IVDR Article 11: EC REP Joint Liability for Defective Devices

1. Key takeaways

For manufacturers with no establishment in a Member State, devices may be placed on the EU market only after the manufacturer has appointed a sole authorised representative (Article 11(1)). The appointment must constitute a mandate conferred on the authorised representative, is valid only once the authorised representative has accepted it in writing, and must cover at least all devices of the same generic device group (Article 11(2)). Article 11(5) goes a decisive step further: where a manufacturer not established in a Member State fails to fulfil its obligations under Article 10, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. In practical terms, appointing an EC REP is not a registered-address or mail-forwarding exercise; it transfers genuine exposure for defective-device liability. Mandate design, written acceptance, full task coverage under Article 11(3), and disciplined two-way information flows are therefore the core compliance levers for every non-EU manufacturer of in vitro diagnostic devices.

2. Legal basis

3. Expert insights

Insight 1: Joint and several liability is compensation liability, not a liaison service.

The wording of Article 11(5) states that the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. Once the mandate is signed, the authorised representative inherits the same compensation foundation as the manufacturer for defective-device claims, even though the device was designed, produced and released by the manufacturer abroad. A reading of the authorised representative as a European address plus a mail-forwarding service cannot be reconciled with this legal source. Manufacturers should therefore treat the choice of an EC REP as a risk-sharing decision: vet the partner financial standing, its insurance arrangements and its ability to handle claims, because claimants in the EU may approach the authorised representative directly, and under joint and several liability the authorised representative may be held to pay in full before recovering from the manufacturer.

Insight 2: Among the eight tasks of Article 11(3), items (c), (g) and (h) most often remain formalities.

The eight tasks are: (a) verify that the EU Declaration of Conformity and the technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out; (b) keep available for competent authorities the technical documentation, the Declaration of Conformity and, where applicable, a copy of the certificate under Article 51 for the period referred to in Article 10(7); (c) comply with the registration obligations under Article 28 and verify that the manufacturer has complied with the registration obligations under Article 26; (d) provide all information and documentation necessary to demonstrate conformity upon request; (e) forward any request from a competent authority for samples or device access and verify that it is granted; (f) cooperate with competent authorities on preventive or corrective actions; (g) immediately inform the manufacturer about complaints and reports of suspected incidents related to the designated devices; (h) terminate the mandate where the manufacturer acts contrary to its obligations under the Regulation. In practice, the two-way verification in (c), the immediate notification in (g) and the termination duty in (h) are the tasks most often unsupported by any documented process.

Insight 3: The non-delegable list draws the bottom line of manufacturer obligations.

Article 11(4) makes clear that the obligations in Articles 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11) may not be delegated through the mandate. Risk management, performance evaluation including performance evaluation follow-up, technical documentation, the Declaration of Conformity and CE marking, UDI and registration, the quality management system, post-market surveillance, information supplied with the device, and corrective actions remain with the manufacturer at all times. A mandate that purports to transfer these obligations wholesale to the authorised representative is legally ineffective to that extent and creates a false sense of security on both sides.

Insight 4: Article 15(6) requires the authorised representative to have a PRRC as well.

The authorised representative must have permanently and continuously at its disposal at least one person responsible for regulatory compliance (PRRC) with expert knowledge in the field of in vitro diagnostic medical devices in the European Union, meeting the same qualification routes as Article 15(1): a diploma plus one year of relevant experience, or four years of professional experience. When evaluating a prospective EC REP, request the qualifications of that person rather than judging the provider by its registered address alone, and verify that the PRRC remains available throughout the life of the mandate, not only at the signature stage.

4. Practical recommendations

1. Draft the mandate listing each of the eight tasks of Article 11(3) item by item, and state the scope of generic device groups covered.
2. Agree separately in the commercial contract on liability boundaries, information-notification deadlines, termination conditions and document handover, so the commercial layer does not drift away from the statutory joint and several liability.
3. Require the authorised representative to evidence the qualifications of its PRRC under the routes of Article 15(1)(a) or (b), and to keep the PRRC continuously available under Article 15(6).
4. Run a two-way ledger: the manufacturer pushes changes and incidents, and the authorised representative returns complaints and correspondence from authorities.
5. Review the mandate and the EUDAMED registration details once per year as a practical estimate, and record the review outcome.

5. Verification checklist

• □ Confirmed whether the manufacturer is established in a Member State (which decides whether an EC REP must be appointed)
• □ Mandate accepted in writing by the authorised representative (Article 11(2))
• □ Mandate covers the eight tasks of Article 11(3) and reaches at least the same generic device group
• □ Non-delegable obligations under Article 11(4) mapped into a list
• □ Verified that the authorised representative has a qualified PRRC under Article 15(6)
• □ Two-way information ledger and an annual review mechanism (practical estimate) in place

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, with mandate drafting, EUDAMED registration support and fee budgeting for notified body, EURL and Member State charges. For Article 11 liability and mandate support, contact info@grzanglobal.com.