EU Authorized Representative: What Non-EU Medical Device Manufacturers Need to Know

Medical manufacturers based outside the European Union must appoint an EU Authorized Representative before placing their products on the EU market. Per the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746, a manufacturer who is not established in an EU Member State may place a device on the EU market only after designating a sole Authorized Representative. This applies regardless of company size or device risk class.

What Is an EU Authorized Representative? 

An EU Authorized Representative, commonly called an “EU AR,” is a natural or legal person established within the European Union that has received and accepted a written mandate from a manufacturer located outside the EU. The AR acts on the manufacturer’s behalf for the regulatory tasks specified in the mandate. 

Serves as an important contact point between the non-EU manufacturer and EU competent authorities. This AR role is legally different from an importer or distributor. A manufacturer must appoint only one AR for devices belonging to the same generic device group.

Core Responsibilities of the EU AR 

Under Article 11 of the MDR and IVDR, the AR must perform: 

• Verify EU Declaration of Conformity and technical documentation have been prepared. 
• Check that the correct conformity assessment procedure has been completed, where required. 
• Keep copies of the technical documentation, Declaration of Conformity (DoC), and applicable certificates available to competent authorities. 
• Complete its own registration obligations and verify that the manufacturer has met the applicable UDI and device registration requirements. 
• Forward authority requests of device samples or access to the manufacturer and verify that the requested samples or access are provided.
• Cooperate with authorities during corrective actions, recalls, and other safety actions. 
• End the mandate if the manufacturer fails to meet its regulatory obligations.
• The manufacturer remains responsible for device design, manufacturing, quality management, risk management, technical documentation, and post-market surveillance. These duties cannot be transferred completely to the AR. 
• The AR’s name and registered address must also appear on the device label as EU-REP.

The detailed responsibilities are explained in MDCG 2022-16 on Authorized Representatives.

EUDAMED Requirements in 2026 

Since 28 May 2026, four EUDAMED modules have been mandatory: 

• The AR must register in EUDAMED and obtain an Actor ID or Single Registration Number, known as an SRN.
• The non-EU manufacturer submits its own actor registration request. The selected AR checks the information and mandate details before the competent authority performs the final review.
• The manufacturer normally registers its devices, while the AR checks that the registration has been completed. Devices first placed on the EU market after 28 May 2026 generally need to be registered before market placement. 

PRRC Requirement 

• Both the manufacturer and the AR must have access to a qualified Person Responsible for Regulatory Compliance or PRRC.
• The manufacturer’s PRRC oversees technical documentation, post-market surveillance, and vigilance reporting. The AR’s PRRC checks that the AR is completing the duties listed in its mandate.
• The PRRC should have a relevant degree and at least one year of medical-device regulatory or quality experience, or four years of relevant professional experience.
• The same individual should not act as the PRRC for both the non-EU manufacturer and its AR. 

Important Updates for 2026 

For eligible MDR legacy devices, the transition periods generally end on: 

• 31 December 2027 for Class III and most Class IIb implantable devices 
• 31 December 2028 for other Class IIb, Class IIa and relevant Class I devices 

The IVDR deadlines are different: 

• 31 December 2027 for Class D devices and certain devices covered by an IVDD certificate 
• 31 December 2028 for Class C devices 
• 31 December 2029 for Class B and Class A sterile devices 

These extensions apply only when the manufacturer meets all applicable transition conditions. 

Another update is the change from the “EC REP” symbol to “EU REP.” This is mainly a terminology change and does not affect the AR’s responsibilities. Both symbols may continue to be used during the transition period until 17 June 2031.

Choosing the Right EU AR 

Before appointing an AR, the manufacturer should check that the representative: 

• Is legally established in the EU 
• Has an EUDAMED Actor ID or SRN 
• Has access to a qualified PRRC 
• Understands the relevant device type 
• Can securely maintain documents and manage complaints 
• Has clear fees, liability and termination conditions 

How NexorTest Can Help 

NexorTest Technologies supports non-EU medical device and IVD manufacturers with EU market entry planning, technical documentation review, EUDAMED registration support, PRRC coordination and EU AR arrangements. 

Our team can help manufacturers understand the requirements, prepare the necessary documents, and reduce avoidable delays during EU market entry. 

Learn more about our EU MDR services and EU IVDR services or contact our regulatory team to discuss your requirements.