EU MDR: Sixteenth notified body is named
Germany's DQS Medizinprodukte has been designated as the 16th notified body under the incoming EU Medical Device Regulation (MDR).
As a result of the Covid-19 pandemic, the EU MDR implementation date was postponed from 26th May 2020 to the same date a year later. This decision was made to allow manufacturers to prioritise supplying safe and well-performing devices to patients, healthcare professionals, and healthcare systems. The In Vitro Diagnostic Regulation (IVDR) was not delayed and is still expected to take effect on 26th May 2022.
There are currently 16 notified bodies approved under the new EU MDR. This includes:
- BSI Assurance UK (United Kingdom)
- BSI Group The Netherlands B.V. (Netherlands)
- CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft (Hungary)
- DARE!! Services B.V. (Netherlands)
- DEKRA Certification B.V. (Netherlands)
- DEKRA Certification GmbH (Germany)
- DNV GL Presafe AS (Norway)
- DQS Medizinprodukte GmbH (Germany)
- GMED (France)
- IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (Italy)
- Intertek Medical Notified Body AB (Sweden)
- MDC MEDICAL DEVICE CERTIFICATION GMBH (Germany)
- MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH (Germany)
- National Standards Authority of Ireland (Ireland)
- TÜV Rheinland LGA Products GmbH (Germany)
- TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
Four companies have also been designated as notified bodies under the EU IVDR, including:
- BSI (Netherlands)
- BSI (UK)
- DEKRA Certification
- TÜV SÜD (Germany)
There are a number of organisations that are awaiting designation for MDR or both MDR and IVDR.