Notified Bodies for Medical Devices
Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They help the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities. A key aspect of their role is to inspect the technical documentations of MDD Is/Im, IIa and IIb as well as review and approve Design Dossiers (for Class III devices) towards granting CE Certificates or EC Design Dossier Certificates. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website). However, as selecting a Notified Body device can be a complex process, it is also advised that an external expert supports this critical decision. For more information about Notified Body for medical devices, please see our Notified Body Selection page.