IVDR Authorised Representative Mandate: The Eight Tasks Under Article 11(3)

1. Key takeaways

The mandate is the source of authority and the boundary of responsibility for the authorised representative. Article 11(3) requires the mandate to at least require and enable the authorised representative to perform the eight tasks (a)–(h); Article 11(4) states that the obligations in paragraphs (1), (2), (3), (4), (5), (6), (8), (9), (10) and (11) of Article 10 may not be delegated. The authorised representative must provide a copy of the mandate to a competent authority upon request (final subparagraph of Article 11(3), first paragraph). A mandate drafted around these boundaries is the single document that determines whether the EC REP relationship is legally sound: it fixes the scope of tasks, embeds the ten-year retention period by reference to Article 10(7), makes the non-delegable list explicit, and defines the triggers that would force the authorised representative to terminate the mandate if the manufacturer breaches the Regulation.

2. Legal basis

3. Expert insights

Insight 1: At least means the mandate may say more, but never less.

The second subparagraph of Article 11(3) reads: the mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks. The word at least sets a floor, not a ceiling. In practice, two additions are commonly needed: the medium and duration agreed for document custody, and the response deadlines within which the manufacturer must supply information to the authorised representative. Neither belongs to the eight tasks as such, yet both decide whether those tasks can actually be performed. A mandate that stops at the statutory minimum leaves the operational mechanics undefined, and disputes about who holds which document, or how fast the manufacturer must respond to a request from a competent authority relayed by the EC REP, tend to surface exactly when the relationship is under stress. Adding the two clauses costs nothing at signature and prevents the most common operational deadlock: the EC REP cannot discharge task (d) or (e) because the manufacturer has never agreed a response deadline for providing the requested documentation.

The same logic applies on the manufacturer side of the equation. Article 11(3) says the manufacturer shall enable the authorised representative to perform the tasks, and enabling means more than paying the service fee: it means granting access to the technical documentation, the Declaration of Conformity, certificate copies and the complaint and incident records needed for tasks (a), (b), (d), (g) and (h). A mandate should therefore also allocate the systems through which this access happens, for example a shared repository or a defined email channel with agreed formats, so that both parties can evidence performance of the tasks if a competent authority asks how the arrangement works in practice.

Insight 2: Task (b) points directly to the ten-year retention period of Article 10(7).

Article 11(3)(b) requires the authorised representative to keep the technical documentation, the EU Declaration of Conformity and, where applicable, a copy of the certificate issued under Article 51, including revisions and supplements, available for competent authorities for the period referred to in Article 10(7). That period is at least 10 years from the last device covered by the Declaration of Conformity being placed on the market. Writing this figure directly into the mandate avoids later arguments about custodial scope, especially when the relationship ends mid-way and handover dates must be reconstructed.

Insight 3: The boundary of the non-delegable list is that liability can be shared, but obligations cannot be transferred.

The ten exclusions of Article 11(4) cover: conformity of design and manufacture (10(1)); the risk management system (10(2)); performance evaluation including performance evaluation follow-up (10(3)); technical documentation (10(4)); the Declaration of Conformity and CE marking (10(5)); UDI and registration obligations (10(6)); the quality management system (10(8)); the post-market surveillance system (10(9)); information supplied with the device and its languages (10(10)); and corrective actions and notifications (10(11)). The authorised representative may assist in executing these duties, but the obligated party remains the manufacturer. Any clause describing these obligations as delegated to the EC REP is void to that extent.

Insight 4: The termination duty of Article 11(3)(h) needs internal triggers.

Article 11(3)(h) requires the mandate to provide that the authorised representative shall terminate the mandate where the manufacturer acts contrary to its obligations under the Regulation; Article 11(6) further requires that, upon termination, the authorised representative immediately notify the competent authority of the Member State in which it is established and, where applicable, the notified body involved in conformity assessment for the device, stating the reasons. The mandate should spell out which situations constitute a trigger, for example a refusal to address a serious complaint, failure to maintain the quality management system, or persistent non-response to incident reports. Without defined triggers, the termination clause remains an abstract promise that cannot be executed cleanly.

4. Practical recommendations

1. Number the eight tasks of Article 11(3) item by item in the mandate, and add clauses on document custody, information response deadlines and fee arrangements.
2. State expressly the 10-year retention period of Article 10(7) and the duty to cooperate in document retrieval.
3. List the non-delegable obligations of Article 11(4) separately, avoiding any wording of blanket delegation.
4. Agree termination triggers and, after termination, the document handover and EUDAMED information update arrangements (Article 11(6)).
5. Review the consistency of the mandate with EUDAMED registration and certificate status once per year as a practical estimate.

5. Verification checklist

• □ Mandate covers the eight tasks (a)–(h) of Article 11(3) item by item
• □ The at least 10-year document retention period of Article 10(7) written in (Article 11(3)(b))
• □ The list of non-delegable manufacturer obligations under Article 11(4) stated expressly
• □ Termination triggers and notification arrangements agreed (Articles 11(3)(h) and 11(6))
• □ The authorised representative confirmed it can provide a mandate copy upon request from a competent authority
• □ Annual consistency review mechanism (practical estimate) established

Legal information verified as of 2026-10-29.

GRZAN supports in vitro diagnostic manufacturers entering the EU market under Regulation (EU) 2017/746 as EU Authorised Representative (EC REP) and PRRC provider, including mandate design against Articles 11(3) and 11(4), EUDAMED registration support and fee budgeting. For mandate drafting and review, contact info@grzanglobal.com.