Commission proposes to extend IVDR transition and accelerate EUDAMED adoption (From Catapult’s regulatory round-up – January 2024)

The In Vitro Diagnostic Regulation (EU IVDR 2017/746) replaced the In Vitro Diagnostic Medical device Directive (EU IVDD 98/79/EC) and entered into force in 2017 with 26 May 2022 as date of application (DOA). Prior to this, in late 2021 the transition periods for diagnostics to comply with the regulation were extended, due to pressure from industry and fears of a market collapse for diagnostics. At the time, the EU extended the transition periods to 26 May 2025 for high-risk IVDs, 26 May 2026 for moderate-risk IVDs, and 26 May 2027 for lower-risk IVDs. Concerned that in vitro diagnostic manufacturers don’t have enough time to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EC has again proposed extending the regulation’s transition period. Under the new proposal, high-risk class D diagnostics would get until December 2027 to undergo a conformity assessment under IVDR; class C, or high individual and/or moderate public health risk tests, will have until December 2028, and low risk class A sterile and class B tests would have the deadline extended to December 2029.

The EC is also proposing to make some European Database on Medical Devices (EUDAMED) modules mandatory by late 2025. EUDAMED will not become mandatory until all 6 of its modules are in place; however, under its proposed revisions, EUDAMED compliance will be rolled out gradually. Please find further information here.

News Published on the 6th of february 2024. Read the entire regulatory round-up for January following this link.