Revision of the guidance MDCG 2021-25 on the application of the Regulation (EU) 2017/745 (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 guidance MDCG 2021-25 on the application of the MDR requirements to ‘legacy devices’ has been updated in order to reflect the new transitional provisions introduced by Regulation (EU) 2023/607.

For instance, the guidance helps the manufacturer on how to comply with the obligation to have a QMS compliant with Article 10, section 9 of the MDR. The guidance also helps its reader to understand that the transitional provisions apply to systems and procedure packs that are only made of legacy devices.

DOWNLOAD GUIDANCE MDCG 2021-25 Rev. 1