Diapharm acts as an European Authorised Representative for medical devices and in vitro diagnostics (IVDs) for companies based outside the European Economic Area.
Manufacturers that are not based in the European Union and intend to market medical devices or IVDs in the European Economic Area (EEA) require an authorised representative to act in their name within the EEA. Despite not being immediately responsible for the manufacturer’s medical devices and IVDs, the authorised representative acts as a contact for the responsible authorities and bears third-party liability for the use of these products within Europe. Diapharm can act as an European Authorised Representative ("EAR" or "EC Rep") on behalf of IVD and medical device manufacturers based outside the EEA.
The services Diapharm offers can go well beyond the formal requirements for a European Authorised Representative depending on the situation. Thanks to our ISO 13485 certification, we are able to offer manufacturers additional support when it comes to specific regulatory issues concerning medical devices and IVDs in Europe, maintenance in accordance with EU standards and much more.