European Authorized Representative FAQs

European Authorized Representative FAQs

European Authorized Representative 

A European Authorized Representative (E.A.R.) serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. Authorized Representative should serve as a contact point with the EU member states competent authorities. Medical Device Regulation (MDR) and in vitro diagnostic Medical Device Regulation ([Regulation_(EU)_2017/746]) increases obligations of E.A.R in the field of surveillance of medical devices.

European Authorized Representative for Medical Device

Whether a medical device requires a Notified Body (in the case of Class I sterile/measuring/ resusable or IIa, IIb, III) in order to obtain the CE Marking or is permitted to self-declare (Class I non-sterile, non-measuring), non-EU based manufacturers are legally obligated to appoint an Authorized Representative in order for their products to legally circulate within the EU Market.

EU Authorized representative services

A European Authorized Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorized Representative.Your European Authorized Representative (EC Rep) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.

European Authorized Representative requirements

To become an EU Authorized Representative of a company there are 2 main obligations:Being a natural or legal person established in the European Economic Area (EEA), European Union (EU) & European Free Trade Association (EFTA). You should be explicitly designated (Authorized) by a non-European manufacturer with a written mandate And most importantly you should accept to be the Representative of this company.

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