Can an EU authorised representative write my technical documentation?

No. Article 10(4) MDR requires the manufacturer to draw up and keep up to date the technical documentation, and Article 11(4) lists Article 10(4) among the obligations a mandate cannot delegate. An authorised representative may review the file, flag gaps and keep a copy at the disposal of competent authorities under Article 11(3)(b), but authorship and maintenance remain the manufacturer's responsibility at all times.

Can my authorised representative sign the EU declaration of conformity?

No. Article 10(6) MDR places the drawing up of the EU declaration of conformity on the manufacturer, and Article 11(4) makes Article 10(6) non-delegable. Article 19(3) reinforces this: by drawing up the declaration, the manufacturer assumes responsibility for compliance. The authorised representative's duty under Article 11(3)(a) is to verify that the declaration has been drawn up, not to draw it up.

Does MDR Article 11(4) list every obligation the manufacturer keeps?

No. Article 11(4) names Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). The paragraphs it omits, such as 10(8) on retention and 10(14) on responding to authorities, are not transferable either; the authorised representative simply has parallel duties under Article 11(3)(b) and (d) that run alongside the manufacturer's own obligations rather than replacing them.

Can an authorised representative act as the manufacturer's PRRC?

No. Article 15(1) MDR requires the manufacturer to have a person responsible for regulatory compliance available within its own organisation, while Article 15(6) requires the authorised representative to have one at its disposal. MDCG 2022-16 confirms, citing MDCG 2019-7, that the PRRC for an authorised representative and for a manufacturer established outside the EU cannot be the same person.

Is my EU authorised representative automatically my importer?

No. Article 2(33) MDR defines an importer by what it does: placing a device from a third country on the Union market. A representative that never takes title to or ships the goods is not an importer, and the mandate does not create one. Where a single company performs both functions it must register in both capacities and meet both sets of obligations.

Does appointing an authorised representative reduce the manufacturer's liability?

No. Article 10(16) MDR still requires the manufacturer to hold financial coverage proportionate to risk class, device type and enterprise size. Article 11(5) adds the authorised representative as jointly and severally liable for defective devices where the manufacturer has failed to comply with Article 10. The mandate therefore expands the pool of liable parties rather than shrinking the manufacturer's exposure.

Can an authorised representative apply to a notified body on my behalf?

It can lodge the application if the mandate says so. MDCG 2022-16 gives lodging an Annex IX, X or XI application with a notified body as an example of an agreed task beyond the Article 11(3) minimum. What cannot be transferred is the substance: preparing the technical documentation, operating the quality management system and undergoing the assessment all remain with the manufacturer.

What an EU Authorised Representative Cannot Do Under MDR Article 11(4)

7 days ago

7 min read

An EU authorised representative cannot perform the manufacturer's core compliance work: conformity assessment, the technical documentation, the quality management system, risk management, clinical evaluation, the EU declaration of conformity, CE marking, the post-market surveillance system and corrective-action decisions all stay legally with the manufacturer. That is the whole of what an EU authorised representative cannot do, and it is not a matter of negotiation — MDR 2017/745 blocks the transfer of those obligations no matter what the mandate says.

Article 11(3) lists the tasks a mandate must give the authorised representative. Article 11(4) draws the boundary in the very next sentence, by naming the manufacturer obligations a mandate may not delegate. The two are read together: everything on the Article 11(4) list remains the manufacturer's responsibility even where the authorised representative helps prepare it.

MDR Article 11(4): the exact wording of the limit

The provision is one sentence long and admits no exceptions:

"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))

Ten paragraphs of Article 10 are ring-fenced. It is worth noticing what is absent: Article 10(5) on custom-made device documentation, 10(8) on record retention, 10(13) on the incident-reporting system, 10(14) on responding to competent authorities, 10(15) on identifying a contract manufacturer and 10(16) on liability and financial coverage. Their absence does not mean the manufacturer can hand them over. It means Article 11(4) does not need to address them, because Article 11(3)(b) and 11(3)(d) already give the authorised representative parallel duties that sit alongside — not instead of — the manufacturer's obligations under 10(8) and 10(14).

MDCG 2022-16, the Commission-published guidance on authorised representatives, states the practical consequence plainly: "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 permitted. Substitution is not. If you want the positive side of the role — the eight tasks that must be in every mandate — that is covered in detail in our explainer on MDR Article 11 and the authorised representative mandate.

The ten non-delegable obligations, one by one

Article 10(1) — devices are designed and manufactured in accordance with the Regulation. This is the root obligation; nobody outside the manufacturer's organisation can discharge it.
Article 10(2) — "Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I." (MDR Art. 10(2))
Article 10(3) — "Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF." (MDR Art. 10(3))
Article 10(4) — "Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices." (MDR Art. 10(4)) The authorship of the Annex II and III technical documentation is the manufacturer's, permanently.
Article 10(6) — the EU declaration of conformity and the CE marking.
Article 10(7) — UDI system obligations and the Article 29 device registration. MDCG 2022-16 is explicit: "It is noted that in line with Article 11(4) of the Regulations, the manufacturer’s obligation to register its information and devices in EUDAMED cannot be delegated to the authorised representative." (MDCG 2022-16, section 5(b))
Article 10(9) — conformity of series production and the quality management system, including the thirteen elements the Regulation requires that system to address.
Article 10(10) — "Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83." (MDR Art. 10(10))
Article 10(11) — the information accompanying the device, in the official Union language or languages the Member State determines.
Article 10(12) — the decision to bring a non-conforming device into conformity, to withdraw it or to recall it, and the duty to inform authorities where the device presents a serious risk.

