Two regulations, 2017/745 DM and 2017/746 DMDIV, (and no longer directives to be transposed into national law) that are more detailed, more precise, and more legible.
Major changes:
- Much more transparency
- Standardised implementation for all European Union countries
- Improved notified bodies
- A better evaluation before market release
- Increased monitoring following market release
- Inclusion of devices without a medical purpose
- Integration of requirements for the entire distribution chain: manufacturers, representatives, importers, distributors
- A European database: EUDAMED for identifying products released on the market in Europe but also for visualising all incidents relating to medical devices
- Increased requirements for demonstrating clinical safety and performance
Entry into force:
- May 2020 for the regulation 2017/745
- May 2022 for the regulation 2017/746
SEE THE REGULATION FOR MEDICAL DEVICES