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Under the EU Medical Devices Regulation (Regulation (EU) 2017/745, "MDR"), a manufacturer that is not established in an EU Member State cannot place a device on the EU market at all until it has designated a single authorised representative established within the Union. That obligation, and everything the authorised representative (AR) is legally required to do once appointed, sits in Article 11 MDR. This guide works through what Article 11 actually requires: what has to be in the written mandate, the minimum tasks the AR cannot delegate away, how the AR’s liability works, its role in vigilance reporting, and how a manufacturer changes AR without leaving a compliance gap.
Who needs an EU authorised representative, and why the role exists
Article 11(1) is unconditional for any manufacturer without an establishment in a Member State: before placing a device on the EU market, it must designate an authorised representative, and the designation applies to that manufacturer’s devices, not per-market. The AR is not an importer and it is not a distributor — MDR keeps these as three distinct economic-operator roles with separate obligations under Articles 11, 13 and 14, and conflating them is one of the more common compliance mistakes non-EU manufacturers make when they first read the regulation.
| Role | Who it typically is | Core obligation |
|---|---|---|
| Authorised representative (Art. 11) | An EU-established legal entity mandated by the manufacturer | Acts on the manufacturer’s behalf toward EU competent authorities; verifies conformity documentation exists; is the manufacturer’s registered contact point |
| Importer (Art. 13) | The EU-established entity that places a non-EU manufacturer’s device on the EU market | Verifies CE marking, EU DoC, UDI and AR designation are all in place before distributing; handles storage/transport conditions |
| Distributor (Art. 14) | Any other supply-chain entity making the device available | Verifies labelling, UDI and expiry are intact; does not verify the underlying technical file |
One EU-based company can hold more than one of these roles for the same device, but the roles are legally distinct even when the same organisation performs them.
What has to be in the mandate agreement
Article 11(2) sets the baseline for the mandate itself: it must be validated by the manufacturer, and it is only valid once the authorised representative has accepted it in writing. The mandate has to cover, at minimum, all devices of the same generic device group — a manufacturer cannot mandate an AR for one product line while leaving another uncovered and still place both on the market. In practice, the written mandate is the document a notified body or competent authority will ask to see first when checking that an AR relationship is real rather than nominal, so it needs to name the specific devices or device group in scope, the effective date, and explicitly assign each of the Article 11(3) tasks below to the AR.
The authorised representative’s minimum tasks (Article 11(3))
Article 11(3) does not let the mandate water down what the AR does — it sets a floor of tasks the AR must be empowered and obliged to perform for every device it is mandated on:
- Verify the paperwork exists. Confirm the EU declaration of conformity and the technical documentation have actually been drawn up, and, where a notified body is involved, that the appropriate conformity assessment procedure was carried out.
- Keep documentation available. Hold a copy of the technical documentation, the EU declaration of conformity and, where applicable, the relevant certificate, available for competent authorities to inspect.
- Respond to competent authority requests. Supply a competent authority with everything it needs to demonstrate a device’s conformity, on request.
- Pass on safety information. Forward to the manufacturer any complaints and suspected-incident reports it receives from healthcare professionals, patients or users.
- Terminate the mandate if the manufacturer stops complying. The AR must end the relationship if the manufacturer acts contrary to its MDR obligations — this is a duty, not just an option.
- Cooperate on corrective and preventive action. Work with competent authorities on any action taken to eliminate or mitigate risks a device poses, including field safety corrective actions.
These are minimums the mandate agreement itself must assign to the AR — a mandate that omits one of them, or that tries to make a task optional, does not satisfy Article 11(3).
Technical documentation access and how long it has to stay available
The AR’s document-access duty under Article 11(3)(b) is tied directly to the retention period the manufacturer itself is under: Article 10 requires the technical documentation, EU declaration of conformity and related certificates to stay available to competent authorities for at least 10 years after the last device covered by that declaration was placed on the market, extended to at least 15 years for implantable devices. The AR does not need to physically hold every document for that whole window, but it has to be able to actually produce them, or get them from the manufacturer fast enough to answer a competent authority’s request — a mandate that only promises documentation “on best efforts” does not meet the standard a market-surveillance inspection will test against.
