Does an EU authorised representative mandate have to be a separate contract?

No. MDR Article 11(2) requires a written designation accepted in writing by the representative, but it does not prescribe the contractual form. MDCG 2022-16 confirms the parties may configure their contractual relationship as they see appropriate, provided a written mandate exists that meets the Article 11(3) minimum and whose content is agreed. In practice the mandate is usually one signed agreement covering scope, tasks, documentation access, fees and termination.

Can a manufacturer exclude any of the Article 11(3) tasks from the mandate?

No. Article 11(3) says the mandate shall require the representative to perform at least the listed tasks, so points (a) to (h) form a floor. A mandate that omits one of them, or that makes the representative's right to terminate under point (h) subject to manufacturer approval, is not compliant. Competent authorities can ask for a copy of the mandate under Article 11(3) and check exactly this.

What language must the EU authorised representative mandate be written in?

MDR sets no language for the mandate itself, so English is common between a non-EU manufacturer and its representative. Article 11(3)(d) does require information and documentation demonstrating conformity to be supplied to an authority in an official Union language determined by the Member State concerned. Because an authority may request the mandate, it is prudent to agree in advance who provides translations and pays for them.

Can one mandate cover only some of a manufacturer's devices?

It can cover part of a portfolio, but not part of a generic device group. Article 11(2) requires the mandate to be effective at least for all devices of the same generic device group, defined in Article 2(7). A manufacturer may therefore appoint different representatives for different generic device groups, but only one sole representative per group under Article 11(1).

Who can terminate an EU authorised representative mandate?

Either party may terminate on the commercial terms they agreed, and Article 11(3)(h) additionally gives the representative a right to terminate if the manufacturer acts contrary to its obligations under the Regulation. Where termination happens on that ground, Article 11(6) obliges the representative to immediately inform its Member State competent authority and, where applicable, the notified body involved, together with the reasons.

Does the mandate transfer legal responsibility away from the manufacturer?

No. Article 11(4) states the mandate shall not delegate the manufacturer's obligations under Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12), which covers design, risk management, clinical evaluation, technical documentation, the declaration of conformity, CE marking, UDI and registration, the quality system, post-market surveillance, information supplied and corrective action. The representative may assist with those tasks but does not assume them.

Does the manufacturer have to give the representative access to the technical file?

Yes. The third subparagraph of Article 10(8) requires a manufacturer with a registered place of business outside the Union to ensure the representative has the necessary documentation permanently available, so it can perform the Article 11(3) tasks. MDCG 2022-16 reads that as constant access, in the most recent versions, by electronic or physical storage. The mandate should name the repository and the update process.

EU authorised representative mandate: what the Article 11 agreement must contain

6 days ago

7 min read

What an EU authorised representative mandate actually is

An EU authorised representative mandate is the written contract by which a manufacturer established outside the Union appoints one person inside the Union to carry out named regulatory tasks on its behalf, and it only comes into existence once that person has accepted it in writing. MDR 2017/745 prescribes no template, but Article 11(3) fixes eight tasks every mandate must require and Article 11(4) lists manufacturer obligations no mandate may hand over. Article 2(32) defines the representative as a person who "has received and accepted a written mandate from a manufacturer, located outside the Union" (MDR Art. 2(32)), which makes the document constitutive: without it there is no representative, and without a representative a non-EU manufacturer's device cannot lawfully be placed on the Union market.

Recital 35 states it in one line: "The tasks of an authorised representative should be defined in a written mandate." (MDR Recital 35) This post is about that document; for the role itself and the representative's standing duties, see our explainer on MDR Article 11. Because EU authorised representative mandates are read by regulators, not just by lawyers, precision in the mandate agreement pays for itself.

Designation, written acceptance and the sole representative rule

The formation rule is Article 11(2): "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)) Three consequences follow.

First, a designation letter issued unilaterally by the manufacturer is not yet a mandate: written acceptance is a validity condition, so a dated countersignature or separate acceptance must exist. Second, the mandate cannot be drafted narrower than a generic device group, which Article 2(7) defines as "a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics" (MDR Art. 2(7)). Third, because Article 11(1) requires a sole representative, a manufacturer may hold more than one mandate only where each covers a different generic device group.

Article 11(3) then sets the working rule and an inspection duty in two short sentences: "The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request." (MDR Art. 11(3)) That second sentence is the one manufacturers underestimate: this is a document a national authority can ask to read, so it must be signed, dated and consistent with EUDAMED, the label and the EU declaration of conformity.

The eight tasks an EU authorised representative mandate cannot exclude

The chapeau of Article 11(3) is a floor, not a menu: "The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers" (MDR Art. 11(3)). The construction is two-sided: the mandate must impose the task and the manufacturer must enable it, so a mandate listing tasks but giving no access to documentation fails the second half of the test.

