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. Following the approach set out in the report of the
MDCG ad hoc task-force on transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) published as MDCG 2021-252 , the present document provides guidance as regards the applicability of IVDR requirements to ‘legacy
devices’ and ‘old’ devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to ‘legacy devices’.



MDCG 2022-8
Regulation (EU) 2017/746 – 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