Further to action spearheaded by the Biomed Alliance on behalf of its member societies, including ESE, the European Commission has proposed to extend the transition periods by 2 to 2.5 years for most classes of in-vitro diagnostics and tests.
The transition period for in-house diagnostic tests will be extended to May 2030. Also, when manufacturers anticipate an interruption of supply of a CE-marked devices, and where it is foreseeable this could lead to serious patient harm, manufacturers must inform competent authorities, stakeholders and health institutions and health professionals at least 6 months in advance.
The proposal should be formally approved in the next months, and before the European Elections.
Extended transition periods:
- Class D: 31 December 2027 (was 26 May 2025)
- Class C: 31 December 2028 (was 26 May 2026)
- Class B/A sterile: 31 December 2029 (was 26 May 2027)
- In house devices: extended to 26 May 2030
Read statement by the Biomed Alliance.
20/02/2024