EU IVDR (Regulation 2017/746)

EU IVDR — Regulation (EU) 2017/746 on in vitro diagnostic medical devices — is the European Union regulation governing the placing of IVDs on the EU market. Applicable from May 26, 2022 (with extended transition periods), it is the IVD counterpart of the EU MDR, replacing the earlier IVD Directive (98/79/EC) with a substantially stricter regime.

Scope

IVDR introduces a risk-based classification system (classes A, B, C, D) for IVDs, broader notified-body oversight (with most IVDs requiring notified-body involvement compared to ~10% under the old directive), expanded performance-evaluation requirements, post-market performance follow-up, UDI, Eudamed registration, and stricter rules for companion diagnostics and in-house tests. Compliance is the gateway to CE marking IVDs.

Relationships (see sidebar)

• Normative for the QMS, Design Controls, the DHF / DMR records, and the Risk Matrix.
• Companion to ISO 13485 (QMS), ISO 14971 (risk), and CE marking.
• Pairs with EU MDR (medical devices).

Steward

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