What an EU authorised representative cannot do, mapped against who must

The clearest way to see the boundary is to put each activity next to the party the Regulation names. Note that the answer is sometimes neither the manufacturer nor the authorised representative.

Obligation or activity	Who must do it	Legal basis
Assess the conformity of the device before placing it on the market	Manufacturer	MDR Art. 52(1); Art. 10(1)
Assess the technical documentation and issue the certificate	Notified body	MDR Art. 52; Art. 56; Annexes IX to XI
Draw up and maintain the technical documentation	Manufacturer	MDR Art. 10(4); Annexes II and III
Operate the quality management system	Manufacturer	MDR Art. 10(9)
Run the risk management system	Manufacturer	MDR Art. 10(2); Annex I Section 3
Conduct the clinical evaluation and PMCF	Manufacturer	MDR Art. 10(3); Art. 61; Annex XIV
Draw up the EU declaration of conformity and affix the CE marking	Manufacturer	MDR Art. 10(6); Arts 19 and 20
Implement the post-market surveillance system	Manufacturer	MDR Art. 10(10); Art. 83
Decide on corrective action, withdrawal or recall	Manufacturer	MDR Art. 10(12)
Assign UDIs and register the devices in EUDAMED	Manufacturer	MDR Art. 10(7); Arts 27 and 29
Register the authorised representative's own details in EUDAMED	Authorised representative	MDR Art. 11(3)(c); Art. 31
Verify that the declaration, documentation and conformity assessment exist	Authorised representative	MDR Art. 11(3)(a)
Keep a copy of the documentation at the disposal of competent authorities	Authorised representative	MDR Art. 11(3)(b); Art. 10(8)
Cooperate with competent authorities on preventive or corrective action	Both, in their own roles	MDR Art. 11(3)(f); Art. 10(14)

Read the middle column carefully. The authorised representative's verbs are verify, keep, register, forward, inform and cooperate. The manufacturer's verbs are design, establish, conduct, draw up, implement and decide. That difference is the whole of the Article 11(4) boundary.

An authorised representative is not a notified body

The first entry on any honest list of what an EU authorised representative cannot do is issue a certificate, and this is the most damaging confusion in practice. A notified body is defined in the Regulation as a conformity assessment body designated in accordance with it — designated by a Member State authority, audited, and legally independent of the manufacturer. An authorised representative is appointed by the manufacturer under a private mandate. The two roles cannot merge: "Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI." (MDR Art. 52(1)) Where the device's class requires notified body involvement, only a designated body may issue the certificate. Our guide to the notified body route under MDR sets out which classes need one.

There is one nuance MDCG 2022-16 permits. A mandate may contain agreed tasks beyond the Article 11(3) minimum, and the guidance gives lodging an Annex IX, X or XI application with a notified body on the manufacturer's behalf as an example. Lodging the file is administrative. Producing the file, and being assessed against it, is not delegable.

Not an importer by default, and not a commercial agent

An importer is any natural or legal person established within the Union that places a device from a third country on the Union market. That is an activity test, not a title conferred by a mandate. An authorised representative that never takes title to goods, never ships them and never places them on the market is not an importer, and appointing one does not give a manufacturer an EU importer. Conversely, a company that does both must register in both capacities and meet both sets of obligations.

Equally, nothing in Article 11 makes the authorised representative a sales channel. The Regulation gives it no commercial function: no duty to find distributors, no authority to negotiate prices, no role in marketing. Another item on the list of what EU authorised representatives cannot do is act as your route to market. Distributor selection is a commercial decision that sits entirely outside MDR economic-operator law.

Not your PRRC, and not a second legal manufacturer

Article 15(1) requires the manufacturer to have a person responsible for regulatory compliance available within its own organisation. Article 15(6) separately requires the authorised representative to have one permanently and continuously at its disposal. These are two different people with two different employers, and MDCG 2022-16, citing MDCG 2019-7, confirms it: the guidance "highlights that the PRRC for an authorised representative and for an 'outside EU' manufacturer cannot be the same person." (MDCG 2022-16, section 10) The detail of the role is covered in our article on the person responsible for regulatory compliance.

Nor does an authorised representative become the legal manufacturer. Under Article 16, an economic operator assumes manufacturer obligations only if it markets a device under its own name or trade mark, changes the intended purpose, or modifies the device. Acting as authorised representative does none of those things. The name on the label, the declaration and the certificate remains the manufacturer's.

Not a way around Article 10(16) liability

Appointing an authorised representative adds a liable party; it does not remove one. The manufacturer's own duty survives intact: "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)) Article 11(5) then makes the authorised representative jointly and severally liable for defective devices where the manufacturer has not complied with Article 10 — an addition to the manufacturer's exposure, never a substitution for it.

MDCG 2022-16 puts the two provisions together explicitly, noting that whilst the manufacturer cannot delegate its obligations referred to in Article 11(4), the authorised representative may nonetheless remain legally liable for defective devices if the manufacturer has not complied with its obligations under Article 10. Understanding what an EU authorised representative cannot do therefore matters commercially as well as legally: a manufacturer that treats the mandate as an outsourcing of responsibility is exposed on both sides.

Where Medex fits

Medex acts as EU authorised representative under EUDAMED SRN TR-AR-000057550, performing the Article 11(3) tasks, holding the documentation at the disposal of competent authorities and handling EUDAMED registration for the representative role. We do not perform notified-body conformity assessment, we do not write clients' technical documentation, and we do not find local distributors — those sit with your notified body, your own regulatory team and your commercial organisation respectively.