Jul 8, 2020
With the recent addition of Intertek’s Sweden-based Notified Body, Intertek Medical Notified Body, to the European Commission’s NANDO database, the number of Notified Bodies designated to issue CE Mark certifications under the Medical Devices Regulation (MDR) now totals 14.
The list of Notified Bodies now designated to at least some components of the MDR following the Regulation’s May 2021 date of application include:
- BSI Assurance UK (UK)
- BSI Group The Netherlands (The Netherlands)
- E Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító (Hungary)
- DARE!! Services (The Netherlands)
- DEKRA Certification (The Netherlands)
- DEKRA Certification (Germany)
- DNV GL Presafe (Norway)
- IMO Instituto Italiano del Marchio Di Qualita (Italy)
- Intertek Medical Notified Body (Sweden)
- MDC Medical Device Certification (Germany)
- Medcert Zertifizierungs- und Prüfungsgesellschaft für die Medizin (Germany)
- National Standards Authority of Ireland (Ireland)
- TÜV Rheinland LGA Products (Germany)
- TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
Additional European MDR compliance and Notified Body resources from Emergo by UL:
- EU MDR preparation and compliance resource center
- European Authorized Representative in-country representation
- Whitepaper: MDR one-year delay and implications for medical device companies
Author
- Stewart Eisenhart