Notified Body Sleuthing

Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.

Product Labeling

Device labels and instructions for use carry the CE marking if they are associated with devices commercially distributed to Europe. All device classes except “Class I non-sterile non-measuring function” require NB review of the Technical File and also require the 4-digit NB number to be shown adjacent to the CE marking in product labeling. Once you know the NB number, go here to determine the NB name:

Notified Bodies for Medical Device Directive (MDD)
Notified Bodies for Active Implantable Medical Device Directive (AIMDD)
Notified Bodies for In Vitro Diagnostic Medical Devices Directive (IVDD)

List of Notified Bodies under Europe Medical Devices Regulation (EU) 2017/745

List of Notified Bodies under Europe In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

Company Website Information

Search the company website for CE-related information. Search their “Product” and “Health Care Professionals” pages (or the like) for instructions for use. Also, look for press releases related to ISO 13485 registration and CE marking. These press releases will sometimes mention the NB by name. Some USA companies have their website divided into “domestic – USA” and “international” areas, so don’t forget to review both sides, but with more focus on “international”.

Notified Body Client Databases

Some NBs have a searchable database of their clients.  For example:
BSI
DQS-UL
LNE/G-MED
SGS
TUV SUD
Independent Association of Accredited Registrars (IAAR) Database

I would be very interested to hear of other methods and resources for determining Notified Bodies or other CE-related information.

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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