Is an EU authorised representative liable for defective devices?

It can be, but only in defined circumstances. MDR Article 11(5) makes the authorised representative legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10. If the manufacturer has met those obligations, the provision does not apply.

What does jointly and severally liable mean for an authorised representative?

It means an injured person may claim the whole of the loss from the manufacturer, from the authorised representative, or from both, rather than having to divide the claim between them. It does not decide who ultimately bears the loss. Rights of contribution and recourse between the two remain governed by national civil law and by whatever the mandate says about indemnity.

Does authorised representative liability apply if the manufacturer is fully compliant?

No. Article 11(5) has two cumulative conditions: the manufacturer must be established outside the Union and must have failed to comply with Article 10. Article 10 covers the quality and risk management systems, technical documentation, conformity assessment, the EU declaration of conformity, UDI assignment, post-market surveillance and vigilance. Where those obligations are met, the Article 11(5) trigger is not engaged.

Does the MDR require an authorised representative to hold liability insurance?

The MDR places the financial coverage duty on the manufacturer, not on the authorised representative. Article 10(16) requires manufacturers to have measures in place providing sufficient financial coverage for their potential liability under Directive 85/374/EEC, proportionate to risk class, device type and enterprise size. No figure or specific insurance product is prescribed, and the Regulation sets no separate insurance requirement for representatives.

What does the new Product Liability Directive say about authorised representatives?

Directive (EU) 2024/2853 names the authorised representative directly. Article 8(1)(c) makes the importer, the authorised representative and, in their absence, the fulfilment service provider liable where the manufacturer of the product or component is established outside the Union. Article 12(1) allows two or more liable economic operators to be held liable jointly and severally. It applies to products placed on the market or put into service after 9 December 2026.

When must an authorised representative terminate the mandate?

Article 11(3)(h) requires the mandate to include terminating it if the manufacturer acts contrary to its obligations under the Regulation. It is drafted as a task the representative must be able and required to perform, not as a discretionary right, so a documented escalation process and clear termination wording in the mandate are worth having before the situation arises.

Authorised representative liability under MDR Article 11(5) explained

Q: Who must be informed when an authorised representative terminates a mandate?

Article 11(6) requires the representative to immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device, giving the reasons for termination. Where no notified body was involved, as with self-certified class I devices, the competent authority alone is notified.

6 days ago

7 min read

Authorised representative liability under MDR 2017/745 is real, but it is conditional. Article 11(5) makes the EU authorised representative legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer, but only where the manufacturer is established outside the Union and has not complied with the general obligations in Article 10. It is not a blanket guarantee of the manufacturer's products, and it does not turn the authorised representative into the manufacturer.

That conditionality matters commercially. A manufacturer that keeps its Article 10 house in order does not expose its representative to Article 11(5) at all, which makes a mandate negotiation a conversation about compliance evidence rather than about insurance limits.

What Article 11(5) says about authorised representative liability

The provision is a single sentence:

"Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." (MDR Art. 11(5))

Three phrases carry the weight. Legally liable for defective devices points at liability for damage caused by a defect, not at every administrative shortcoming and not at the penalties Member States set under Article 113. On the same basis as measures the representative against the standard the manufacturer itself would face. Jointly and severally means an injured person may pursue the manufacturer, the representative, or both, for the whole of the loss.

Recital 35 explains the reasoning. It describes the authorised representative as playing a pivotal role for manufacturers not established in the Union, and then records that "The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer." (MDR Recital 35)

The two conditions that have to be met

Article 11(5) is not free-standing. It applies only where both limbs are satisfied: the manufacturer is not established in a Member State, and it has not complied with the obligations laid down in Article 10. Article 10 is the manufacturer's own chapter of duties, covering the quality and risk management systems, the technical documentation, conformity assessment, the EU declaration of conformity, UDI assignment, post-market surveillance and vigilance. Where those obligations have been met, the trigger in Article 11(5) has simply not been pulled.

It is worth being precise about what joint and several liability does. It governs the claimant's route to a defendant; it does not fix the final allocation of loss between co-defendants. Contribution and recourse remain a matter of national civil law and of what the parties agreed in writing, which is why a mandate should address indemnity expressly. The general duties an authorised representative signs up to are set out in our guide to MDR Article 11.

What the mandate cannot move: Article 11(4)

"The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)." (MDR Art. 11(4))

The non-delegation rule cuts both ways. An authorised representative never becomes a substitute manufacturer: it cannot lawfully take over the quality management system, the conformity assessment or the post-market surveillance plan, and no mandate clause can transfer them. But Article 11(5) opens without prejudice to paragraph 4, so the fact that those obligations could not be delegated is not itself a defence to the defective-device liability.

