In 2017, Europe adopted two new regulations designed to replace all existing directives on medical devices and in vitro diagnostic medical devices:
- Regulation 2017/745 on medical devices
- Regulation 2017/746 on in vitro diagnostic medical devices
Contrary to directives that had to be transposed to national law, the regulations are immediately applicable after publication and do not have to be transposed to national law.
However, a deadline has been set up for the compulsory application of these regulations.
- May 2021 for medical devices
- May 2022 for in vitro diagnostic medical devices
These deadlines should be confirmed on a case-by-case basis according to the device and the expiry date of CE certificates
The main objective of these new regulations has been to improve safety and transparency.
- Safety, with a better evaluation before market release and, in particular, the need to have solid clinical data in order to demonstrate safety and performance.
- Safety also, with a major reclassification of in vitro diagnostic medical devices
- Transparency, with the setting up of a European database (EUDAMED) completed by operators after their prior national registration
- Transparency again, with the setting up of the UDI (Unique Device Identification) for traceability
The requirements of these new regulations are more precise and more detailed with, for example, details of the content of technical dossiers and PostMarket Surveillance files.
The manufacturer is no longer the sole player identified. Requirements are defined for representatives, importers and distributors
These new regulations also apply to notified bodies that must be requalified on the basis of new requirements.