4 Working Days
30 Working Days
30 Working Days
The role of the EC Rep is vital in ensuring compliance with the regulations and facilitating the import and sale of such medical devices and IVDs within the European Union. The following paragraphs will outline the responsibilities and requirements of the EC Rep designation.
(A) Non-EU manufacturers can only import and sell medical devices and IVDs in the European Union after designing a single EC Rep.
(B) The EC Rep’s designation serves as the authorized representative’s authority. It is effective for all devices in the same generic device group, as approved in writing by the EU Representative in the mutually signed EAR (European Authorized Representative) agreement.
(C) The European-authorized representative must fulfil the tasks specified in the agreed-upon mandate between the EC Rep and the manufacturer. The EC Rep must provide a copy of the EAR Agreement/mandate to the competent authority upon request.
The mandate must include the following duties for the EC Rep regarding the devices it encompasses:
Collaborate with competent authorities on preventive or corrective actions related to devising risks.
Promptly notify the manufacturer of any complaints or reports regarding suspected incidents involving a designated device.
Cancel the mandate if the manufacturer violates its duties under the Regulation.
(D) The mandate specified in Article 10 shall not be delegated.
(E) If a manufacturer not established in a Member State fails to meet the obligations outlined in Article 10, the authorized representative is legally liable for defective devices on the same basis as the manufacturer.
(F) If the EC Rep terminates its mandate, it must immediately notify the competent authority and, if applicable, the notified body involved in the device’s conformity assessment, providing the reasons for termination.
(H) Any reference to the Member State’s competent authority in which the manufacturer has POB shall be interpreted as a reference to the Member State’s competent authority where the authorized representative is established.
The European-authorized representative is represented on the medical device label with a logo. The EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and Instructions for Use (IFU). To appoint an EU Representative, the manufacturer must sign a contract outlining the parties’ rights, responsibilities, collaboration, and costs.
Formalities for Changing an Existing European Authorized Representative
The detailed arrangements for changing the European Authorized Representative should be clearly defined in an agreement between the manufacturer, the outgoing EU Authorized Representative, and the incoming EC Rep. The agreement should address various aspects, including providing a registered address in the EU for product packaging, keeping updated technical Documentation available for inspection, representing the manufacturer in front of relevant authorities, device registration and EU Free Sale Certificates, handling incidents reported by healthcare professionals, complying with regulatory news and updates, checking the Registration of importers and manufacturers with the EU, offering consultation and support