The European Commission has published a proposal for progressive transitional arrangements for the new IVD Regulation.
It is proposing to extend the transition period for higher risk diagnostics, such as HIV or hepatitis tests (class D) and certain influenza tests (class C), until May 2025 and May 2026 respectively,
whilst lower risk products in classes B and A would have a transition period until May 2027.
1) The 26 May 2022 date of application is not proposed to be modified:
a) Class A non-sterile – including instruments – come under IVDR from the date of application (DoA)
b) New devices will need to be CE-marked under IVDR after DoA
but
2) The transitional provisions (informally called the ‘Grace Period’) are proposed to be extended to all existing tests that need Notified Body review under the IVDR.
After the DoA:
a) Class D: would have 3 years – until 26 May 2025, (+sell-off period +1 year)
- 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.
and
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.
At this stage this is still only a proposal and it raises further questions. We will be working with BIVDA members and MedTech Europe on this while remaining supportive for our member companies with the preparatory process for certification under the new legislation.
