A European Authorized Representative (EAR/EC REP) is a company located in the European Union that acts on behalf of a non-EU medical device or IVD manufacturer for EU MDR and IVDR regulatory compliance. It is generally mandatory for non-EU manufacturers who want to sell products in Europe.
Support for non-EU manufacturers seeking market access, CE Marking, EU MDR/IVDR compliance, EUDAMED registration, and communication with European regulatory authorities.
Practical support for EU Authorized Representative onboarding, MDR/IVDR compliance, documentation review, labelling, and EUDAMED-related activities.
Practical EU MDR and IVDR support for Authorized Representative appointment, documentation handover, labelling updates, EUDAMED coordination, and continued market access.
FAQ
Yes. Non-EU manufacturers generally must appoint an Authorized Representative before placing medical devices or IVDs on the EU market.
An importer may also act as an Authorized Representative only if it is legally established in the EU and formally appointed by the manufacturer to fulfill Authorized Representative obligations.
Responsibilities may include maintaining regulatory documentation availability, coordinating with Competent Authorities, supporting vigilance activities, and verifying compliance obligations.
No. The manufacturer remains responsible for the Technical Documentation and regulatory compliance of the device.
Yes. EAR details are generally required on device labelling and IFU as per MDR/IVDR requirements.
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