Transitional provisions for certain in vitro diagnostic medical devices (IVDR 2017/746)

Proposal for transitional provisions for certain in
vitro diagnostic medical devices under Regulation (EU) 2017/746

European Commission issued a proposal (2021/0323 (COD)) for the amendment of the transitional provisions under EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR).  Once approved by the council and parliament this will give more time for many IVD manufacturers to comply with the IVDR.

In this case for the up classified (A sterile, B,C,D) devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body and for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the Directive  98/79/EC,  the following dates will apply.

Class D – 26 May 2025

Class C –  26 May 2026

Class B  – 26 May 2027

Class A sterile – 26 May 2027

This proposal does not cover the new devices which will be put on the market after 26 May 2022 and class A devices. So the new comers and class A devices has to comply with IVDR at the date of application 26 May 2022.

 
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