Authorized Representative (AR)
An Authorized Representative (AR) is a natural or legal person established in the European Union who accepts a written mandate from a non-EU medical device manufacturer to perform defined regulatory tasks on its behalf under Article 11 of EU MDR 2017/745 or IVDR 2017/746, including documentation verification, registration, and communication with competent authorities.
What is an Authorized Representative (AR)?
The Authorized Representative (AR) is one of the economic operators defined under EU MDR 2017/745, alongside the manufacturer, importer, and distributor. Under Article 11(1), a manufacturer that is not established in an EU Member State must appoint a single Authorized Representative before placing a medical device on the EU market. The same requirement exists under Article 11 of IVDR 2017/746 for in vitro diagnostic medical devices.
The appointment is a legal written mandate, not a commercial agreement alone. The mandate becomes valid only after the AR formally accepts it and must cover at least all devices within one generic device group. The AR does not manufacture the device, own the quality management system, or create the technical documentation. Instead, it verifies regulatory compliance, maintains regulatory documentation, communicates with European authorities, and acts as the manufacturer’s legal representative within the European Union.
Because the AR serves as the regulatory contact point inside Europe, its name and address must appear on the device label in accordance with Annex I of the EU MDR.
Why the Authorized Representative (AR) matters in medical device development
For manufacturers located outside the European Union, appointing an Authorized Representative is not optional—it is a legal requirement for market access. Even a fully compliant device with CE certification cannot legally be placed on the EU market without an appointed AR.
The role also carries significant legal responsibility. Under Article 11(5), if a non-EU manufacturer fails to meet its obligations under Article 10, the Authorized Representative may become jointly and severally liable for defective devices. As a result, experienced AR organizations typically conduct detailed reviews of technical documentation before accepting a mandate.
The AR also plays a central role in EUDAMED registration. Since 28 May 2026, following Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860, the mandatory EUDAMED Actor Registration module requires both the manufacturer and the AR to maintain valid registration information. Delaying the AR appointment frequently delays obtaining the Single Registration Number (SRN) and subsequently delays device registration and market launch.
How the Authorized Representative (AR) mandate works
The responsibilities of an Authorized Representative are defined primarily in Article 11(3) of EU MDR 2017/745.
A typical AR mandate includes responsibility to:
- Verify the EU Declaration of Conformity, technical documentation, and applicable conformity assessment procedure.
- Maintain technical documentation and Notified Body certificates for inspection by Competent Authorities.
- Verify that manufacturer registration and EUDAMED obligations have been fulfilled.
- Respond to requests from Competent Authorities in an accepted official EU language.
- Provide requested documentation, device samples, or access to devices when authorities request them.
- Forward complaints, customer feedback, and suspected serious incidents to the manufacturer.
- Coordinate preventive actions, corrective actions, recalls, and Field Safety Corrective Actions (FSCAs).
- Terminate the mandate if the manufacturer no longer complies with the MDR and notify both the Competent Authority and the Notified Body where required.
However, Article 11(4) makes clear that certain responsibilities cannot be delegated.
The manufacturer always remains responsible for:
- Device design and development
- Compliance with Article 10
- Risk management under ISO 14971
- Quality Management System implementation under ISO 13485
- Clinical evaluation
- Technical documentation
- Post-market surveillance
- Vigilance activities
- Overall regulatory compliance
The Authorized Representative may support these activities but cannot legally assume ownership of them.
In addition, under Article 15, every Authorized Representative must have at least one Person Responsible for Regulatory Compliance (PRRC) permanently and continuously available under a documented contractual arrangement.
Common challenges and best practices
Many manufacturers select an Authorized Representative based primarily on cost. This often becomes expensive later because changing an AR requires:
- Terminating the existing mandate
- Executing a new mandate agreement
- Updating product labeling
- Revising the Declaration of Conformity
- Updating EUDAMED registrations
- Informing relevant Competent Authorities
- Coordinating with the Notified Body where applicable
Documentation management is another common weakness. The AR is expected to maintain access to the current technical documentation—not the version submitted during certification years earlier. Poor document control can quickly become a compliance issue during a Competent Authority inspection.
Manufacturers should also avoid confusing different regulatory roles. The Authorized Representative is distinct from:
- The Person Responsible for Regulatory Compliance (PRRC)
- The Importer
- The Distributor
- The legal representative is required for certain clinical investigations
- A US Agent under FDA regulations
- A UK Responsible Person
- A Swiss Authorized Representative (CH-REP)
Each role serves a different legal purpose.
Successful manufacturers generally:
- Select the AR early in the development program.
- Complete the mandate before Notified Body certification activities begin.
- Provide controlled access to current technical documentation.
- Establish documented complaint and vigilance communication procedures.
- Define rapid reporting timelines for safety events.
- Maintain consistent documentation between the manufacturer and the AR throughout the product lifecycle.
How SJML helps with Authorized Representative (AR)
SJML supports manufacturers preparing for Authorized Representative engagement through its Compliance-as-a-Service model. Its QARA specialists prepare and maintain the documentation an AR expects before accepting a mandate, including technical files, Design History Files (DHFs), Declaration of Conformity documentation, EU MDR technical documentation, labeling, EUDAMED registration support, and post-market surveillance processes.
Because SJML integrates regulatory affairs with engineering, manufacturing, and quality management, documentation remains synchronized with ISO 13485 quality systems and ISO 14971 risk management throughout the product lifecycle, reducing regulatory delays during AR review and Competent Authority inspections.
Frequently asked questions
Any manufacturer located outside the European Union that wishes to place medical devices or IVDs on the EU market must appoint an Authorized Representative before marketing the device.
The requirement applies to manufacturers of all device classes, including Class I, IIa, IIb, III, and IVDR Class A through D devices.
Generally, no.
Article 11 requires a single Authorized Representative for devices within the same generic device group. While manufacturers may theoretically appoint different ARs for separate generic device groups, most organizations use a single AR across their product portfolio to simplify labeling, vigilance, EUDAMED registration, and regulatory communication.
Yes, under certain conditions.
If a manufacturer established outside the EU fails to meet its obligations under Article 10, Article 11(5) makes the Authorized Representative jointly and severally liable for defective devices.
This legal exposure explains why reputable AR organizations carefully review technical documentation before accepting a manufacturer.
The two roles serve different purposes.
The Authorized Representative is an external economic operator legally representing a non-EU manufacturer within the European Union.
The Person Responsible for Regulatory Compliance (PRRC) is a qualified individual responsible for ensuring regulatory compliance within an organization.
Manufacturers require a PRRC, and Authorized Representatives must also have their own PRRC available. These are separate legal obligations under the EU MDR.
Related terms
- EU MDR 2017/745
- Person Responsible for Regulatory Compliance (PRRC)
- EUDAMED
- Declaration of Conformity
- Notified Body
