What Is an EU Authorized Representative? The 5 Key Questions for Manufacturers Outside the EU

An EU Authorized Representative (EU-REP) is a natural or legal person established in the EU whom a non-EU manufacturer appoints, in writing, to carry out certain regulatory obligations on its behalf. Appointing one under Article 11 MDR or Article 11 IVDR is mandatory: without it, no medical device or IVD may lawfully be placed on the EU market.

Below are the five questions manufacturers ask us most often.

1. Who actually needs an EU-REP?

Any manufacturer established outside the EU that wants to place medical devices or IVDs on the EU market needs one. A manufacturer may appoint different EU-REPs for different generic device groups, but only one EU-REP may be responsible for any single device group at a time. The appointment is made through a written mandate meeting the minimum requirements of Article 11(3) MDR/IVDR, which also sets out the EU-REP's obligations (see below).

2. What are the EU-REP's specific obligations?

Article 11(3) MDR/IVDR sets these out. They include, in particular:

• formally verifying that the EU declaration of conformity and technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out verifying that the EU declaration of conformity and technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out,
• keeping technical documentation, declarations of conformity, and certificates available to the competent authorities for the full retention period of 10 years (15 years for implantable devices),
• verifying that the manufacturer has correctly registered the required information in EUDAMED, and obtaining its own SRN (Single Registration Number),
• cooperating with authorities on preventive and corrective actions, and informing the manufacturer without delay of complaints and authority requests,
• terminating the mandate if the manufacturer acts contrary to its obligations, including notifying the competent authority of the termination.

This is a formal control and communication function. The EU-REP does not substantively review the technical documentation, nor does it assume any of the manufacturer's original obligations under Article 10 MDR/IVDR, such as risk management or the quality management system.

3. Is the EU-REP liable for defective products?

Yes, in two different ways.

The first is Article 11(5) MDR/IVDR. It makes the EU-REP jointly and severally liable with the manufacturer for defective products, but only if the manufacturer failed its Article 10 obligations and has no establishment in a Member State.

The second is general EU product liability law, and it goes further. It can already make the EU-REP jointly and severally liable with the manufacturer and importer, even if the manufacturer did nothing wrong. Today, that law is the Product Liability Directive (85/374/EEC). From 9 December 2026, once Member States have transposed it, a newer version (Directive (EU) 2024/2853) takes over, but the EU-REP's exposure under it stays much the same.

So in practice, an EU-REP's liability risk is broader than Article 11(5) alone suggests. That's worth reflecting in contracts and insurance.

4. What makes a suitable EU-REP?

The EU-REP is a central point of contact for authorities and can end up sharing liability, so it pays to be selective. A few criteria matter most:

• confidential handling of technical documentation, which typically contains sensitive manufacturer information,
• established internal processes for communication with authorities and EUDAMED administration,
• clearly defined response times for authority requests or vigilance cases, set out within the mandate itself.

5. What is the difference between an EU-REP, an importer, a distributor, and a PRRC?

These four roles are frequently confused, but each serves a distinct function:

The EU-REP also needs its own PRRC (Article 15(6) MDR/IVDR), separate from the manufacturer's. Per MDCG 2022-16, the official guidance on authorized representatives, the same person can't hold both roles.

Conclusion

The EU-REP role carries real, clearly defined obligations, plus liability under two separate legal regimes, so it's worth treating the choice as more than paperwork. Solid internal processes, confidential handling of documentation, and clearly defined response times are what actually separate a good EU-REP from a risky one, and they're what actually help to keep your product on the market without complications later on.

Not sure your current EU-REP setup covers everything above? Our team handles EU Authorized Representative services for medical devices and IVDs across the EU, UK, and Switzerland. Get in touch to talk through your situation.