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:
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.