European Authorized Roles
Understanding the European Authorized Representative: Roles, Responsibilities, and Procedures
In the realm of medical devices and in vitro diagnostic devices, the European Authorized Representative (EC Rep) plays a pivotal role in facilitating access to the European Union market for non-European manufacturers. Mandated by the EU MDR 2017/745 and IVDR 2017/746, the EC Rep acts as the bridge between manufacturers located outside the EU and the European market. This blog post delves into the significance of the European Authorized Representative, their roles, responsibilities, and the procedure for appointing or changing one.
I. The European Authorized Representative (EC Rep)
The European Authorized Representative, or EC Rep, is an entity legally established within the European Union and entrusted with a written mandate from a non-European manufacturer. This mandate allows them to represent the manufacturer's interests and responsibilities concerning regulatory compliance and market access within the EU.
II. Roles and Responsibilities of the European Authorized Representative
(A) Import and Market Access: Non-EU manufacturers seeking to import and sell medical devices and in vitro diagnostic devices within the European Union must designate a single European Authorized Representative.
(B) Written Mandate: The mandate granted to the EC Rep serves as their authority, applying to all devices within the same generic device group, provided it is approved in writing through a mutually signed EAR agreement.
(C) Tasks and Obligations: The EC Representative must carry out specific duties stipulated in the written mandate between the manufacturer and the EC Rep. This includes keeping copies of technical documentation, EU declarations of conformity, and relevant certificates available to competent authorities. The EC Rep is also responsible for collaboration with competent authorities in any necessary preventive or corrective actions regarding devices.
(D) Non-Delegable Duties: Certain obligations outlined in the mandate cannot be delegated to any other entity.
(E) Legal Liability: If a non-EU manufacturer fails to meet obligations under Article 10, the European Authorized Representative becomes legally liable for defective devices on the same basis as the manufacturer.
(F) Termination of Mandate: In case the EC Rep terminates its mandate, the competent authority and relevant notified bodies must be promptly notified, along with the reasons for termination.
III. EAR Agreement: A Formal Collaboration
The appointment of a European Authorized Representative involves the signing of a contractual agreement between the manufacturer and the EC Rep. This agreement outlines the rights, responsibilities, collaboration, and costs of both parties.
IV. Changing an Existing European Authorized Representative
If a manufacturer wishes to change their EC Rep, the detailed arrangements for the change should be defined in an agreement involving the outgoing EC Rep, the manufacturer, and the incoming EC Rep. The agreement should address crucial aspects such as providing a registered EU address on the product packaging, updating technical documentation, and representing the manufacturer before relevant authorities.
The European Authorized Representative serves as an indispensable link between non-European manufacturers and the EU market, ensuring compliance with regulatory requirements and facilitating access to the European market. By understanding the roles, responsibilities, and procedures associated with the EC Rep, manufacturers can streamline their entry into the European Union market and thrive in the dynamic landscape of medical devices and in vitro diagnostic devices.