The final text for Medical Devices Regulation has been published in the Official Journal of the European Union on 5th May.
With this publication begins the countdown to implementation:
- The regulation replaces the current directive from 26 May 2020.
- Notified bodies can submit their application for designation under the regulation from 26 November 2017.
- Plans for implementation of Eudamed, the European medical devices database shall be published by 26 May 2018. It should be functional by 26 May 2020.
- Unique Device Identification System will apply from 26 May 2021 for Class III and implantable devices, 26 May 2023 for Class IIa and IIb devices, and 26 May 2025 for Class I devices.
- The coordinated assessment procedure for clinical evaluation shall apply from 26 May 2027.
Regarding the validity of CE certificates issued in accordance to the current directives, the following applies:
- Certificates issued prior to 25 May 2017 remain valid until the end of the period indicated on the certificate.
- Certificates issued after 25 May 2017 remain valid until the end of the period indicated on the certificate, but not later than 27 May 2024.
- It only applies if no significant changes in the design and intended purpose are done.
- After 26 May 2020, the requirements for post market surveillance, vigilance and registration of operators and devices described in the Regulation apply also for those devices.
The text for in vitro diagnostic Medical Devices Regulation has also been published. The main application date is 26 May 2022.
The texts for both regulations can be consulted here.