MDR Article 11: What the EU Rep Mandate Must Cover

A manufacturer with no establishment in the EU cannot place a device on the Union market at all without first designating a sole Authorised Representative under Article 11 of the MDR. Most non-EU manufacturers treat that step as a procurement decision — pick a provider, sign their standard form, move on. The regulation does not treat it that way. Article 11 sets out, in a written mandate, exactly what the Authorised Representative must be empowered to do, and it ties liability to whether those minimum tasks are actually covered.

Why the mandate exists at all

The EU has no mechanism to inspect or sanction a manufacturer with no legal presence inside its borders. Article 11 closes that gap by requiring a Union-based party — the Authorised Representative — who can be reached, audited, and held accountable in the manufacturer's place. That is also why the role is not interchangeable with a distributor's general verification duties under economic operator obligations, or with the internal authority a PRRC holds inside the manufacturer's own organization. The Authorised Representative is the EU's point of contact for a manufacturer that, by definition, is not there.

What the mandate has to require, at minimum

Article 11(3) does not leave the content of the mandate to negotiation. It requires the manufacturer to enable, and the mandate to require, the Authorised Representative to perform a defined floor of tasks for every device the mandate covers:

• Verify the paperwork exists and was done properly. Confirm the EU declaration of conformity and technical documentation have been drawn up, and that the manufacturer carried out an appropriate conformity assessment procedure — before the device ships, not after an inspector asks.
• Keep the file available. Hold copies of the technical documentation, EU declaration of conformity, and any relevant certificate, available to competent authorities for the retention period set by the manufacturer's own Article 10 obligations.
• Answer the authority, not just the manufacturer. Respond to a competent authority's request with the information and documentation needed to demonstrate a device's conformity — the mandate has to give the Representative standing and access to do this without waiting on the manufacturer.
• Pass incident reports upstream immediately. Inform the manufacturer of complaints and reports from healthcare professionals, patients, and users concerning suspected incidents involving a covered device.
• Walk away from a non-compliant manufacturer. Terminate the mandate, and inform the competent authority, if the manufacturer acts contrary to its obligations under the regulation — a provision that only works if the mandate actually gives the Representative that exit.

The mandate is not a courtesy appointment. It is the only legal hook the EU has into a manufacturer that was never required to set foot there — so the document has to actually say what the regulation requires, not what a vendor's template happens to include. Why the task list matters more than the signature

The liability question buyers get wrong

The most common misreading of Article 11 treats the Authorised Representative as a shield — appoint one, and EU liability exposure is handled. Article 11(5) does not work that way. Where the manufacturer is not established in a Member State and has not complied with its Article 10 general obligations, the Authorised Representative becomes legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. The trigger is the manufacturer's own non-compliance, not the Representative's performance in isolation. A manufacturer with clean Article 10 compliance and a thin mandate is in a different, and in some ways more dangerous, position than one with a thorough mandate and open Article 10 gaps: the paperwork quality of the mandate does not substitute for the manufacturer actually meeting its own obligations first.

None of this is exotic work, but it is work that gets skipped when the Authorised Representative appointment is treated as a line item rather than a regulatory relationship. A mandate audited against Article 11(3), paired with a current Article 10 gap assessment, is a bounded exercise most manufacturers can complete well ahead of a notified body or competent authority asking for the document. For the broader set of duties that sit alongside the Authorised Representative's role, see our EU MDR & IVDR compliance work, and for the CE marking process the mandate ultimately supports, see CE marking strategy.