Medical device importer: everything you need to place a device on the Spanish market
...from the foreign supplier to the Spanish market, with guarantees
What is it and who does it apply to?
Under the MDR, an importer is whoever places on the European Union market a medical device manufactured outside it: bringing product from China, the United States, the United Kingdom, Turkey or any third country and placing it on the EU market for the first time. A distributor, on the other hand, buys product that is already inside the EU; its obligations are lighter.
It applies to companies that want to import and sell in Spain a medical device or in vitro diagnostic device already certified by its manufacturer: distributors importing directly, pharmacies and clinics buying abroad, and companies starting from scratch. One important warning: if you buy a finished device to sell it under your own brand, you stop being an importer and become the legal manufacturer, with all its obligations.
At MeDev Consulting we make you an importer with guarantees: we verify the manufacturer and the device before you buy, we handle the AEMPS licence and we do the registrations. Fixed, fast quotes: you will know what is needed and what it costs before starting.
What the regulation requires
Article 13 of Regulation (EU) 2017/745 sets the importer's obligations: before placing the device on the market it must verify that it bears the CE marking, that the EU declaration of conformity exists, that the manufacturer is identified and has an authorised representative in the EU, that labelling and instructions comply and are in the required language, and that the device carries its UDI. It must also appear as importer on the device or its documentation, register in EUDAMED, keep the declaration of conformity and cooperate with the manufacturer and the authorities in surveillance and recalls.
In Spain two requirements are added: the prior operating licence as importer granted by the AEMPS under Royal Decree 192/2023, with inspection of the facilities, and registration in RECOPS of the devices marketed, mandatory since 15 June 2026.
Importing without these steps exposes the importer to product immobilisation and penalties: the AEMPS inspects and Customs may hold goods without a licence.
What the manufacturer must meet before you buy
- Valid CE certificateIssued by a notified body where the class requires it; we check that the body exists and the certificate is in force.
- EU declaration of conformitySigned by the manufacturer for that device and version, with the MDR and applied standards referenced.
- Technical documentation availableThe manufacturer must be able to provide it to the authority; you must know it exists and how to obtain it.
- Authorised representative in the EUMandatory for every non-EU manufacturer; its name and address must appear on the label.
- Compliant labelling and instructionsSymbols, CE marking, batch, date, manufacturer and instructions in Spanish for the Spanish market.
- UDI assignedThe unique device identifier, on the label and registered by the manufacturer.
- Manufacturer registered in EUDAMEDWith its single registration number (SRN) and its authorised representative.
- Device registered in EUDAMEDWith its Basic UDI-DI; without device registration there is no legal marketing.
Look up your manufacturer, its authorised representative and your device in our EUDAMED search by name, SRN or UDI-DI. If they are not there, ask before you buy.
What we do at MeDev Consulting
Importer market-entry package
Manufacturer and device verification
Before you buy: documentary conformity report on the eight checklist items, EUDAMED search included. If the manufacturer does not comply, we tell you.
AEMPS importer licence
Complete application, support during the inspection and resolution of any deviations found.
Registrations and obligations
Operator registration (SRN) in EUDAMED, RECOPS registration, importer labelling and a surveillance and complaints procedure.
Fixed, fast quotes, sized to your project: you will know what it costs before starting.
How we work
- 1
Manufacturer review
We request and review the foreign manufacturer's documentation and check its EUDAMED registrations.
- 2
AEMPS licence
We prepare your importer licence application, accompany you during the inspection and close any deviations.
- 3
Registrations
Operator registration in EUDAMED (SRN) and device registration in RECOPS; labelling with your importer details.
- 4
Placing on the market
First import with the documentation in order and the surveillance procedure in place.
Frequently asked questions
I want to import a medical device from China: what do I need?
The manufacturer must hold a valid CE marking, an EU declaration of conformity, an authorised representative in the EU and an EUDAMED registration; and you need an AEMPS importer licence, a registration number (SRN) in EUDAMED and the device registered in RECOPS. The first thing we do is verify the manufacturer: if it does not comply, there is no project worth pursuing.
Can I import a device without CE marking and certify it myself?
Yes, but then you stop being an importer and become the legal manufacturer, with all its obligations: technical file, quality system and, depending on the class, a notified body. It is a different project and a different quote, and we will tell you so from day one.
What is the difference between an importer and a distributor?
The importer is the first to place the device on the European Union market from a third country; the distributor buys it once it is already inside the EU. The importer's obligations are heavier: AEMPS licence, EUDAMED registration and appearing on the device labelling.
Do I need an AEMPS licence to import?
Yes. The prior operating licence as importer, which the AEMPS grants after inspecting your facilities and organisation. Without it you cannot import or market medical devices in Spain.
How do I check that the manufacturer is really registered in EUDAMED?
By looking it up. In our EUDAMED search you can check manufacturers, authorised representatives and devices for free by name, registration number (SRN) or UDI-DI. If your manufacturer or device is not there, ask before you buy.
Does my name have to appear on the label?
Yes. The importer must appear on the device, on its packaging or in a document accompanying it, with its name and address, without covering or altering the manufacturer's or authorised representative's information.
How much does it cost to become an importer?
It depends on the number of devices, their risk class and the state of the manufacturer's documentation. We work with fixed, fast quotes: after a first no-obligation review we tell you what is needed and how much it costs, before starting.
What happens if the device causes problems once on the market?
The importer shares surveillance obligations: recording complaints, informing the manufacturer and the AEMPS of incidents and cooperating in corrective actions or recalls. We set the procedure up from the start so you know what to do.
Related news
RECOPS live since 28/05/2026 and mandatory since 15/06/2026
RECOPS, the Spanish application replacing CCPS and RPS, is mandatory since 15 June 2026 to register medical devices marketed in Spain.
Before 26 November 2026 → It will be mandatory to have your devices registered in EUDAMED, both for manufacturers and for importers of medical devices under the MDD
By 26 November 2026 legacy devices under the MDD must be registered in EUDAMED: the duty lies with the manufacturer, not the NB or the EC REP.
28 May 2026 → EUDAMED becomes mandatory for medical device manufacturers
Manufacturers must focus on completing the ACT and UDI/DEV modules, which are their direct responsibility: There is no more time to lose.