EU Authorised Representative under MDR/IVDR (Article 11)

What this appointment covers

Article 11 sets out a defined, EU-established role: an economic operator that verifies your conformity documentation, keeps it available to authorities, registers with EUDAMED, and acts as your EU contact point. We take on that role. MDR/IVDR consulting is a separate service on getMDR.eu.

Where your technical documentation, risk management file or clinical/performance evidence is not yet ready, we say so before signing a mandate - see Services & pricing for the compliance review options.

What's included

• Compliance review before appointment
• Written mandate meeting MDR/IVDR Article 11 requirements
• EUDAMED registration as your Authorised Representative
• Document availability for national competent authorities
• Cooperation on corrective action and field safety notices
• Annual renewal and ongoing compliance maintenance

How appointment works

1. Send your device type, intended purpose, classification and existing documentation
2. We run a compliance review: applicable route, technical documentation, evidence status
3. If ready, we issue a written mandate and register as your Authorised Representative in EUDAMED
4. If gaps exist, we tell you what is missing before any mandate is signed

Start eligibility check

Article 11 MDR/IVDR: what the Authorised Representative must do

Where a manufacturer is not established in an EU Member State, its devices may only be placed on the Union market if it designates a sole Authorised Representative (Article 11(1)). The designation is the mandate: it is valid only when accepted in writing by the Authorised Representative and covers at least all devices of the same generic device group (Article 11(2)).

Under Article 11(3) the mandate must require, and the manufacturer must enable, the Authorised Representative to at least:

• verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that the conformity assessment procedure has been carried out;
• keep the technical documentation, declaration of conformity and certificates available to competent authorities;
• register in EUDAMED and verify that the manufacturer has completed its own registrations;
• provide authorities with the information and documentation needed to demonstrate conformity, and forward requests for samples or access to a device;
• cooperate with authorities on preventive or corrective action;
• immediately inform the manufacturer about complaints and reports of suspected incidents;
• terminate the mandate if the manufacturer acts contrary to its obligations, and inform the competent authority and Notified Body.

The mandate cannot take over the manufacturer's core obligations under Article 10 (Article 11(4)). Where a non-EU manufacturer has not complied with those obligations, the Authorised Representative is liable for defective devices jointly and severally with the manufacturer (Article 11(5)). The Authorised Representative must also have its own PRRC (Article 15(6)), and its name and address must appear on the label, usually with the EC REP symbol.

Frequently asked questions

When does a medical device manufacturer need an Authorised Representative under MDR?

When the manufacturer is not established in an EU Member State. Under Article 11(1) MDR (and IVDR), its devices may only be placed on the Union market if it designates a sole authorised representative. See who needs an EU Authorised Representative.

What must the Authorised Representative mandate include?

At least the tasks listed in Article 11(3) above. Further tasks can be agreed, but the manufacturer's own obligations under Article 10 cannot be delegated.

Is the Authorised Representative liable for defective devices?

Yes. Where the non-EU manufacturer has not complied with its obligations under Article 10, the Authorised Representative is legally liable on the same basis as, and jointly and severally with, the manufacturer (Article 11(5)). This is why we review your documentation before accepting a mandate.

Does the Authorised Representative need its own PRRC?

Yes. Article 15(6) requires Authorised Representatives to have at least one person responsible for regulatory compliance permanently and continuously at their disposal. See PRRC under Article 15.

Note: This page provides general information. Specific obligations depend on your device classification and applicable EU legislation.