European Authorised Representative
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.
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.
FAQ
What is a European Authorised Representative (EAR)?
An EAR is a legal entity established in the EU that is mandated by a non‑EU manufacturer to act on its behalf in relation to regulatory obligations for medical devices or IVDs.
When do I need an EAR?
You need an EAR if your company is located outside the EU/EEA but you want to place medical devices or IVDs on the EU market under MDR or IVDR.
Does appointing an EAR change my responsibilities as a manufacturer?
No. The manufacturer remains fully responsible for device conformity; the EAR supports and represents the manufacturer in the EU but does not replace manufacturer obligations.
How do I formally appoint your company as our EAR?
We sign an Authorised Representative Agreement defining scope, devices covered, responsibilities, data sharing, fees, and termination conditions, and then update labeling and regulatory registrations accordingly.
What information and documents do you need from us?
We usually require the latest declarations of conformity, CE certificates, technical documentation access, labeling/artwork, vigilance and PMS procedures, and contact details for your regulatory and quality teams.
Do you provide vigilance and incident support as our EAR?
Yes. We help coordinate communication with EU competent authorities, support field safety corrective actions, and ensure timelines and reporting obligations are met.
How is our technical documentation handled and protected?
We store your documentation securely, restrict internal access to authorized staff only, and can sign additional confidentiality or non‑disclosure agreements if required.
What happens if we change our EAR in the future? (PRRC)?
We support a structured handover, including notifying authorities where necessary, updating labeling and registrations, and ensuring there is no gap in EU representation during the transition.
Are you a non‑EU manufacturer looking to place your CE‑marked products on the EU market?
Reliable Representation for EU Regulatory Affairs