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
- Select a qualified partner—with demonstrated MDR expertise and experience liaising with Notified Bodies and surveillance authorities.
- Conclude a written agreement—defining duties, liabilities, and governance of the partnership.
- Register in EUDAMED—obtain the SRN and link the device to the AR.
- 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 EU Authorized Representative
Pure Clinical acts as an EU Authorized Representative (AR) under Article 11 of the Medical Device Regulation (MDR) 2017/745, representing non-EU manufacturers before EU competent authorities and taking on the regulatory responsibilities this role requires.
Our support as Authorized Representative can cover the full scope of the AR role, from EUDAMED registration and technical documentation verification through audit support and incident reporting, to ongoing liaison with authorities and Notified Bodies.
Depending on the manufacturer’s needs, our support as Authorized Representative includes:
- Formal representation in EUDAMED – acquisition of the Single Registration Number (SRN) and registration confirmation for the manufacturer in the EUDAMED database.
- Technical documentation verification and storage – verification and secure storage of technical documentation, kept ready for inspection by competent authorities.
- Certification audit assistance – assistance during certification audits and liaison with Notified Bodies throughout the conformity assessment process.
- FSCA and serious incident reporting – reporting of Field Safety Corrective Actions (FSCA) and serious incidents in compliance with Article 87 MDR.
- Communication with authorities and the European Commission – ongoing communication with competent authorities and the European Commission on matters of device compliance.
The objective of this support is to ensure that non-EU manufacturers meet their MDR obligations in full, maintain continuous market access in the EU, and remain audit- and inspection-ready at all times.
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?
How long must an authorised representative retain technical documentation?