EU-REP
European Authorised Representative
EU Authorised Representation and Regulatory Solutions for Medical Devices and IVDs.
Why do you need an EAR?
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), non-EU manufacturers are required to appoint an EU-based Authorised Representative. This representative plays a critical role in ensuring regulatory compliance and serves as the primary point of contact with EU authorities.
At Medunion, we specialize in providing EU Authorised Representative and regulatory consulting services to medical device and IVD manufacturers seeking smooth, compliant access to the European market.
EAR's Responsibilities
As an EU Authorised Representative, Medunion ensures that medical devices placed on the European market comply with the obligations set out in the MDR and IVDR. Our responsibilities include:
Verifying that the EU Declaration of Conformity and the technical documentation have been properly prepared.
Retaining copies of the technical documentation, the EU Declaration of Conformity, and, where applicable, the relevant certificates for availability to competent authorities.
Ensuring compliance with EUDAMED registration requirements and verifying that the manufacturer has fulfilled their corresponding obligations.
Providing competent authorities, upon request, with all necessary information and documentation to demonstrate product conformity.
Relaying requests from competent authorities to the manufacturer regarding product samples or access for inspection.
Cooperating with competent authorities in implementing any preventive or corrective actions.
Promptly notifying the manufacturer of any complaints or reports from healthcare professionals or users concerning the device.
Medunion as your
EU-REP
As your EU Authorised Representative, we ensure your technical documentation and Declaration of Conformity are fully compliant with EU regulations. We retain these documents for inspection by market surveillance authorities and provide guidance on corrective actions when needed. Our services are designed to support your seamless and compliant entry into the European market.
- Simplifying Regulatory Compliance for Medical Devices Across Europe.
