The European Union’s (EU) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements in vitro diagnostic (IVD) manufacturers that distribute products in the EU.
Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and intensified supervision of Notified Bodies are just some of the major changes to be considered as compared to the EU’s previous Directives, In Vitro Diagnostic Directive (IVDD).
NAMSA, in an effort to assist global IVD manufacturers with their compliance planning, has made available several complimentary resources which can be found below. We hope you find these tools to be beneficial as you prepare for the 26 May 2022 implementation date and beyond.
Get started with NAMSA’s Guide: How to Successfully Transition from IVDD to IVDR – a Roadmap of Priorities and Compliance Strategies
Approved IVDR Notified Bodies
- 3EC International a.s.
- BSI Group The Netherlands B.V. (The Netherlands)
- DEKRA Certification B.V. (The Netherlands)
- DEKRA Certification GmbH (Germany)
- GMED SAS (France)
- TÜV Rheinland LGA Products GmbH (Germany)
- TÜV SÜD Product Service GmbH (Germany)
Access this list by clicking here.