MDCG 2022-8: Application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC

Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular its article 110(3), in terms of scope and timing.

This MDCG 2022-8 document provides guidance as regards the applicability of IVDR requirements to “legacy” and “old” devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable and non-applicable to “legacy devices”.

DOWNLOAD THE MDCG 2022-8 DOCUMENT