European Authorised Representative

What is a European Authorised Representative?

A European Authorised Representative (also known as EU AR or EC REP) is the designated legal representative of a non-EU manufacturer within the European Union. This representative must be registered in an EU member state, is responsible for communicating with EU competent authorities, and assumes legal responsibility for product compliance.

According to Article 11 of the EU Medical Device Regulation (MDR 2017/745), non-EU manufacturers must designate an EU AR to legally sell their products. This requirement also applies to In Vitro Diagnostic Medical Devices (IVDR 2017/746) and various ce marking directives.

Which Companies Need to Designate an EU AR?

The following situations require the designation of a European Authorised Representative:

Note: After Brexit, UK companies entering the EU market must designate an EU AR, and simultaneously designate a UK Responsible Person (UKRP) in the UK.

Core Responsibilities of an EU AR

A European Authorised Representative assumes the following legal obligations:

Pre-Market Activities

• Sign the EU AR service agreement to clarify the responsibilities of both parties.

• Review technical documentation and conformity assessment procedures.

• Keep copies of the technical documentation and ce marking certificates.

• Authorize the inclusion of EU AR information on product labels.

EUDAMED Registration Support

• Assist in applying for a Single Registration Number (SRN).

• Ensure the manufacturer fulfills EUDAMED registration obligations.

• Mandatory use of EUDAMED starting May 28, 2026.

Post-Market Compliance

• Retain technical documentation for 10 years (non-implantable) or 15 years (implantable).

• Act as the point of contact for EU competent authorities.

• Provide technical documentation to competent authorities upon request.

• Coordinate Certificate of Free Sale (CFS) applications.

• Forward complaints from healthcare professionals, patients, and users.

• Support incident reporting and Field Safety Corrective Actions (FSCA).

How to Choose a European Authorised Representative?

Choosing an EU AR is a strategic decision that directly impacts market access and compliance risks. Below are the key evaluation criteria:

Five-Point Checklist

1. Technical Depth: Do they understand the regulatory requirements for your products?

2. Response Speed: Can they respond to competent authority inquiries within 24-48 hours?

3. Fee Transparency: Do they charge a fixed annual fee with no hidden costs?

4. Multi-Country Coverage: Can they simultaneously provide EU AR, UKRP, and CH-REP services?

5. Qualification Verification: Do they have the Person Responsible for Regulatory Compliance (PRRC) required by MDR/IVDR?

Common Pitfalls

• Choosing a "virtual" representative with no physical office.

• Ignoring the scope of responsibility clauses in the authorization agreement.

• Failing to confirm whether they have experience operating EUDAMED.

European Authorised Representative Fees

Fees vary depending on product categories and service scope (Note: The original Euro amounts have been converted to USD based on standard exchange rates):

Note: Fees should include EUDAMED registration, SRN maintenance, competent authority communication, and annual vigilance reporting.

JJR Laboratory:

JJR Laboratory provides professional European Authorised Representative services for non-EU manufacturers, helping products enter the EU market compliantly.

Frequently Asked Questions (FAQ)

What is the difference between a European Authorised Representative and an importer?

A: An EU AR is a legal representative responsible for compliance communication; an importer is responsible for the physical entry of products into the EU market. Their responsibilities are different, but the EU AR and the importer can be the same entity.

Can I act as my own EU AR?

A: No. An EU AR must be registered within the EU, so a non-EU manufacturer cannot act as their own representative.

What are the consequences of not designating an EU AR?

A: The products will be banned from entering the EU market, and you may face fines and market surveillance enforcement.

Is an EU AR needed after Brexit?

A: Yes. The UK is now considered a third country, and UK manufacturers must designate an EU AR to enter the EU market.

Does the EU AR assume product liability?

A: In the event that the manufacturer fails to fulfill its obligations, the EU AR bears joint and several liability for defective devices.