Task in Article 11(3)	Can it be excluded from the mandate?	Practical note
(a) Verify that the declaration of conformity and technical documentation exist and, where applicable, that an appropriate conformity assessment procedure was carried out	No	An existence check, not an audit. Record how it was performed; an inspector will ask.
(b) Keep a copy of the technical documentation, the declaration of conformity and any certificate available to competent authorities for the Article 10(8) period	No	At least 10 years after the last device was placed on the market, 15 for implantables. Version control matters more than storage location.
(c) Comply with the registration obligations in Article 31 and verify that the manufacturer has complied with Articles 27 and 29	No	The representative registers itself and obtains its own SRN; the manufacturer's registration stays with the manufacturer.
(d) Provide competent authorities, on request, with the information needed to demonstrate conformity, in the official Union language the Member State determines	No	Drives the translation question: agree who produces and pays for translations, and by when.
(e) Forward competent authority requests for samples or device access, and verify the authority receives them	No	Verification is a separate duty from forwarding; sending an email and hearing nothing back is not compliance.
(f) Cooperate with competent authorities on preventive or corrective action on device risks	No	This pulls the representative into field safety corrective actions and recalls; name escalation contacts.
(g) Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents	No	Set a concrete forwarding route. The Regulation says immediately, so a 30-day contractual window contradicts it.
(h) Terminate the mandate if the manufacturer acts contrary to its obligations	No	A right of the representative. A mandate removing it, or subjecting it to manufacturer consent, is non-compliant.

What the mandate is not allowed to transfer

The counterpart to the minimum list is the prohibition in 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)) Those paragraphs cover design and manufacture, risk management, clinical evaluation, 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 action. None of it becomes the representative's legal responsibility, whatever the contract says.

MDCG 2022-16 draws the line usefully: "Whilst the manufacturer therefore can not delegate its responsibility for these tasks, the authorised representative is not prevented from assisting in the performance of those tasks." (MDCG 2022-16, section 4) Assistance is contractual; responsibility is statutory. Note which Article 10 paragraphs are absent from the Article 11(4) list, among them Article 10(13) on incident and field safety corrective action reporting and Article 10(14) on responding to competent authority requests. That absence is why vigilance support and authority correspondence are commonly written into an EU authorised representative mandate as delegated tasks.

Optional tasks you may add to the mandate

Beyond that floor the parties are free. MDCG 2022-16 confirms that "The manufacturer and the authorised representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed between the parties." (MDCG 2022-16, section 4) It also gives a pre-market example: "The manufacturer could for instance mandate the authorised representative to lodge, on its behalf, an application for conformity assessment according to annex IX, X, XI MDR/IVDR with a notified body at the pre-market stage." (MDCG 2022-16, section 4)

Commonly added tasks include acting as the contact point for vigilance correspondence, supporting device-side entries and Basic UDI-DI submissions once the manufacturer has registered, reviewing labels and instructions for use against Member State language requirements, and handling the EUDAMED SRN registration steps that fall on the representative's side. Write each as a defined deliverable with a turnaround time, because none is implied by Article 11(3) alone.

Scope, language and documentation access in the EU authorised representative mandate

Three drafting points cause most trouble. Scope first: list the generic device groups, device names and Basic UDI-DIs covered, and say whether legacy devices are included. MDCG 2022-16 is explicit that for legacy devices "this includes Article 11(3)(c)-(g) MDR/IVDR and the mandate between the manufacturer and the authorised representative should be updated accordingly." (MDCG 2022-16, section 12)

Language comes second. The Regulation sets no language for the mandate itself, so English is normal in practice, but Article 11(3)(d) requires documentation to reach an authority "in an official Union language determined by the Member State concerned" (MDR Art. 11(3)(d)). An authority asking for a copy of the mandate may reasonably want it in its own official language, so agree in advance who prepares translations and at whose cost.

Access to documentation comes third, and it is a manufacturer obligation rather than a representative one. The third subparagraph of Article 10(8) requires a manufacturer outside the Union to "ensure that the authorised representative has the necessary documentation permanently available" (MDR Art. 10(8)). MDCG 2022-16 reads permanent availability as constant access via electronic or physical storage, in the most recent versions. The mandate should therefore name the repository, the update trigger and the person who pushes revisions; otherwise the representative cannot meet Article 11(3)(b) and the manufacturer is in breach of Article 10(8).

Termination: the exit route the Regulation writes into every mandate

Article 11(3)(h) requires the mandate to let the representative "terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation." (MDR Art. 11(3)(h)) MDCG 2022-16 confirms this is a right of the representative. Commercial notice periods may sit alongside it, but they cannot condition or override it.

Where the representative terminates on that ground, Article 11(6) adds a notification duty. It "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)) Termination also follows the scope rule. Because the mandate is effective at least for a whole generic device group, MDCG 2022-16 states that "the termination of the mandate is only possible with respect to the whole generic device group and not a specific device within that group, unless the specific device is removed/withdrawn from the market and so is outside the scope of the effective mandate." (MDCG 2022-16, section 8)

Ordinary termination is different from the Article 12 handover, which requires a defined agreement between the manufacturer, the outgoing representative where practicable, and the incoming one, covering dates, document transfer and continuing complaint forwarding; that process is covered in our post on changing your authorised representative. The IVDR mirrors all of this, with the non-delegable set at Article 10(1) to (6) and (8) to (11).

Where Medex fits

Medex acts as an EU authorised representative under MDR and IVDR Article 11, registered in EUDAMED under SRN TR-AR-000057550, with an in-house person responsible for regulatory compliance and a deputy. We issue a mandate that meets the Article 11(3) minimum and names the further tasks we take on; we do not carry out notified body conformity assessment, we do not write clients' technical documentation and we do not find distributors, and annual fees by device class are published on our pricing page alongside the scope of the EU authorised representative service.