EU MDR Authorised Representative Mandate: Requirements Under Article 11(2)

1. Key takeaways

Under Article 11(2) of the MDR, the mandate that constitutes the designation of an authorised representative is valid only once it has been accepted in writing by the authorised representative, and it must cover at least all devices in the same group of generic devices. The content of the mandate must span the task list in Article 11(3) and must not include the matters listed in Article 11(4) relating to design, the quality management system and the drawing up of technical documentation. These three formal requirements operate cumulatively: an unsigned letter of intent, an oral arrangement or a mandate covering only part of a model list fails Article 11(2). The mandate is therefore both a legal instrument and a working contract, and it should be drafted so that a competent authority can trace every clause to a specific paragraph of Article 11(3), while the non-delegable items are carved out explicitly rather than left to interpretation. Getting the document right at signature avoids costly renegotiations later and gives both the manufacturer and the representative a clear map of who verifies what, who keeps which copies and who notifies whom when something goes wrong in the supply chain.

2. Legal basis

The validity requirements and boundaries of the mandate derive from the following provisions of Regulation (EU) 2017/745 and the associated Commission guidance.

3. Expert insights

Insight one: the three formal requirements of the mandate are cumulative and none can be skipped.

Article 11(2) sets out three elements: first, the mandate must be accepted in writing by the authorised representative; second, the mandate must cover at least all devices in the same group of generic devices; and third, it is the mandate itself that constitutes the designation of the authorised representative. Oral arrangements, unsigned letters of intent and mandates that cover only part of a model list do not satisfy Article 11(2). In practice, the second element is the one most often mishandled: manufacturers add new models to a device group over time and forget to extend the mandate, leaving a device on the market that is technically outside the written designation. A well-drafted mandate therefore defines the device group by reference to the generic group rather than by a frozen list of catalogue numbers, or includes a mechanism for notifying additions within the same group.

Insight two: the task list in Article 11(3) is a minimum requirement, not optional recommended clauses.

Article 11(3) enumerates the minimum tasks the authorised representative must be able to perform: verifying the EU declaration of conformity and the technical documentation, keeping copies available, verifying the manufacturer’s registrations under Articles 27 and 29, providing a competent authority with all the information and documentation necessary to demonstrate conformity, cooperating with preventive and corrective actions, immediately informing the manufacturer about complaints and reports of suspected incidents, and terminating the mandate where the manufacturer breaches its obligations. The mandate may agree to more, but never to less. When reviewing a draft mandate, count the tasks: if the representative’s service description does not map onto each subparagraph of Article 11(3), the gap is not a commercial issue but a regulatory one, and the designation may not achieve its legal purpose.

Insight three: Article 11(4) is a negative list of matters that cannot be delegated.

The manufacturer obligations related to device design, the quality management system and the drawing up of technical documentation must not be included in the mandate. If a negotiation produces a promise that the EC REP will take care of the technical documentation end to end, that promise signals either an organisation that does not understand Article 11(4) or one that does not intend to genuinely perform the verification duties of Article 11(3) — and both situations should be treated as risk signals rather than conveniences. Manufacturers should add a dedicated chapter to the mandate that cites Article 11(4) and records that neither party will perform or accept such delegated activities.

Insight four: termination clauses must be designed in both directions.

Article 11(3)(h) establishes the statutory duty of the authorised representative to terminate unilaterally and the subsequent notification duty (informing the competent authority of the Member State in which it is established and, where applicable, the notified body). At the commercial contract level, the parties should additionally agree on the manufacturer’s right of withdrawal, the return of documents, the handling of registration data and transitional arrangements, aligned with the change procedure in Article 12. A mandate that only addresses the representative’s statutory exit leaves the manufacturer without a route to change representatives smoothly, and a mandate that only addresses commercial withdrawal ignores the statutory notification duty that still applies.

4. Practical recommendations

1. Draft the mandate with the task list numbered item by item, mapped one to one onto Article 11(3), so that competent authorities can verify it without interpretation.
2. Add a dedicated chapter on non-delegable matters, citing Article 11(4) and expressly agreeing that neither party will engage in such activities.
3. Agree on a document delivery list, version control and the triggers for updates (certificate revisions, technical documentation updates).
4. Agree on the notification path and timelines after termination, consistent with Article 11(3)(h).
5. Write the change-of-representative arrangements under Article 12 into a contract annex in advance, to avoid a vacuum period during a change.

5. Verification checklist

Use the following items to confirm the mandate is complete before signature and renewal.

• □ The mandate has been accepted in writing by the authorised representative (Article 11(2))
• □ The mandate covers all devices in the same group of generic devices
• □ The mandate corresponds item by item to the task list of Article 11(3)
• □ A dedicated chapter excludes the non-delegable matters of Article 11(4)
• □ The notification path and timelines after termination are agreed (Article 11(3)(h))
• □ The change arrangements under Article 12 are written into a contract annex

Regulatory information verified as of 29 October 2026.

GRZAN assists manufacturers with EU MDR market entry by acting as EU Authorised Representative (AR) and Person Responsible for Regulatory Compliance (PRRC), reviewing and accepting mandates that map onto the task list of Article 11(3), excluding non-delegable matters under Article 11(4), and supporting EUDAMED registration and notified body fee and budget planning. Our team drafts and reviews mandate documents, verification workflows and change-of-representative annexes so that manufacturers without an establishment in the European Union remain inspection-ready under Regulation (EU) 2017/745. For practical support with mandates, registration and budget matters, contact GRZAN at info@grzanglobal.com.