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If you import medical devices into the EU through Spain, registering as an economic operator in EUDAMED is not administrative paperwork you can leave until later. Under the Medical Devices Regulation (EU) 2017/745 (MDR), it is a legal precondition before any device you handle reaches the market, and it produces a Single Registration Number (SRN) that identifies you across the entire EU system. This guide covers what you submit, how the AEMPS validates it, what it costs, the mistakes that delay it, and why the SRN is not the same as the Spanish import licence.
Who has to register — and why the importer specifically
Under Article 13 of the MDR an importer is an EU-established economic operator that places a device from a third country on the EU market. Article 31 then requires manufacturers, authorised representatives and importers to register in EUDAMED’s actor module before the device is placed on the market.
The reason the importer is named explicitly is structural. When the manufacturer sits outside the Union, the importer is one of the first operators the regulation can hold accountable inside the EU — the entity an authority contacts, the name that keeps the supply chain traceable. Registration is per legal entity, not per device or per shipment: you register once as an operator, and that identity then attaches to everything you import.
What you actually submit: Annex VI, Part A
Registration runs through the electronic system for economic operators set up under Article 30. The information you provide is listed in Annex VI, Part A, and in practice it covers:
- the legal entity: name, registered trade name and full address;
- the type of economic operator (here, importer) and the range of devices concerned;
- the contact details of the person responsible;
- the identification of your Person Responsible for Regulatory Compliance (PRRC).
The data has to be consistent with your other records — company registry, tax identifier, the details the manufacturer holds about you. Inconsistencies here are the single most common reason a registration is bounced back for correction.
The SRN: one number for the whole EU
Once the competent authority verifies the data (Article 31(2)), the system issues and assigns you a Single Registration Number. In Spain, the authority that validates the actor registration is the AEMPS. From that point the SRN identifies you in every EUDAMED module, in your dealings with notified bodies, and along the supply chain. It is not a formality you file and forget: it becomes your regulatory identity in the system.
The PRRC: the role behind the registration
The MDR requires economic operators to have a Person Responsible for Regulatory Compliance — someone with the qualifications and authority to ensure conformity, oversee vigilance and keep documentation in order. For a small importer, the PRRC can be someone within the company or engaged externally, but the role is real: it is the person an authority expects to reach when there is a regulatory question. Naming a PRRC who does not actually perform the function is a weakness an inspection will find.
Step by step
- Create an EU Login account — the Commission’s authentication used across EUDAMED.
- In the actor registration module, submit the Annex VI Part A data for your legal entity and declare your role as importer.
- Identify your PRRC and record their details.
- Submit the request; the AEMPS reviews and validates it.
- On validation, the SRN is issued. Keep it: you quote it in every later EUDAMED action and along the supply chain.
How long it takes, and what it costs
The EUDAMED actor registration itself carries no fee, and the SRN does not expire. What determines the timeline is the quality of the data you submit and the AEMPS validation queue: a clean, consistent submission is validated far faster than one the authority has to send back. And the obligation is continuous — Article 31(4) requires you to update the data within one week of any change: a new address, a change of PRRC, a change of activity or legal entity. An SRN tied to outdated data is a finding waiting to happen.
The mistakes that delay an importer registration
- Registering the wrong legal entity — a trading name instead of the registered company, or the group parent instead of the entity that actually imports.
- No real PRRC — a name on the form with no one performing the function.
- Data that does not match the manufacturer’s records or the company registry.
- Treating it as a one-off — forgetting the one-week update duty when something changes.
- Confusing it with the Spanish licence and assuming one covers the other (see below).
EUDAMED registration is not the Spanish import licence
This is where importers most often get caught. The EUDAMED SRN is an EU-level identifier; it does not authorise your facility or your import activity in Spain. To import medical devices into Spanish territory you also need the national prior operating licence for importers, granted by the AEMPS under Real Decreto 192/2023 — a separate procedure we cover in our guide on importing medical devices into Spain. A company importing from outside the EU into Spain typically needs both: the SRN identifies the operator across the EU; the AEMPS licence authorises the activity nationally.
Where EUDAMED registration sits among your other obligations
The actor registration is the first EUDAMED step, not the last. It underpins device registration and UDI (Article 29), the vigilance and market surveillance modules, and, for the Spanish market, the AEMPS communication of commercialisation. Getting the actor registration right and keeping it current is what lets the rest of the system work; a wrong or stale SRN propagates errors into every module that references it. Your general duties as importer — verifying CE marking, the EU Declaration of Conformity, labelling and UDI — are set out in Article 13 and summarised in our guide to the importer’s obligations under the MDR.
Frequently asked questions
Is the EUDAMED SRN the same as my AEMPS import licence? No. The SRN (Article 31) is an EU-wide operator identifier; the AEMPS import licence (RD 192/2023) authorises your activity in Spain. You generally need both.
Do I need an SRN if the device already has a CE mark? Yes. CE marking is the manufacturer’s; importer registration and the SRN are your own obligations under Articles 13 and 31, independent of the device’s CE status.
One SRN per company or per device? Per legal entity. You register once as an operator; the SRN then attaches to the devices you import.
What happens if my details change? You must update EUDAMED within one week (Article 31(4)). An outdated registration is a compliance gap an inspection can act on.
How ASC Services helps
We set up and run your position as importer of record: we register you as an economic operator in EUDAMED, prepare the Annex VI data so it validates first time, obtain your SRN, support your PRRC, and coordinate the AEMPS national import licence so neither the EU nor the Spanish obligation is left half-done — with our Technical Manager validating and signing each regulatory output. Whether you import from Asia or the Americas, we make your position legally sound. Read our guide on the importer’s obligations under the MDR or talk to our team through our contact page.