EU Notified Body Perspective on MDR and IVDR Conformity Assessment
A Notified Body provides an insider overview of the seven-step conformity assessment process under the EU Medical Device Regulation and In Vitro Diagnostic Regulation. The article highlights typical issues encountered during assessment and discusses recent regulatory developments. Useful orientation for IVD manufacturers navigating the European regulatory landscape.
The original study
Conformity Assessment of Medical Devices: An Overview from a Notified Body.
- Authors
- Stange AF, Julian E
- Journal
- Journal of market access & health policy
- PMID
- 41573697
Original abstract
This perspective provides an in-depth analysis of the role and tasks of Notified Bodies (NBs) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It explores the conformity assessment process and highlights typical issues encountered. It provides background on the legal framework and roles and tasks of Notified Bodies (NBs). It further explores the seven-step conformity assessment process which aims to ensure that medical devices meet European Union (EU) safety and performance standards. Finally, we highlight typical issues encountered during the process and re-cent developments in the area and conclude with an outlook for the implementation of the MDR and IVDR.