Role and Definition of the Authorized Representative under the MDR

An Authorized Representative is an entity based within the European Union, appointed in accordance with Article 11 of Regulation (EU) 2017/745 (MDR). It legally and operationally represents a non-EU manufacturer in all interactions with European market-surveillance authorities. Without appointing an AR, a medical device—regardless of its classification—cannot be lawfully placed on the market in EU Member States.

Mandatory Appointment of an AR – Regulatory and Practical Requirement

Appointing an Authorized Representative is a direct MDR requirement designed to ensure continuous oversight of devices introduced by non-EU manufacturers. The AR becomes the official point of contact for bodies such as Notified Bodies. By regulation, this role cannot be assumed by an importer or distributor, to avoid conflicts of interest. Both the AR and the device must be registered in the EUDAMED database.

Key Responsibilities of the AR under MDR 2017/745

Do kluczowych obowiązków AR według MDR należą:

  • Registering in EUDAMED and obtaining the SRN (Single Registration Number)
  • Verifying device compliance with MDR requirements and checking the completeness of the EU Declaration of Conformity
  • Storing the technical documentation for the required retention period
  • Monitoring post-market safety and clinical performance (PMS)
  • Reporting serious incidents and Field Safety Corrective Actions (FSCA)
  • Co-operating with importers, distributors, and Notified Bodies

Failure to fulfill these duties may result in legal and civil liability for the Authorized Representative.

Single Representation – Only One AR per Device

Under the MDR, a manufacturer may appoint only one Authorized Representative for a given device. Each SRN corresponds to a single product and a single AR. Any change of AR requires updating the entry in EUDAMED and transferring the complete technical documentation.

Steps to Appoint an Authorized Representative – A Four-Step Guide

  1. Select a qualified partner—with demonstrated MDR expertise and experience liaising with Notified Bodies and surveillance authorities.
  2. Conclude a written agreement—defining duties, liabilities, and governance of the partnership.
  3. Register in EUDAMED—obtain the SRN and link the device to the AR.
  4. Transfer the documentation—including the technical file, Declaration of Conformity, and PMS data.

Changing the Authorized Representative – A Five-Step Procedure

  • Formally terminate the previous mandate and specify its end date
  • Update the EUDAMED registration
  • Transfer the technical documentation to the new AR
  • Notify the Notified Body (if applicable)
  • Update device labeling with the new AR’s details

Continuity of representation must be maintained without interruption.

Common Manufacturer Mistakes When Appointing an AR – Risk List

  • Selecting a partner without sufficient regulatory experience
  • Failing to establish a clear written mandate defining each party’s responsibilities
  • Submitting outdated or incorrect documentation in the local language
  • Neglecting to update the EUDAMED registry
  • Overlooking PMS and Vigilance obligations

Pure Clinical’s Support as Your Authorized Representative

Pure Clinical serves as an Authorized Representative under MDR 2017/745 for non-EU manufacturers, providing:

  • Formal representation in EUDAMED, including SRN acquisition and registration confirmation
  • Verification and secure storage of technical documentation, ready for inspections
  • Assistance during certification audits and liaison with Notified Bodies
  • Reporting FSCA and serious incidents in compliance with Article 87 MDR
  • Communication with surveillance authorities and the European Commission on device compliance

Operating to the highest standards of quality and transparency, Pure Clinical ensures full regulatory and operational compliance for every manufacturer it represents in the EU.

FAQ

What is a mandate agreement?

A mandate agreement is a contract regulating cooperation between a non-EU manufacturer and their authorised representative (AR) under Article 11(3) MDR. It must clearly define the scope of the AR’s responsibilities, how these will be performed, and the authorisation to act on behalf of the manufacturer before regulatory authorities. Without this agreement, the AR cannot legally operate in the EU market.

How long must an authorised representative retain technical documentation?

According to Article 10(8) MDR, the technical documentation must be retained for at least 10 years after the last device has been placed on the market, or 15 years for implants. This obligation also applies to the AR, who must ensure immediate access to the documentation upon request from competent authorities.

Is the authorised representative liable for the medical device?

Yes. Under Article 11(5) MDR, the AR may bear joint and several liability with the manufacturer for non-compliant devices. This applies when the manufacturer fails to fulfil their regulatory obligations and the AR has not exercised due diligence in verifying device conformity. In practice, this means the AR can be held legally responsible in EU legal proceedings.