The eight duties an EU mandate has to name

A manufacturer outside the EU appointing an authorized representative often treats the paperwork behind that appointment as a formality — a signature block on a services agreement, done. MDR Article 11 doesn't leave it there. It requires a written mandate the representative has to accept before acting, and Article 11(3) doesn't leave what that mandate has to say open to negotiation: it names eight specific tasks, lettered (a) through (h), the mandate has to assign one by one. A mandate that authorizes the representative to ‘act on the manufacturer's behalf’ in general terms, without naming those eight tasks individually, hasn't satisfied the article that created the role.

Eight tasks, not a general power of attorney

Article 11(3) requires the mandate to specify, at minimum, that the representative shall: verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out (a); keep a copy of the technical documentation, the declaration of conformity and any relevant certificate available to competent authorities for the retention period Article 10(8) sets (b); comply with the registration obligations in Article 31 (c); respond to a competent authority's request with the information and documentation needed to demonstrate a device's conformity (d); forward to the manufacturer any competent-authority request for samples or access to a device, and confirm the authority actually receives them (e); cooperate with competent authorities on any preventive or corrective action (f); immediately inform the manufacturer of complaints and reports of suspected incidents (g); and terminate the mandate if the manufacturer acts contrary to its obligations under the Regulation (h). A mandate document that authorizes the role generically and never assigns these eight by name has skipped the actual content Article 11(3) requires the agreement to carry.

Task (a) is where the representative's own exposure starts

Article 11(5) attaches real consequence to how seriously task (a) gets performed: where the manufacturer is not established in a Member State and hasn't complied with its own Article 10 obligations, the representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. That's not a penalty for bad luck — it's the structural cost of a verification task the representative agreed to perform under (a) and then didn't perform closely enough to catch what a competent authority later found. A representative that treats task (a) as a box to check on receipt of a folder, rather than a genuine review of the declaration and the technical documentation behind it, is carrying liability exposure it hasn't actually priced.

Termination is a duty, not just an exit clause

Task (h) reads like an ordinary contract exit right until the paragraph that follows it: a representative that terminates the mandate on that ground has to immediately inform the competent authority in its own Member State, and the notified body involved in the device's conformity assessment where one exists, of the termination and its reasons. An ordinary services agreement lets either party walk away without explaining why to a third party. Article 11(3)(h) turns that same exit into a regulatory notification the representative owes to two separate authorities, not just a clause it can invoke quietly.

The mandate has to work alongside the representative's own PRRC

A separate requirement sits next to the mandate rather than inside it: Article 15(2) requires the representative itself, not just the manufacturer, to have permanently and continuously available at least one person responsible for regulatory compliance possessing the requisite expertise in the EU's regulatory requirements for devices — a different, less prescriptive qualification test than Article 15(1) sets for the manufacturer's own PRRC, which asks for a specific diploma-plus-experience or four-year-experience combination. A mandate built without reference to who, on the representative's side, actually carries out tasks (a) through (h) — and how that work relates to the representative's own PRRC obligation under 15(2) — has left a structural question unanswered that the regulation asks two different articles to cover.

Where the mandate's tasks meet the rest of the file

Task (b)'s copy of the technical documentation is the same file a design file has to structure around Annex II for the manufacturer's own use — the representative's copy has to stay current against the same document, not a snapshot taken once at appointment. And task (g)'s duty to relay complaints and suspected-incident reports immediately is the representative's entry point into the same vigilance clock a serious incident report runs against once a report actually crosses the reporting threshold — a mandate that doesn't specify how quickly ‘immediately’ has to mean in practice is leaving the representative to guess at a clock the manufacturer's own vigilance system may already be running against.

A written-mandate worksheet built around the eight named tasks, the Article 11(5) liability trigger, and the representative's own Article 15(2) PRRC obligation is previewed in the launch catalog. If your program's mandate assigns these differently, the shelf takes that correction directly.