- This includes devices with IVDD certificates for Annex II or self-tests which had a validity until May 2024
b) Class C: would have 4 years – until 26 May 2026, (+sell-off period +1 year)
c) Class B, plus sterile Class A: would have 5 years – until 26 May 2027 )+sell-off period +1 year) to complete their certification under the IVDR.
3) Europe’s laboratories who manufacture tests in-house are proposed to have 2-6 more years to transition to the IVDR rules on ‘lab-developed test’ (exact time varies per rule)
*Manufacturers eligible to use the extended Grace Period would need to fulfil certain conditions in the IVDR.