European Authorized Representative (EC REP)

Your Partner for EU Market Entry

For medical device manufacturers located outside the European Union, appointing a European Authorized Representative is a legal requirement. Angell Technology GmbH acts as your competent EC REP,ensuring that your products meet all requirements of the MDR (EU) 2017/745. We help you navigate the complex regulatory landscape safely and successfully expand your market presence in Europe.

Our Services as Your EU Authorized Representative

We take full responsibility for your regulatory compliance and serve as the official interface to the European market supervisory authorities.

EUDAMED Management & Registration

We carry out the necessary registrations in the European database for medical devices(EUDAMED).

• Actor registration (SRN application).

• Support for UDI assignment and product registration.

• Continuous data maintenance in accordance with legal deadlines.

Document Review & Compliance Check

Before your products reach the European market, we subject your technical documentation to a rigorous review.

• Verification of the Declaration of Conformity and technical files.

• Review of labeling and instructions for use (IFU).

• Management and provision of documentation for national authorities.

Legally Secure Contracts & Monitoring

As your EAR, we ensure that all contractual foundations meet current requirements. We support you with Post-Market Surveillance (PMS) and the reporting of serious incidents (Vigilance), ensuring your EU business stands on a secure long-term foundation.

Do you want to distribute your medical devices in the EU? Contact us for a non-binding consultation regarding our EAR services.