Global medical device manufacturers are busy at work with compliance planning activities pertaining to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to meet conformity by May 2021 and May 2022, respectively. Part of conformity planning, of course, it to contract with a Notified Body designated to these regulations to meet current and future regulatory obligations.
Update
As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below.
Notified Bodies Designated to MDR 2017/745
- BSI (Netherlands)
- BSI (UK)
- CE Certiso (Hungary)
- DARE!! Services (Netherlands)
- DEKRA Certification (Germany)
- DEKRA Certification (Netherlands)
- DNV GL Presafe (Norway)
- GMED (France)
- IMQ (Italy)
- Intertek IMNB (Sweden)
- MDC Medical Device Certification (Germany)
- MEDCERT (Germany)
- NSAI (Ireland)
- TÜV Rheinland LGA (Germany)
- TÜV SÜD (Germany)
Notified Bodies Designated to IVDR 2017/746
- BSI (Netherlands)
- BSI (UK)
- DEKRA Certification (Germany)
- TÜV SÜD (Germany)
These lists can be accessed here:
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device and IVD manufacturers.
Additionally, NAMSA provides support to market authorization holders, including implementation of MDR/IVDR requirements, conformity strategies and creation of appropriate technical documentation for submission to Notified Bodies.
NAMSA invites you to access our complimentary MDR/IVDR planning resources by clicking here.
Adrian Keene
Adrian is Director of EMEA Consulting Services at NAMSA where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products. Adrian previously Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In all, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.