IVDR: guide to in vitro diagnostics

Short answer: Regulation (EU) 2017/746 (IVDR) became applicable on 26 May 2022, replacing Directive 98/79/EC. It classifies in vitro diagnostic devices by risk (classes A to D) and imposes strict requirements on conformity assessment, performance evaluation, and post-market surveillance. Devices already certified under the old directive benefit from extended transition periods until 31 December 2029 at the latest, subject to specific conditions.

Scope and risk classes

The IVDR applies to in vitro diagnostic medical devices for human use and their accessories placed on the EU market or put into service. Devices are classified under Annex VIII into four risk-based classes:

• Class A (low risk): self-certification by the manufacturer, except for sterile devices;
• Class B (moderate risk): involvement of a notified body required;
• Class C (higher risk): enhanced notified body oversight;
• Class D (highest risk, e.g. HIV and hepatitis tests): most stringent requirements, including testing by an EU reference laboratory.

Manufacturer obligations

Manufacturers must operate a quality management system (Article 10(8) IVDR), maintain a performance evaluation file with clinical evidence, and establish a post-market surveillance system. They must also designate a Person Responsible for Regulatory Compliance (PRRC). Every device must carry a Unique Device Identification (UDI) for traceability purposes. Serious incidents and field safety corrective actions must be reported to the competent national authority.

Transition periods (Regulation 2024/1860)

Existing devices holding a valid IVDD certificate or declaration of conformity issued before 26 May 2022 may benefit from extended transition periods, provided the conditions of Article 110(3c) IVDR are met. The end dates are:

Class	Deadline
D	31 December 2027
C	31 December 2028
B and sterile A	31 December 2029

Manufacturers were required to have an IVDR-compliant quality management system in place by 26 May 2025. The deadline for submitting an application to a notified body varies by class: class D and IVDD-certified devices by 26 May 2025, class C by 26 May 2026, class B and sterile class A by 26 May 2027. A written agreement with a notified body must be signed by 26 September of the respective year.

EUDAMED

As of 28 May 2026, the first four modules of the European database on medical devices (EUDAMED) are mandatory: Actor registration, UDI/device registration, the Notified Bodies and Certificates module, and the Market Surveillance module. The Post-Market Surveillance and Vigilance module and the Clinical Investigations and Performance Studies module are still under development.