MDCG publishes revised guidance on the application of MDR requirements to legacy devices, MDCG 2021-25 Rev.1
21 October 2024
On 16 October, the Medical Device Coordination Group (MDCG) published the revised guidance on “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”, first released in October 2021. The MDCG 2021-25 Rev. 1 takes into account the amended transitional provisions under “Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices” published in March 2023, according to which the transitional period was extended from May 26, 2024 to December 31, 2027/2028 (depending on the risk class).
The guideline provides orientation for manufacturers of legacy devices who market their products under the MDR. Specifically, the annex of MDCG 2021-25 Rev. 1 offers a non-exhaustive list of the MDR requirements applicable to legacy devices.
The changes, as summarised on page 2 of the revised guidance, mainly concern paragraphs 3.1, 3.2 and 4 and provide clarification on the following points:
- Article 19 MDR does not apply to legacy devices
- Application of the transitional provisions to systems and procedure packs for which a declaration has been drawn up in accordance with Article 12(2) of the MDD
- Requirement to establish a QMS in accordance with Article 10(9) of the MDR
All in all, the revised guideline primarily addresses manufacturers of legacy devices and is intended to support them in meeting the requirements of the MDR.
Feel free to reach out to our experts if you have any questions regarding the revised guidance or need professional advice on how to ensure safety and market compliance of your legacy devices.
