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European Commission proposes extended transition periods of In Vitro Diagnostics

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.