EU MDR Article 11(5): Authorised Representative Liability and Duties

1. Key takeaways

Under Article 11(1) of Regulation (EU) 2017/745 (the MDR), a manufacturer that does not have an establishment in a Member State may place its devices on the Union market only after designating a single authorised representative. The authorised representative must verify the EU declaration of conformity and the technical documentation, keep copies on file, verify that the manufacturer has completed its EUDAMED registration, and cooperate in corrective actions. Under Article 11(5), where a manufacturer that is not established in the Union fails to fulfil its obligations under Article 10, the authorised representative bears the same base of liability as the manufacturer, jointly and severally, for defective devices. This provision is the commercial core of the entire EC REP system. It converts an apparently administrative role into genuine product liability exposure, and it explains why serious authorised representatives review technical documentation before accepting a mandate, why mandates must be drafted against the task list in Article 11(3), and why manufacturers should treat the selection of their authorised representative as a compliance decision rather than a mailbox service. For any manufacturer without an establishment in the European Union, understanding this liability regime is the first step in planning an EU market entry that will withstand regulatory scrutiny.

2. Legal basis

The obligations and liability regime summarised above rest on the following instruments, which should be consulted directly when drafting or reviewing a mandate.

3. Expert insights

Insight one: joint liability is the core of the EC REP system and the foundation of both pricing and due diligence.

The joint liability in Article 11(5) arises when two conditions are met together: the manufacturer is not established in the Union, and it has failed to fulfil its obligations under Article 10. This means the authorised representative does not absorb procedural risk only; it takes on substantive exposure to product defect liability. The European Commission factsheet states the position plainly: the authorised representative is legally liable jointly with the manufacturer for defective devices. A responsible EC REP therefore reviews the technical documentation before signing the mandate. An organisation that signs without reviewing has, in practical terms, not understood what it is signing. For manufacturers, this insight cuts both ways. A representative that refuses to review documents is a warning sign, but so is a representative that accepts a mandate instantly and cheaply, because that pricing model is only sustainable if verification is never actually performed.

Insight two: the authorised representative must verify, not merely act as a document custodian.

The minimum obligations listed in Article 11(3) include: verifying that the EU declaration of conformity and the technical documentation have been drawn up and that, where applicable, an appropriate conformity assessment procedure has been carried out (Article 11(3)(a)); keeping available a copy of the technical documentation, the EU declaration of conformity and, if applicable, certificates, including any amendments and supplements, for inspection by competent authorities (Article 11(3)(b)); and complying with its own registration obligations under Article 31 and verifying that the manufacturer has complied with its registration obligations under Articles 27 and 29 (Article 11(3)(c)). A copy of documents that is never opened does not satisfy Article 11(3)(a). Verification means actually reading the declaration of conformity, checking that the technical documentation exists and is coherent, and confirming that the conformity assessment route claimed on the label matches the certificates held.

Insight three: Article 11(4) draws the boundary of what cannot be delegated.

Obligations related to design, the quality management system and the drawing up of technical documentation belong exclusively to the manufacturer and must not form part of the mandate. The purpose of this provision is to prevent commercial arrangements in which an entire compliance function is outsourced to the EC REP. When negotiating the scope of a mandate, manufacturers should treat any promise that the representative will write the technical documentation as conflicting with Article 11(4) on its face. Such a promise is not a value-added service; it is a structural non-compliance that would undermine the validity of the mandate itself and could expose both parties in a market surveillance inspection.

Insight four: the authorised representative has a statutory duty to terminate the mandate.

Under Article 11(3)(h), where the manufacturer breaches its obligations, the authorised representative must terminate the mandate and immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body involved in the conformity assessment of the device, indicating the reason for the termination. This duty explains why an EC REP will actively review documents and may unilaterally withdraw from the cooperation. It also means the mandate should anticipate termination: manufacturers should agree in advance on how documents, registrations and ongoing obligations will be handled if the representative exercises this statutory exit right, so that a termination does not leave the devices on the market without a validly designated representative.

4. Practical recommendations

1. When selecting an EC REP, include in the due diligence checklist whether it has a PRRC, who the PRRC is and who the deputy is (Article 15(6)).
2. Compare the mandate clause by clause against the task list in Article 11(3), and expressly exclude the non-delegable matters of Article 11(4).
3. When delivering technical documentation and certificates to the EC REP, keep a delivery list with version numbers so that the verification obligation leaves an auditable trail.
4. Establish a channel with the EC REP for immediate notification of complaints and suspected incidents, and test reachability outside working hours.
5. State in the commercial contract that the fulfilment by the manufacturer itself of its Article 10 obligations is the precondition for the liability arrangement with the EC REP.

5. Verification checklist

Before relying on the designation, walk through the following items and record the evidence for each.

• □ A single EC REP has been designated (Article 11(1))
• □ The mandate has been accepted in writing and covers the same group of generic devices (Article 11(2))
• □ The mandate has been compared clause by clause against the task list of Article 11(3)
• □ The mandate expressly excludes the non-delegable matters of Article 11(4)
• □ It is confirmed that the EC REP has a qualified PRRC in place (Article 15(6))
• □ An immediate notification channel for complaints and suspected incidents is established
• □ Technical documentation and certificates have been delivered to the EC REP and a delivery list is retained

Regulatory information verified as of 29 October 2026.

GRZAN supports medical device manufacturers entering the European Union market under the EU MDR, offering appointment as EU Authorised Representative (AR) and Person Responsible for Regulatory Compliance (PRRC), verification of declarations of conformity and technical documentation, EUDAMED registration support, and fee and budget planning for notified body conformity assessment. Our team helps manufacturers without an establishment in the Union meet their obligations under Regulation (EU) 2017/745, from mandate drafting under Article 11 to readiness for market surveillance and inspections. For practical support with authorisation, registration and budget matters, contact GRZAN at info@grzanglobal.com.