cen:proj:72189

Guidance on the relationship between CEN ISO TR 20146: 2019 (Medical devices — Post-market surveillance for manufacturers) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Scope

This Technical Report provides guidance on the relationship between CEN ISO TR 20416:2020 (Medical devices – Post-market surveillance for manufacturers) and the requirements in the European Regulations on Medical Devices (MDR)- Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices (IVDR) -Regulation (EU) 2017/746.