Formalization of the transition period to the MDR
Medical Device Regulation (UE) 2017/745 (MDR)
It is no longer a surprise, amendment COM/2023/10 to regulation 2017/745 was adopted during the session by the European Parliament.
In concrete terms, following warnings of the risk of shortages in Europe by the parties in the sector, the measures included in this amendment target giving breathing space to manufacturers of medical devices (MD) and implantable medical devices (IMD).
The amendment provides in particular the extension of the transition period by allowing manufacturers to maintains their products on the market which still comply with the directives.
The modification of the transition period is different depending on the product categories (from the MDR):
- May 26, 2026 for class III custom-made implants.
- December 31, 2027 in the case of class III and IIb implantable devices
- December 31, 2028 for non-implantable Class IIb, Class IIa and Class I products requiring a NB
On the other hand, manufacturers must set up their quality management system (QMS) according to the MDR’s requirements before 05/26/2024 and have submitted a certification application to a NB before 09/26/2024.
Be careful, to avoid a new sensitive situation in the future we recommend manufacturers to anticipate their transition to RDM as soon as possible.
For the technical part of your files, the LCIE bureau Veritas, as a reference test laboratory in the sector, offers you its conformity assessment, testing and documentary analysis services, according to the latest editions of the applicable medical standards.
You will find below the standards to be harmonized according to the RDM :
- List of standards to be harmonized by the commission: https://urlz.fr/kSVo
- Early 2023 amendment to this list: https://urlz.fr/kSUX
Want to find out more ? Contact us !
Damien AIRAULT, Sales Engineer
damien.airault@bureauveritas.com