Notified Bodies for Active Implantable Medical Devices

Notified Bodies are responsible for ensuring that all the active implantable medical devices brought to the EU Market are safe and compliant. They help the manufacturers by implementing conformity assessment procedures and granting conformity certificates. There are some expectations that a Notified Body must meet before being designated by the EU Authorities. Their main role is to review the technical documentations and approve the Design Dossiers for all AIMD. They decide whether or not to grant them EC-Design Examination Certificates. Selecting the most suitable Notified Body for an active implantable medical device is vital. Manufacturers can choose a Notified Body from the European Commission´s complete directory of Notified Bodies who are accredited for CE marking of active implantable medical devices. It is available on the NANDO website and the list contains more than 60 Notified Bodies from 22 countries (including Turkey and Australia). Nonetheless, selecting a Notified Body device can be a complex process. As such, it is also advised to have an external expert supports this critical decision. For more information about Notified Body for in-vitro diagnostic medical devices, please see our Notified Body Selection page.

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in Active Implantable Medical Devices Directive