Joint and several liability
Article 11 makes the AR’s exposure real, not just administrative. Where the manufacturer has not met its Article 10 obligations, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. This is the clause that makes AR selection a genuine risk decision for a non-EU manufacturer, not a box-ticking formality: an AR that accepted a mandate without actually verifying the technical file existed, and later turns out to have been fronting for a manufacturer with no real conformity documentation, can be pursued for the same liability the manufacturer faces. It is also why the Article 11(3)(a) verification duty is not cosmetic — a diligent AR checks the file exists before accepting the mandate, precisely because its own liability depends on the manufacturer’s compliance.
Vigilance duties: the AR’s role once a device is on the market
Article 11(3) obliges the AR to cooperate with competent authorities on corrective and preventive action, and that cooperation plays out through the MDR vigilance system in Articles 87–91: serious-incident reporting (Article 87), trend reporting (Article 88), and analysis of serious incidents and field safety corrective actions (FSCAs, Article 89). A field safety notice or FSCA reaching a competent authority always has to reach, at minimum, the competent authority of the Member State where the manufacturer or its authorised representative has its registered place of business — the AR’s registered address is one of the fixed addressees regulators use to route vigilance communication, which is exactly why the mandate needs a real, checkable EU establishment behind it rather than a mailbox.
SRN registration in EUDAMED
Before a device reaches the EU market, both the manufacturer and its authorised representative have to be registered as economic operators under Article 31 and hold a Single Registration Number (SRN) in EUDAMED’s Actor module — one of the modules that became mandatory on 28 May 2026. The AR’s SRN is what ties its Article 11 mandate to a specific, verifiable EU legal entity inside the regulatory system, and it has to be in place before that entity can act as AR for a device going to market. See CASRAI’s EUDAMED guide for the current module-by-module status and the registration sequence in full.
Changing authorised representative
Article 12 governs what happens when a manufacturer moves from one AR to another (or an AR withdraws). The outgoing AR, the incoming AR and the manufacturer have to agree a detailed change-of-representative arrangement covering, at minimum, the date the new AR takes over, the date the old AR’s designation ends, which documents transfer and when, and the manufacturer’s obligation to inform the relevant notified body of the change. Because the AR is a named, registered contact point for a live product on the market, a change that isn’t formally documented and communicated can leave a device with no valid AR of record for a period — which is itself a compliance failure, independent of anything else about the device.
Frequently asked questions
Can one authorised representative act for more than one manufacturer?
Yes. Nothing in Article 11 limits an AR to a single manufacturer — commercial AR service providers routinely hold mandates for many manufacturers at once. What Article 11(2) does require is that each mandate cover, at minimum, all of that manufacturer’s devices within the same generic device group.
Does the authorised representative have to be a device expert?
MDR doesn’t set a technical-qualification bar for the AR itself the way it does for a manufacturer’s person responsible for regulatory compliance (Article 15). What Article 11(3) actually demands is verification and documentation-handling competence — the AR has to be able to check the technical file and EU DoC exist and respond credibly to a competent authority, which in practice means AR organisations build real regulatory expertise even though the article doesn’t mandate a specific qualification.
What happens if the manufacturer and the authorised representative disagree about compliance?
Article 11(3) makes termination on those grounds a duty of the AR, not a discretionary option: if the manufacturer is acting contrary to its MDR obligations, the AR must end the mandate, and Article 11(5) requires it to immediately notify its own competent authority (and the relevant notified body, if one is involved) that it has done so and why.
Is a UK-based representative acceptable as the EU authorised representative?
No. Article 11 requires the authorised representative to be established in a Member State of the EU. Since the UK is not an EU Member State, a UK entity cannot serve as the MDR Article 11 authorised representative; manufacturers selling into both markets need a separate UK Responsible Person arrangement under the UK’s own medical device framework.
This guide covers the legal role and obligations set out in MDR Article 11; it is not a directory of authorised-representative service providers and does not recommend any specific organisation. Fact-checking status: needs review.