Article 10(16) and the manufacturer's financial coverage

Article 10(16) is the counterweight that mandate discussions often overlook. Its first subparagraph confirms the underlying right: "Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law." (MDR Art. 10(16))

Its second subparagraph places a duty on the manufacturer, not on the representative: "Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law." (MDR Art. 10(16))

The Regulation sets no figure and prescribes no particular insurance product; the test is proportionality to risk class, device type and enterprise size. For anyone assessing authorised representative liability before signature this is the most useful item in the file, because where a manufacturer sits outside the EU and its coverage is thin, the representative is the co-defendant a claimant can most easily reach. Asking for evidence of those measures is ordinary prudence.

Directive (EU) 2024/2853 names the authorised representative directly

The picture changes shape at the end of 2026. Under Directive 85/374/EEC the persons treated as producers are the manufacturer, the own-brander and the importer into the Community; an authorised representative is not named at all, which is precisely the gap MDR Article 11(5) was written to close. That directive has its own joint-and-several rule in Article 5, but it reaches only the persons it makes liable.

The new Product Liability Directive is explicit. Article 8(1) lists the economic operators liable for defective products, and point (c) covers the case of "in the case of a manufacturer of a product or a component established outside the Union, and without prejudice to the liability of that manufacturer:" It then names, in turn, the importer of the defective product or component, "the authorised representative of the manufacturer" and, where there is no importer established within the Union or authorised representative, the fulfilment service provider. (Directive (EU) 2024/2853 Art. 8(1)(c))

Article 12(1) supplies the joint-and-several mechanism: "Without prejudice to national law concerning rights of contribution or recourse, Member States shall ensure that where two or more economic operators are liable for the same damage pursuant to this Directive, they can be held liable jointly and severally." (Directive (EU) 2024/2853 Art. 12(1))

Two dates govern the changeover. "This Directive shall apply to products placed on the market or put into service after 9 December 2026." (Directive (EU) 2024/2853 Art. 2(1)) And "Directive 85/374/EEC is repealed with effect from 9 December 2026. However, it shall continue to apply with regard to products placed on the market or put into service before that date." (Directive (EU) 2024/2853 Art. 21) Because this is a directive and not a regulation, the operative detail will sit in national transpositions, due by the same date, and Member States may differ on procedural questions such as limitation periods.

Instrument	Is the authorised representative a liable party?	Condition	Applies to
MDR 2017/745 Art. 11(5)	Yes, for medical devices	Manufacturer outside the Union and not compliant with Article 10	Devices covered by the mandate, before and after 2026
Directive 85/374/EEC	Not named; producer, own-brander and importer are	Claimant proves damage, defect and causal relationship	Products placed on the market or put into service before 9 December 2026
Directive (EU) 2024/2853	Yes, named in Art. 8(1)(c)(ii)	Manufacturer of the product or component established outside the Union	Products placed on the market or put into service after 9 December 2026

The direction of travel is clear rather than dramatic. From 9 December 2026 an authorised representative is a designated liable operator under general product liability law for products of manufacturers established outside the Union, alongside the device-specific route in Article 11(5). What changes is the number of legal routes, not the day-to-day work of holding a compliant mandate.

Terminating the mandate: Article 11(3)(h) and Article 11(6)

The MDR does not leave an authorised representative trapped in a mandate that has gone wrong. Termination is one of the minimum tasks the mandate must require, under Article 11(3)(h): "terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation." (MDR Art. 11(3)(h))

It is drafted as a duty rather than an option: no representative should keep lending its name and its EU address to a device file it knows to be non-compliant. What follows termination is equally specific:

"An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor." (MDR Art. 11(6))

Three points follow. The notification goes to the competent authority of the Member State in which the representative is established, not the manufacturer's home authority. The notified body is informed only where one was involved in the conformity assessment, so self-certified class I devices usually involve the competent authority alone. And the reasons must be given, which is why a written record of the escalation that preceded termination is worth keeping. Where a manufacturer is simply moving to a different representative, Article 12 governs the handover; see our note on a change of authorised representative.

What authorised representative liability means when a manufacturer asks you to accept a mandate

Article 11(2) sets the starting point: "The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group." (MDR Art. 11(2))

Written acceptance creates the relationship, so everything worth checking is best checked before signature. A proportionate pre-mandate review asks whether the technical documentation and the EU declaration of conformity exist and can be inspected; whether any required certificate is current and covers every device in the generic device group offered; whether vigilance and post-market surveillance procedures are staffed; whether the Article 10(16) coverage measures can be evidenced; and whether the mandate sets out escalation, recourse and termination clearly enough to be used.

None of this should read as alarming. Authorised representatives who ask for documentation before signature are doing what the Regulation assumes they will do, and the same diligence that limits authorised representative liability also protects the manufacturer's route to market. Risk class and portfolio size shape how deep the review goes, which is why class-based annual pricing follows the same logic.

Where Medex fits

Medex acts as an EU authorised representative under EUDAMED SRN TR-AR-000057550, with a person responsible for regulatory compliance in-house and offices in Ankara, Istanbul and Gdansk. We perform the Article 11 mandate tasks and the pre-mandate documentation review described above; we do not carry out notified body conformity assessment, we do not write clients' technical documentation, and we do not find local distributors.