Notified Body Sleuthing
+1 510 397 9739
Companies developing a new device are often interested to determine the European Notified Body (NB) associated with similar "competitive" devices. Unfortunately, to my knowledge there is no central European database that can be searched for this information. 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)
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".
BSI
DQS-UL
LNE/G-MED
SGS
TUV SUD
I would be very interested to hear of other methods and resources for determining Notified Bodies or other CE-related information.
+1 510 397 9739
Companies developing a new device are often interested to determine the European Notified Body (NB) associated with similar "competitive" devices. Unfortunately, to my knowledge there is no central European database that can be searched for this information. 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)
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.
+1 510 397 9739
