EU MDR Economic Operators: Authorised Representative, Importer, Distributor and PRRC

Under the EU MDR, putting a device on the market is no longer the manufacturer’s job alone. The regulation assigns defined responsibilities to every organisation in the supply chain, including the authorised representative, the importer and the distributor, plus a person responsible for regulatory compliance inside the manufacturer or the authorised representative. These are called economic operators, and each one can be held accountable by competent authorities. This guide explains who they are, what each must do, and how to keep the responsibilities clear, whether you are a manufacturer outside the EU or a company that sells devices in Europe.

The economic operators at a glance

Operator	MDR article	Role in one sentence
Manufacturer	Article 10	Designs and manufactures the device, or has it designed or manufactured, and markets it under its own name or trademark; carries overall responsibility for conformity
Authorised representative	Article 11	Represents a non-EU manufacturer in the EU under a written mandate
Importer	Article 13	Places a device from a third country on the EU market
Distributor	Article 14	Makes a device available on the market, other than the manufacturer or importer
System or procedure pack producer	Article 22	Combines CE-marked devices into a system or procedure pack

Manufacturer: the baseline duties

The manufacturer remains responsible for classification, conformity assessment, technical documentation, the EU declaration of conformity, CE marking, the quality management system, post-market surveillance, vigilance and registration of the device and itself in EUDAMED. The manufacturer must also designate a person responsible for regulatory compliance (PRRC). Our guides to technical documentation and post-market surveillance cover those obligations in detail.

Authorised representative (Article 11)

A manufacturer located outside the EU must appoint a single authorised representative for each device it places on the EU market, and the appointment must be in writing under a mandate. The authorised representative’s minimum tasks include:

• verifying that the EU declaration of conformity and technical documentation have been drawn up and that an appropriate conformity assessment has been carried out;
• keeping the declaration and technical documentation, and relevant certificates, available for competent authorities;
• complying with registration obligations for the device and the manufacturer;
• on request, providing authorities with information and documentation, and cooperating on corrective action;
• forwarding complaints and reports of suspected incidents from healthcare professionals, patients and users to the manufacturer;
• terminating the mandate if the manufacturer acts contrary to its obligations, and informing the authority and notified body.

Importantly, an authorised representative is legally jointly and severally liable with the manufacturer for defective devices, which is why careful selection and a clear mandate matter. The authorised representative must also have a PRRC available.

Importer (Article 13)

An importer may place only compliant devices on the EU market. Before doing so, the importer must verify that:

• the device has a CE mark and the EU declaration of conformity has been drawn up;
• the manufacturer is identified and an authorised representative has been designated;
• the device is labelled correctly and accompanied by the required instructions for use;
• the manufacturer has assigned a UDI where required.

The importer must indicate its name, registered trade name or trademark, registered place of business and address on the device, its packaging or a document accompanying the device, and make sure that any additional label does not obscure the manufacturer’s information. Importers must also verify registration in the electronic system, keep a register of complaints, non-conforming devices, recalls and withdrawals, ensure storage and transport conditions maintain compliance, and cooperate with authorities. If an importer believes a device is non-compliant, it must not place it on the market until it is brought into conformity.

Distributor (Article 14)

Before making a device available, the distributor must verify that the device bears the CE mark, that the declaration of conformity and instructions for use are supplied, that the device is labelled in the required language, that the manufacturer (and importer, where relevant) have complied with their obligations, and that a UDI has been assigned. Distributors must also keep storage and transport conditions within the manufacturer’s requirements, keep a register of complaints and non-conforming devices, and inform the manufacturer, authorised representative and importer of incidents and complaints. Where a distributor believes a device is not in conformity, it must not make the device available.

When a distributor or importer becomes the manufacturer (Article 16)

A distributor, importer or other person takes on the manufacturer’s obligations if they place a device on the market under their own name, trade name or trademark, change the intended purpose of a device already on the market, or modify a device in a way that may affect conformity. Private-label arrangements are therefore a frequent source of regulatory risk, because the “own brand labeler” needs a full QMS, technical documentation access and a PRRC. Contracts between the parties should state clearly who holds each obligation.

Person responsible for regulatory compliance (Article 15)

Each manufacturer and authorised representative must have at least one PRRC available. The PRRC is responsible for, among other things, checking that devices are conforming before release, that technical documentation and the declaration of conformity are up to date, that post-market surveillance and vigilance obligations are met, and that statements for investigational devices are issued. Required qualifications are a relevant university degree (for example in law, medicine, pharmacy or engineering) plus at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices, or four years of such experience without the degree. Micro and small enterprises may have a PRRC “permanently and continuously at their disposal” rather than employing one, but a manufacturer’s own organisation must still be able to demonstrate control. If you want the skills behind this role, see our regulatory affairs certificate course.

Registration and traceability

Economic operators register in EUDAMED and receive a single registration number (SRN), which links them to the devices they handle. Manufacturers and authorised representatives register first; importers register their activities. Traceability depends on UDI and on keeping records of who supplied and received each device. The UDI guide explains how identifiers work, and the recall guide shows why distribution records matter when a field action begins.

Practical checklist for each role

1. Write a quality agreement that allocates responsibilities and communication channels between manufacturer, authorised representative, importer and distributors.
2. Verify CE marking, declarations of conformity, labeling and UDI on receipt of each batch.
3. Set up a joint complaint and incident escalation route with defined timelines.
4. Keep records for the required retention period, which is at least 10 years after the last device is placed on the market, or 15 years for implantable devices.
5. Agree who holds technical documentation and how authorities obtain it quickly.
6. Review the contract whenever a brand, label, intended purpose or supplier changes.

Common mistakes

• Appointing an authorised representative without checking its capacity, competence and PRRC availability.
• Importers relabeling products without realising they may have become the manufacturer.
• Failing to verify UDI and EUDAMED registration on receipt.
• Relying on verbal arrangements instead of a written mandate or quality agreement.
• Distribution records that cannot identify customers quickly during a field action.

Frequently asked questions

Does every non-EU manufacturer need an authorised representative?

Yes, where the manufacturer is not established in a Member State, it must designate a single authorised representative for the devices it places on the EU market, with a written mandate.

Can a distributor also be an importer?

A company can hold both roles for different products, but the obligations are distinct. When it brings devices from outside the EU onto the market it is acting as an importer and must meet the importer duties.

Is the authorised representative responsible for the technical documentation?

The manufacturer produces the documentation. The authorised representative must verify that it exists and keep it available for authorities, according to the mandate.

What if my distributor adds its own brand?

If a distributor places the device on the market under its own name or trademark, it takes on the manufacturer’s obligations unless it has an agreement with the original manufacturer that meets the MDR conditions. Seek legal and regulatory advice before agreeing to private labeling.

The MDR and its guidance are updated through corrigenda and MDCG documents. Confirm current article text and guidance before relying on this summary in a contract or a compliance decision.

Related reading

• EU MDR and IVDR explained: the full regulatory map.
• Regulatory strategy for US and EU market entry: sequencing and readiness.
• Supplier controls and purchasing: managing the extended supply chain.
• Why teams struggle with EU MDR compliance: common pitfalls and fixes.

Talk to the AptSkill team

Want training in EU MDR roles, technical documentation or post-market duties? Send us your role and goal.