Diapharm acts as an European Authorised Representative (EAR or EC Rep) for medical devices and in vitro diagnostics for companies based outside the European Economic Area. In the UK and Switzerland we act as UK Responsible Person (UK Rep) and Swiss Authorized representative (CH Rep) respectively for medical devices brought on these markets.

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. Companies not based in the UK or Switzerland who want to market their medical devices in these countries, face the same hurdles. 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. Diapharm can act as the European Authorised Representative ("EAR" or "EC Rep") on behalf of IVD and medical device manufacturers based outside the EEA, as UK Responsible Person (UK Rep) for manufacturers based outside of the United Kingdom and/or as the Swiss Authorized Representative (CH Rep) for manufacturers outside Switzerland planning to bring their products on these markets.

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.