European Authorized Representative
The mandatory step to sell your medical device in Europe
The first step to register medical devices in the European Union is to have a reliable European Authorized Representative.
Mandatory under
MDR!
Ready to bring your medical device to Europe?
Medical device manufacturers outside the European Union need a legal representative: the European Authorized Representative (EAR).
It is mandatory for any non-EU company that wants to register and market medical devices in the European Union.
Who needs a European Authorized Representative?
Non-EU manufacturers:
medical device and IVD companies that want to expand into the European Union.
Exporters:
companies already selling internationally that need a trusted European representative.
Ongoing compliance:
companies that need continuous support to maintain European regulatory compliance.
Health-tech startups:
companies planning to internationalize their medical products into the EU market.
Enter the European market with confidence!
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FAQ
Yes. Manufacturers outside the European Union can only market their devices if they appoint a formally designated EAR. Without it, registration is not accepted.
No. The Notified Body is responsible for conformity assessment and certification, while the EAR acts as your official European representative. These are complementary roles.
No. The representative must be established in the European Union and have proven expertise in medical device regulation. The MDR introduced significant responsibilities for EARs, including potential shared legal liability with the manufacturer. Choosing a specialized consultancy reduces risks for both your company and your European clients.
Not recommended. Distributors have commercial interests that may conflict with regulatory responsibilities, and many lack the technical expertise needed to fulfill EAR obligations before EU authorities.
No. Since January 2021, the United Kingdom has required a separate UK Responsible Person (UK RP) for medical devices. Companies seeking access to both markets must appoint distinct representatives.
