🇪🇺European Union Medical Device Regulations

European Database on Medical Devices

EU central database for medical device registration, UDI, certificates, and vigilance. First four modules mandatory from May 28, 2026. Decision 2025/2371 declared EUDAMED functionality.

FAQ on MDR/IVDR and Artificial Intelligence Act

FAQ on interplay between MDR/IVDR and the EU Artificial Intelligence Act. Addresses AI-enabled medical devices and dual compliance requirements.

Medical Device Regulation - Consolidated Version 2025

Consolidated version of EU MDR including all amendments through January 2025. Includes extended transition periods, Article 120 amendments, and supply chain notification requirements (§10a).

In Vitro Diagnostic Regulation - Consolidated Version 2025

Consolidated version of EU IVDR including all amendments through January 2025. Class D devices transition by May 26, 2025; Class C by May 26, 2026.

Guidance on Breakthrough Devices (BtX)

Guidance on Breakthrough Devices under MDR 2017/745 and IVDR 2017/746. Addresses expedited assessment pathways for innovative devices.

Amendment to MDR and IVDR Transition Provisions

Amends MDR and IVDR regarding transitional provisions. Extends Class III and IIb implantable deadlines to 2028, other devices to 2027. Removes sell-off date.

In Vitro Diagnostic Medical Devices Regulation

EU regulation for in vitro diagnostic medical devices replacing Directive 98/79/EC. Establishes risk-based classification (Class A, B, C, D), performance evaluation, and post-market surveillance requirements.

Amendment to IVDR Transition Periods

Amends IVDR regarding transitional provisions for certain IVDs and deferred application of conditions for in-house devices.

Guidance on Classification of Medical Devices

Guidance on classification of medical devices under Annex VIII of MDR. Provides rule-by-rule interpretation and examples.

Medical Device Regulation

Core EU regulation for medical devices replacing Directives 90/385/EEC and 93/42/EEC. Establishes classification (Class I, IIa, IIb, III), conformity assessment, UDI, and EUDAMED requirements.