Deirdre Caheny

What is an EU Authorised Representative, When Do You Need One, and What Do they Do?

by Deirdre Caheny
According to the EU MDR (European Union Medical Device Regulations), medical device manufacturers must, in some circumstances, appoint a European Authorised Representative in order to obtain CE certification for their products so they can be sold in Europe. What is a European Authorised Representative, though? According to the definition in EU regulations, an Authorised Person must be a "natural or legal person" in the EU. The main role of an Authorised Representative is to represent the manufacturer in dealings with EU regulators. If you are a European-based medical device manufacturer, you will deal directly with regulators. There is no need...