under Article 110.

What is the IVDR deadline for each risk class?

Devices self-declared under the IVDD that now need a Notified Body may be placed on the market until 31 December 2027 (Class D), 31 December 2028 (Class C) or 31 December 2029 (Class B and Class A sterile). Devices with an IVDD Notified Body certificate have until 31 December 2027. All of these depend on the Article 110(3c) conditions.

Do Class A devices need a Notified Body?

Non-sterile Class A devices do not: the manufacturer issues the EU declaration of conformity. For Class A sterile devices a Notified Body assesses only the aspects of establishing, securing and maintaining sterile conditions (Article 48(10)).

When does the in-house justification requirement apply?

Article 5(5)(d), the justification that no equivalent device on the market meets the patient group needs, applies from 31 December 2030. Regulation (EU) 2024/1860 replaced the earlier date of 26 May 2028. The other Article 5(5) conditions have applied since 26 May 2024 or, for point (a), since 26 May 2022.

Has the IVDR revision been adopted?

No. COM(2025) 1023 was proposed on 16 December 2025 and is still in the ordinary legislative procedure, so the current IVDR continues to apply.

Sources

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