December 5, 2022
Europe’s Medical Device Coordination Group (MDCG) has issued guidance on the responsibilities of Authorized Representatives. The guidance clarifies the role and requirements of an Authorized Representative under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
What is the role of an EU authorized representative?
Manufacturers without a presence in an EU member state are required to appoint an Authorized Representative (also known as an EC REP) who serves as a liaison between manufacturers and the national competent authorities (Ministries of Health). As a manufacturer, your Authorized Representative ensures your compliance with the MDR and IVDR.
The Authorized Representative’s responsibilities include:
- Draw up a mutually agreed written mandate that meets Article II(3) of the Regulations.
- Provide the mandate upon request to the competent authority.
- Assist with certain medical device and IVD registrations, as required.
- Be identified on product labeling throughout Europe.
- Verify the existence of EU declaration of conformity and technical documents.
- Verify that an appropriate conformity assessment is carried out by the manufacturer, if necessary.
- Keep a copy of the EU declaration of conformity.
- Comply with the registration requirements of MDR and IVDR by registering in EUDAMED and updating information within one week of a change.
- Perform the tasks specified in the mandate agreed upon by the authorized representative and manufacturer.
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors.
Important notes about the Authorized Representative role
Manufacturers must list the name and address of the Authorized Representative on the product label, outer packaging and/or instructions for use. Keep in mind that a competent authority may inspect an Authorized Representative at any time to determine if they understand their role, have direct access to client documentation such as the technical file/design dossier and have processes in place to ensure it can fulfill its role as an Authorized Representative.