EU Authorised Representative (EAR) Services: Complete Guide for Non-EU Manufacturers

What Is an EU Authorised Representative?

An EU Authorised Representative (EU AR) is a natural or legal person established in the European Union who is designated by a non-EU manufacturer to act on their behalf in relation to specific regulatory obligations under EU legislation.

The EU AR is not a distributor, importer, or logistics partner — it is a legal and regulatory role with defined responsibilities and legal liability. The AR is named in the EU Declaration of Conformity, on the product label (where required), and in the relevant EU databases (e.g. EUDAMED for medical devices).

The core purpose of the EU AR is to give EU regulatory authorities a legal contact point established in the EU — someone they can reach to discuss compliance, request documentation, or take enforcement action when needed.

Which EU Regulations Require an Authorised Representative?

EU AR, CH-REP, and UKRP — What's the Difference?

Some regulatory service companies can act in all three roles. However, verify they are genuinely established in each jurisdiction — not simply acting through a sub-contractor without a real presence in that territory.

MDR/IVDR EU Authorised Representative: Key Obligations

Under MDR Article 11(3) and IVDR Article 11(3), the EU AR takes on the following obligations alongside the manufacturer:

• Register in EUDAMED as an actor and be linked to each device they represent
• Be named on the device label with the prescribed AR symbol
• Be named in the EU Declaration of Conformity
• Maintain a copy of the DoC and technical documentation, available to authorities on request
• Cooperate with competent authorities regarding vigilance, field safety corrective actions, and market surveillance
• Report suspected serious incidents to the relevant competent authorities where the AR is established
• Immediately inform the manufacturer if the device poses a risk or is non-compliant
• Terminate the mandate and notify authorities if the manufacturer fails to fulfil obligations

GPSR EU Responsible Person Obligations

Under the General Product Safety Regulation (GPSR) 2023/988, the EU Responsible Person (acting as the EU AR equivalent) must:

• Verify that the product is accompanied by required safety information and instructions
• Keep a copy of the Declaration of Conformity or Declaration of Performance
• Cooperate with market surveillance authorities and provide all information necessary to demonstrate product safety
• Inform the manufacturer and authorities of unsafe products
• Have their name and contact details visible on the product or its packaging

This applies to all consumer products — toys, electronics, household goods, clothing, sports equipment — not just CE-marked or regulated categories.

What to Look for in an EU AR Service Provider

Legal establishment

The AR must be a legal entity established in the EU with a registered address — not simply a virtual office or mailbox. In the event of market surveillance or enforcement action, authorities must be able to reach the AR and take legal action if necessary.

Regulatory expertise

An AR for a Class III implantable device needs deep MDR knowledge. An AR for general consumer goods under GPSR needs a different profile. Match the provider's expertise to your product and regulatory framework.

Incident response capability

The AR must be reachable and responsive when authorities contact them — including evenings and weekends in urgent situations. Ask about their incident response process and availability.

Technical documentation access

Under MDR/IVDR, the AR must have access to your technical documentation and be able to provide it to authorities within the required timeframe. Ensure your AR arrangement includes a clear protocol for documentation access.

Contract terms

Review mandate agreements carefully: scope of devices covered, termination notice period, liability allocation, and what happens if the AR company ceases operations or loses regulatory status.

The Mandate Agreement

The formal basis for the EU AR relationship is a written mandate agreement between the manufacturer and the AR. For MDR/IVDR devices, the mandate must be in place before the device is placed on the EU market.

A complete mandate agreement should specify:

• Explicit list of devices covered (by device name, model, and UDI where applicable)
• Scope of the AR's responsibilities
• Documentation access rights and protocol
• Incident and vigilance reporting obligations and procedures
• Termination conditions and notice period (typically 30–90 days)
• Obligations upon termination (e.g. notification to authorities)
• Governing law and jurisdiction
• Confidentiality provisions

Frequently Asked Questions