EU Representative for Medical Devices (MDR & IVDR)

What Is an EU Representative for Medical Devices?

An EU Representative is the EU Authorized Representative (also written EU Authorised Representative or European Authorized Representative) of a non-EU device manufacturer. It is sometimes called a CE authorized representative, because it is needed to sell CE marked devices in the EU. Whatever the name, it is the same legal role defined in Article 11 of MDR and IVDR.

Every non-EU manufacturer needs one EU Representative for each generic device group. The EU Representative must be established in an EU member state, and its name and address must appear on the device label.

European Authorized Representative Requirements Under MDR and IVDR

Article 11 of the MDR and the matching article of the IVDR set out the tasks of the authorized representative. As your EU Representative, we:

• Verify that the EU declaration of conformity and technical documentation have been drawn up and that the right conformity assessment procedure was carried out
• Keep copies of the technical documentation, declaration of conformity and certificates available to competent authorities (10 years after the last device is placed on the market, 15 years for implantable devices)
• Register as an actor in EUDAMED and check that you have met your UDI and device registration obligations
• Respond to requests from competent authorities and provide information, documents and device samples
• Cooperate with authorities on preventive and corrective actions
• Forward complaints and reports of suspected incidents to you immediately
• End the mandate and inform the authorities and notified body if you act against your obligations under MDR or IVDR

Under MDR and IVDR, the authorized representative is jointly and severally liable with the manufacturer for defective devices if the manufacturer has not met its obligations. The EU Representative must also have a Person Responsible for Regulatory Compliance (PRRC) permanently available. Because of this legal responsibility, an experienced EU Representative protects your access to the EU market.

Who Needs an EU Representative?

The EU Representative Mandate

The appointment must be made through a written mandate, signed by both the manufacturer and the EU Representative. The mandate lists the devices covered and the tasks the EU Representative will carry out. It must cover at least the tasks in Article 11, and the EU Representative must be able to show it to competent authorities on request. We draft and sign the mandate within 2–3 working days.

EU Representative Liability Under MDR Article 11(5)

Under Article 11(5) of the MDR and IVDR, if a non-EU manufacturer has not met its obligations under Article 10, the EU Representative is legally liable for defective devices on the same basis as the manufacturer, jointly and severally with it. This is why a responsible EU Representative checks your declaration of conformity, certificates and technical documentation before signing the mandate, and asks how you meet the Article 10(16) requirement to have sufficient financial coverage for your potential liability.

In practice, joint liability means your EU Representative will want clear, current documentation from you and fast answers on complaints and incidents. A well-organised technical file makes the relationship simple and protects both parties.

Person Responsible for Regulatory Compliance (PRRC)

Article 15(6) of the MDR and IVDR requires every authorized representative to have permanently and continuously at its disposal at least one person responsible for regulatory compliance (PRRC) with the required expertise in EU medical device rules. The PRRC is separate from the manufacturer's own PRRC under Article 15(1). As your EU Representative, we provide a qualified PRRC as part of the service, so you do not need to appoint one in the EU yourself.

Changing Your EU Representative (Article 12)

You can move to a new EU Representative at any time. Article 12 of the MDR and IVDR requires a written agreement between you, the incoming EU Representative and, where practicable, the outgoing one. The agreement must cover:

• The end date of the outgoing mandate and the start date of the new one
• The date until which the outgoing EU Representative may still appear on labels, instructions for use and promotional material
• The transfer of documents, including confidentiality and property rights
• The outgoing EU Representative's duty to forward any complaints and incident reports it receives after the mandate ends

We manage the switch for you: we draft the Article 12 agreement, update your actor data in EUDAMED and give you the new label text, so supply to the EU continues without interruption.

EU Representative vs Importer vs Distributor

The MDR and IVDR give separate roles to each economic operator. The EU Representative (Article 11) acts on behalf of the non-EU manufacturer for regulatory tasks. The importer (Article 13) is the EU company that places your device on the EU market from outside the EU; it must check the CE marking, declaration of conformity, labelling and EUDAMED registration, and add its own name and address to the device or packaging. A distributor (Article 14) makes the device available further down the supply chain.

One EU company can hold more than one role, but each role carries its own legal obligations. Many manufacturers keep the EU Representative independent of their distributor, so a change of distributor does not affect their regulatory status. If you also need an EU importer, tell us in your quote request.

EU Representative for IVD Manufacturers

The IVDR applies the same Article 11 rules to in vitro diagnostic devices. Every non-EU IVD manufacturer needs a European Authorized Representative, including for self-declared Class A devices. Your EU Representative registers in EUDAMED, holds your IVDR documentation for the authorities and handles vigilance communication, just as for medical devices. Our annual fees for IVDR Class A to D match the equivalent MDR classes, and we can also support your IVDR CE marking project.

EU Representative Details on Device Labels

MDR Annex I and IVDR Annex I require the authorized representative's name and registered address on the device label. Most manufacturers use the authorized representative symbol from ISO 15223-1, followed by the EU Representative's name and address. If you change EU Representative, labels must be updated within the transition agreed in the mandate. We give you the exact label text and layout when you appoint us.

EUDAMED Registration and SRN

Use of EUDAMED became mandatory on 28 May 2026 for actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. The EU Representative and the non-EU manufacturer must each register as an actor and receive a Single Registration Number (SRN), validated by the competent authority of the member state where the EU Representative is established. Devices must then be registered in EUDAMED with their UDI data. European Commission – EUDAMED

Competent Authority Registration and Free Sale Certificate

Some member states still require national registration of devices or actors with the competent authority, for example for legacy devices. As your EU Representative we handle these registrations where needed.

Many non-EU countries ask for a Free Sale Certificate (Certificate of Free Sale) showing that your CE marked device is legally sold in the EU. It is issued by the competent authority of the member state where the manufacturer or its authorized representative is established, so a non-EU manufacturer obtains it through its EU Representative. We apply for the Free Sale Certificate on your behalf.

MDR and IVDR Transition Deadlines

• MDR legacy devices (Class III and implantable Class IIb): until 31 December 2027, if the conditions of Regulation (EU) 2023/607 are met
• MDR legacy devices (other classes): until 31 December 2028, under the same conditions
• IVDR Class D: until 31 December 2027; Class C: 31 December 2028; Class B and sterile Class A: 31 December 2029, under Regulation (EU) 2024/1860

The European Commission has also proposed changes to simplify MDR and IVDR. We follow these developments and update your obligations as the rules change. See also our CE marking and IVDR CE marking services.

How Our European Authorized Representative Services Work

1. Review – we confirm device classification and your conformity assessment route (MDR classification).
2. Mandate – we draft and sign the written mandate within 2–3 working days.
3. Document check – we verify your declaration of conformity, certificates and technical documentation.
4. EUDAMED – we complete actor registration and support your SRN and device registration.
5. Labelling – we provide the EU Representative name, address and symbol layout for your labels.
6. Ongoing support – authority requests, complaints, vigilance and Free Sale Certificates.

EU Representative Annual Fees (MDR / IVDR)

Mandate drafting and signing: 2–3 working days.

Have several devices or device groups? Request a custom proposal.

Why Choose MedDeviceCorp as Your EU Representative?

• Clear, fixed annual fees by device class
• Regulatory specialists who understand MDR, IVDR, EUDAMED and UDI
• Free Sale Certificates and attested EU Representative certificates for export registrations
• One team for EU Representative, UK Responsible Person and US FDA Agent services

EU Representative FAQs