Regulation (EU) 2022/112, of 25 January 2022, amended the transitional provisions of Regulation (EU) 2017/746, extending them in scope and timing. This allows for progressive roll-out of the new framework.
The extended transition periods concern devices that require involvement of a notified body for conformity assessment under Regulation (EU) 2017/746 and that have a certificate and/or a declaration of conformity that was issued in accordance with Directive 98/79/EC before 26 May 2022.
The length of the transition periods depends on the type of device: higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, have a transition period until May 2027.