Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
An Authorised Representative (AR) is a natural or legal person established within the European Union who is formally appointed by a non-EU manufacturer to act on its behalf regarding specific regulatory obligations under the MDR or IVDR.
Our Key Services
Communication with EU Competent Authorities and Notified Bodies.
Review of Technical Documentation and EU Declaration of Conformity.
EUDAMED Registration
Fulfilment of applicable EU Authorised Representative responsibilities under MDR/IVDR.
Why is an Authorised Representative Required?
Manufacturers located outside the EU must appoint an EU-based Authorised Representative to place medical devices on the European market. The AR serves as the primary point of contact between the manufacturer and regulatory authorities, facilitating compliance, communication, and market access. Similarly, manufacturers placing products on the UK market require a UK-based representative.
Key Responsibilities of the Authorised Representative
The AR's responsibilities, as defined in Article 11 of the MDR/IVDR, include:
Verifying that the EU Declaration of Conformity and technical documentation have been prepared and that the appropriate conformity assessment procedure has been followed.
Maintaining copies of the technical documentation, Declaration of Conformity, and applicable certificates for regulatory review.
Ensuring documentation remains readily accessible and up to date throughout the required retention period (at least 10 years after the last device is placed on the market, or 15 years for implantable devices).
Providing competent authorities with the information and documentation necessary to demonstrate device conformity upon request.
Acting as the liaison between manufacturers and competent authorities during inspections, market surveillance, vigilance activities, and regulatory inquiries.
Forwarding requests for device samples or access to devices from competent authorities to the manufacturer and ensuring appropriate responses.
Cooperating in preventive and corrective actions, including recalls and field safety corrective actions (FSCAs).
Promptly informing the manufacturer of complaints, adverse events, or reports received from healthcare professionals, patients, or users.
Importance of Effective Collaboration
Continuous access to current regulatory documentation
Maintenance of effective communication channels.
Maintenance of records demonstrating that required verifications and compliance activities have been performed and be prepared to support regulatory inspections and audits.
Appointing a new EU Authorised Representative requires a written mandate signed by both the manufacturer and the representative, in accordance with the applicable requirements of EU MDR 2017/745 or IVDR 2017/746.
Need to appoint or change your EU Authorised Representative? Connect with MEDREG for seamless regulatory support.
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