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.
EC Medical Devices · January 15, 2024
IVDR Class D/IVDD Final Market Placement: Transition to Full IVDR Certification Required
Original title: IVDR Class D/IVDD Final Market Placement
Class D IVDs and all IVDD-certified devices must now obtain full IVDR certification; placement under the old IVDD regime is no longer permitted.
Compliance Deadline
December 31, 2027
Published by EC Medical Devices. HealthSignal links to the original document; the summary above is extracted from the source text.