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Ad hoc task-force report on legacy device transition endorsed by MDCG

  • Posted by: inetika
  • Category: GLOBAL NEWS

An ad hoc task force of the EC Medical Device Coordination Group (MDCG) recently issued a report to the group clarifying many aspects of which transitional provisions in Article 120 of the Medical Device Regulation (MDR, 2017/745) would apply to so-called ‘legacy devices’.

The report recommended that the MDCG accept the report as written and publish it as an official MDCG guidance. On 19 October 2021, the MDCG endorsed the report and published it as guidance document 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’, on 21 October.

Copies of the new guidance can be accessed from here.