Notified Body Sleuthing
Sam Lazzara Resume LinkedIn Profile Documents Services Schedule Call +1 510 397 9739 sam@lazzara.net 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...