What is MDR?
The Medical Devices Regulation (MDR) sets stringent requirements for the safety and performance of medical devices in the EU.
Full title: Regulation (EU) 2017/745 on medical devices
Type: Regulation | Category: Medical Devices
Who does MDR apply to?
Manufacturers, importers and distributors of medical devices - from plasters to MRI scanners.
Key requirements
Clinical evaluation, Unique Device Identification (UDI), EUDAMED registration, conformity assessment with a notified body and post-market surveillance.
How Conphora helps
Conphora automatically monitors MDR and matches your products against the relevant requirements. The platform identifies gaps, generates documentation and keeps you up to date when the rules change.
With Conphora you can:
- Automatic validation - instantly see whether your products comply with MDR
- Documentation - generate the necessary documentation and declarations of conformity
- Monitoring - get notified when MDR is updated or amended
- Overview - see the compliance status of all your products in one place