1. The latest expiration date of IVD devices (List A, List B, self-testing devices) that have obtained the CE certificate of the notified body according to the IVDD Directive 98/79/EC is May 26, 2025.
2. Devices that do not require the intervention of a notified body according to IVDD Directive 98/79/EC, but require a notified body to carry out conformity assessment in the new IVDR regulation 2017/746:
Pay special attention to:
1) Although the implementation date of IVDR is delayed, the post-market supervision of IVD products using IVDD DOC should be implemented according to the corresponding requirements of post-market supervision in the IVDR regulations from May 26, 2022.
2) Class A non-sterile devices that belong to the OTHER category in IVDD and are self-declared in the new IVDR regulations still need to complete the conversion before May 26, 2022.5.24
Post time: May-27-2022