Europe – MDCG 2021-25 : Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

At its meeting on 27/28 May 2021, the MDCG set up an ad hoc task-force regarding
the application of transitional provisions laid down in Article 120(3) of Regulation (EU)
2017/745 (MDR) and the consequential application of MDR requirements to ‘legacy
devices’ and to devices placed on the market prior to 26 May 2021 in accordance
with Directives 90/385/EEC or 93/42/EEC.
The report of the MDCG ad hoc task-force on transitional provisions was endorsed by
the MDCG by written procedure held from 23 August to 10 September 2021.
The report of the task-force has been forwarded to all MDCG working groups to
orientate the development of specific guidance documents where the application of
the transitional provisions laid down in Article 120(3) of Regulation (EU) 2017/745 is
relevant.
At its meeting on 19 October 2021, the MDCG agreed to publish the task-force report
as MDCG guidance…