Published on:
18. October 2021

EU Commission Proposes Extension of IVDR Transition Period

On 14.10.2021, the EU Commission published a proposal for the extension of transitional periods for the IVDR. According to this proposal, the start of application on 26.05.2022 is to remain, but applies only to new devices and devices of class A (non-sterile). Old products which are covered by valid certification by a notified body or a declaration of conformity according to IVDD before 26.05.2022 shall be subject to longer transitional periods which end in the years 2025 to 2027 depending on the certification under IVDD or their classification. These products can then continue to be placed on the market by complying with the IVDD and with only individual aspects of the IVDR. EU Council and Parliament still have to agree to the proposal. The press release of the EU Commission with further links to the amendment proposal and a Q&A document on this can be found here.