EC Medical Devices · January 15, 2024

IVDR Class D/IVDD Final Market Placement

Class D IVDs and IVDD-certified devices can no longer be placed on EU market under the old IVDD regime; full IVDR certification is now required.

High obligation Framework Medical Devices & IVD EU-wide In vitro diagnosticsNotified bodiesCE marking

Class D IVDs and all IVDD-certified devices can no longer be placed on EU market under old IVDD regime. Full IVDR certification required for continued market access.

Dates and deadlines

Compliance Deadline

December 31, 2027

Read the official source ↗

Published by EC Medical Devices. HealthSignal links to the original document; the summary above is extracted from the source text.