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 2021-25, 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’…
