What is IVDR?
IVDR regulates in vitro diagnostic medical devices - devices used to examine samples taken from the human body.
Full title: Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Type: Regulation | Category: Medical Devices
Who does IVDR apply to?
Manufacturers and importers of diagnostic devices such as blood test analysers, pregnancy tests and COVID tests.
Key requirements
Risk-based classification (A-D), clinical evidence, EUDAMED registration, UDI system and conformity assessment.
How Conphora helps
Conphora automatically monitors IVDR 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 IVDR
- Documentation - generate the necessary documentation and declarations of conformity
- Monitoring - get notified when IVDR is updated or amended
- Overview - see the compliance status of all your products in one place