European law requires companies based outside the EU that want to enter their products in the single market to appoint an European Authorised Representative (EAR or EC REP).
In addition to Diapharm’s certification for the development, production, final inspection and marketing of medical devices, the pharmaceutical service provider has now also been EN ISO 13485:2016 certified as an EC REP.
Demand for this function has risen dramatically, due in no small part to many companies’ Brexit preparations, as Dr Guido Middeler, Partner and Head of Medical Devices at Diapharm, explains. In all remaining potential Brexit scenarios, the United Kingdom will ultimately become a third state for the remaining EU member countries.
The EC REP must be indicated on a product’s packaging. He or she represents the medical device manufacturer in its dealings with the authorities and bears third-party liability for the use of the products. Part of this duty includes appointing a safety officer. Diapharm takes on this responsibility on manufacturers’ behalf.
Diapharm General Manager Ralf Sibbing said: “Our services as an EC REP can also go beyond the regulatory requirements. Diapharm’s years of experience and certified quality management systems enable it to take on a very wide range of responsibilities, from acting as an EC REP to playing the legal role of manufacturer.”
As a result, non-European medical device manufacturers can choose whether they want to outsource full manufacturer responsibility for their products to the pharmaceutical service provider or allow Diapharm to represent them in their dealings with the European authorities.
