Classification
8 items
General safety & performance requirements
5 items
Technical documentation
6 items
Conformity assessment
5 items
Clinical evidence
7 items
UDI system
4 items
Special device types
11 items
Pre-market — Getting to market
Everything required to place a medical device or IVD on the EU market under MDR 2017/745 and IVDR 2017/746: classification, GSPR, technical documentation, conformity assessment, clinical evidence, UDI, and special device types.