EU MDR transition periods for legacy devices
With the publication of Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices on March 20, 2023, manufacturers of existing medical devices (legacy devices*) will benefit from significantly longer MDR transition periods under certain conditions.
The extension of the transition period depends on the risk class of the product, provided that a certificate was issued for it in accordance with the AIMD / MDD guidelines from May 25, 2017 and was still valid on May 26, 2021 and was not withdrawn.
! If these certificates have expired before March 20, 2023, the manufacturer must submit a written agreement with a notified body on the conformity assessment of the product before expiry!
The conditions under which these extended deadlines can be utilized:
- These are legacy products* that continue to comply with the AIMD or MDD,
- There are NO significant changes to the design and purpose,
- the products do not pose an unacceptable risk to the health or safety of patients, users or other persons or to other aspects of public health protection,
- the manufacturer has established a quality management system in accordance with Article 10(9) by May 26, 2024 at the latest,
- the manufacturer or the authorized representative has submitted a formal application for conformity assessment to a notified body by 26 May 2024 at the latest…and the notified body and the manufacturer have signed a written agreement by 26 September 2024 at the latest.
No change to the transitional provisions:
For
- CE-marked products that still do not require the involvement of the notified body in accordance with the MDR Regulation (risk class I).
or - Products that are “new to the market”, i.e. for which:
- neither a certificate from a notified body,
- a declaration of conformity in accordance with the applicable Directive 93/42/EEC (MDD) or 90/385/EEC (AIMD) is available.
The MDR has applied to these medical devices since May 26, 2021.
