The European Commission has adopted new regulations on the manufacturing of medical devices and in-vitro diagnostic devices across the EU
What will change?
The new regulations aim to modernise the current system by introducing:
- stricter ex-ante control for high-risk devices
- a new risk classification system
- improved transparency through a device traceability system
- an “implant card” containing information about a patient’s implanted medical devices
- reinforced rules on clinical evidence
- strengthened post-market surveillance requirements for manufacturers
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
When will it happen?
The regulations will enter into force following a transitional period of three years for medical devices and five years for in-vitro diagnostic devices.
Take a look at the new factsheet available