EU MDR (Regulation 2017/745)

EU MDR — Regulation (EU) 2017/745 on medical devices — is the European Union regulation that, since May 26, 2021, governs the placing of medical devices on the EU market. It replaced the earlier Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC) with a substantially stricter, more centralized regime.

Scope

MDR introduces unique device identification (UDI), reclassification of certain devices to higher risk classes, expanded clinical-evidence requirements, mandatory post-market surveillance and periodic safety update reports (PSURs), Eudamed centralized database registration, stricter notified-body oversight, and importer/distributor obligations. Compliance is the gateway to CE marking medical devices for the EU market.

Relationships (see sidebar)

• Normative for the QMS capability, Design Controls, the DHF / DMR records, and the Risk Matrix.
• Companion to ISO 13485 (QMS), ISO 14971 (risk), and CE marking.
• Pairs with EU IVDR (in-vitro diagnostics).

Steward

European Commission, Directorate-General for Health and Food Safety (DG SANTE); enforced by Member State competent authorities and notified bodies.