Your EU Authorised Representative carries legal liability. Choose one that reads your technical file.
Full-scope EU AR services under EU MDR 2017/745 and IVDR 2017/746 — EUDAMED registration, documentation custody, vigilance handling and competent-authority response, delivered by people who assess devices for a living.
If you are a manufacturer established outside the European Union and you place a device on the EU
market, EU MDR 2017/745 and IVDR 2017/746 require you to appoint an Authorised Representative established
in the Union. The mandate is not administrative. Your AR is jointly accountable for specific obligations,
is the party a competent authority contacts first, and in defined circumstances shares liability with you
for a defective device.
An AR mandate is easy to price as if nothing will happen. We work on the assumption that something will — because when a competent authority asks a technical question about your device, an AR who has never read your technical documentation cannot answer it, and the clock does not stop while they learn.
The mandate is a legal position in the supply chain, not a forwarding address. Once a device is placed on the EU market, a sponsor that imports or supplies it can occupy one of these boxes without having decided to.
What qointa does as your AR
Registration. Actor registration and device registration in EUDAMED, with the UDI-DI
structure checked against your product hierarchy before it is submitted rather than after.
Documentation custody. We hold a copy of the EU declaration of conformity, the
technical documentation and the certificates, and keep them available to authorities for the period the
regulation requires.
Verification, not filing. Before the mandate starts we verify that the declaration of
conformity has been drawn up, the conformity assessment route is correct for the class, and the
technical documentation is complete against Annex II and III. Gaps are reported to you as findings.
Vigilance and post-market. Receipt and forwarding of incident reports and field safety
corrective actions, sample and complaint handling, and support to your PMS and PSUR obligations.
Authority interface. We are the named point of contact and we respond in the language
and register the authority expects, with your technical input, not in place of it.
Mandate termination. A clean handover protocol if you change AR or establish your own
EU entity — including the notification duties most mandates leave undefined.
How AR onboarding works in practice
Appointing an AR is not a signature on a letter. Onboarding takes four steps:
Mandate and scope — which devices, which markets, which vigilance and
registration duties the AR accepts.
Technical file review — we read the file before we register anything, because
the competent authority will read it later.
EUDAMED and UDI — actor registration, device registration and hierarchy
checks before submission, not after a rejection.
Operating rhythm — incident reporting, FSCA coordination and documentation
updates with named owners on both sides.
Trials work differently. A device supplied only for a clinical investigation is not placed on the market, so importer and AR duties do not attach to it as such. Instead, a sponsor not established in the EU must have a legal representative established in the Union (EU MDR Art. 62(2), IVDR Art. 58(4)); some Member States accept a contact person instead for investigations run only on their territory. Importer and AR duties apply once the same device is also placed on the EU market. We assess this per device and per supply chain, rather than assuming it away because the study is temporary.
Verification comes before the signature. Everything after it is custody, vigilance and being reachable — until the mandate is handed over cleanly.
Where the AR mandate meets a clinical trial
The question we are asked most often is not about a marketed device. It is about a device deployed in a
trial: a wearable, a point-of-care analyser or a connected sensor, supplied by a non-EU vendor, where the sponsor’s role has shifted without anyone deciding it should — towards manufacturer of an investigational device, or, if the device is also placed on the EU market, importer or distributor. Perimeter six of our
assessment — the economic-operator role — exists precisely for this. A sponsor or CRO that ships a device
across a border, relabels it, or supplies it to a site under its own name may have taken on obligations it
has not budgeted for.
We assess that position before it becomes a finding, and we say plainly when an AR mandate is not the answer: an EU sponsor that becomes the manufacturer needs no AR, and a sponsor established outside the EU running an investigation needs a legal representative, not an AR.
The device crosses the border; the roles — and the obligations — attach one by one.
Who this is for
Non-EU medical device and IVD manufacturers entering or holding an EU position; digital health companies
whose software is a device in the EU even where it is not one at home; and sponsors or CROs who need to
know which economic-operator role they are actually occupying.
Choosing an AR that can read your technical file
We read your technical documentation before the mandate starts, so an authority’s first technical question does not start a learning curve. Whichever AR you appoint, check:
Whether they can explain your intended purpose in the authority's language.
Whether they maintain your technical documentation as a living set, not a
PDF archive.
Whether they have run vigilance and FSCA for software and connected devices,
not just hardware SKUs.
Whether they can connect the AR role to your clinical trial supply chain when
the same device is both investigated and placed on market.
Start with the paper that settles the role
The first is free and needs no account — it is the one that tells you whether you have already become an importer or a distributor. The two below it open with a free account.
