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Importing medical devices into Spain requires compliance with two overlapping layers of regulation: EU-level rules under the Medical Device Regulation (EU) 2017/745 (MDR), and Spanish national administrative requirements enforced by the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios). Both must be in place before you import medical devices into Spain: an MDR-compliant CE mark is necessary but not sufficient — without the AEMPS import authorisation, the product cannot legally enter the Spanish market. The process is predictable once you understand the sequence and the timeline involved.
The AEMPS import licence: who needs it and how to obtain it
Unlike some EU Member States, Spain maintains a national import authorisation requirement for medical devices. Any company importing medical devices into Spain — whether as a distributor, importer, or the manufacturer’s local subsidiary — must hold a valid AEMPS import authorisation (autorización de importación de productos sanitarios) before placing the products on the Spanish market. This licence is issued by the AEMPS after verifying that the applicant has adequate infrastructure, a qualified responsible person (técnico responsable), and a quality management system — typically ISO 13485 certification.
The application is submitted through the AEMPS electronic platform and typically takes between three and six months to process. Required documentation includes the company’s details and legal registration, the ISO 13485 certificate and its scope, the responsible person’s academic qualifications and CV, and a product list with device classification. One common mistake is initiating the import process before the licence is granted: the AEMPS does not issue provisional authorisations, and goods already in transit cannot be cleared through customs without the licence being active. The application should be submitted at least six months before the expected first shipment.
EU Authorised Representative: the prerequisite for non-EU manufacturers
If the manufacturer of the medical devices is established outside the European Union, an EU Authorised Representative must be formally designated before any other compliance step can begin. Under Article 11 of the MDR, the Authorised Representative is jointly and severally liable with the manufacturer for the devices’ regulatory compliance. They must be registered in EUDAMED, and their name and address must appear on the device label alongside the manufacturer’s details — a labelling requirement that often surprises importers who discover it only when their shipment is held at customs.
We regularly work with companies that have been importing devices for years without a formalised Authorised Representative arrangement — or with an arrangement that was never registered in EUDAMED. This creates a significant compliance gap: the AEMPS can require the importer to withdraw the product from the market until the situation is regularised. For the full scope of what the Authorised Representative role involves and what the mandate must contain, see our article on EU Authorised Representative obligations under MDR.
EUDAMED registration: mandatory since May 2026
Since May 2026, registration in EUDAMED (the European Database on Medical Devices) is no longer optional for medical devices placed on the EU market. Both the device and the relevant economic operators — manufacturer, Authorised Representative, and importer — must be registered. For importers specifically, this means obtaining an SRN (Single Registration Number) and ensuring that each device is registered with its UDI-DI (Unique Device Identifier — Device Identifier).
The EUDAMED obligation applies regardless of whether the product holds a CE mark under MDR or is still operating under a legacy certificate from the old Medical Devices Directive (MDD). The transitional arrangements that allow MDD-certified devices to remain on the market do not extend the EUDAMED registration deadline. If you are importing devices under a transitional MDD certificate, EUDAMED registration is already required now.
Technical documentation: what the importer must verify
Article 13 of the MDR sets out the importer’s verification obligations before placing a device on the market. The importer must confirm that: the device bears the CE marking; the manufacturer has drawn up the EU Declaration of Conformity; the device carries compliant labelling in Spanish; and the device is registered in EUDAMED with a valid UDI. For class IIa, IIb, and III devices, the importer must also verify that the Notified Body certificate cited in the Declaration of Conformity is currently valid and covers the specific device model being imported.
A recurring issue: importers obtain a copy of the CE Declaration but do not verify that the Notified Body number corresponds to an active certificate. Certificates expire — and in some cases the Notified Body itself has lost its designation under MDR. An expired or withdrawn certificate means the CE Declaration is no longer valid, and the importer who placed the product on the market under that declaration is exposed. We covered the full documentation review in our article on technical documentation under MDR: what the importer must verify.
Labelling in Spanish: before customs, not after
Medical device labelling in Spain must comply with Article 10(11) of the MDR and include — in Spanish — the manufacturer’s name and address, the Authorised Representative’s details, the UDI carrier (barcode or RFID), the device name and model, applicable warnings or precautions, expiry or manufacture date where relevant, and a translation of any symbols that are not universally standardised. Devices that arrive with labelling only in the manufacturer’s language must have compliant Spanish labelling arranged before customs clearance — the AEMPS market surveillance unit can order a product withdrawal if non-compliant labelling reaches the end customer.
Frequently asked questions
Does every company importing medical devices into Spain need an AEMPS licence?
Yes. Any company placing medical devices on the Spanish market — regardless of whether it is a distributor, importer, or the manufacturer’s own subsidiary — must hold a valid AEMPS import authorisation. The licence is updated when the product portfolio changes significantly.
Can I start importing while my AEMPS licence application is being processed?
No. The AEMPS does not issue provisional authorisations. Goods imported without a valid licence are subject to customs retention and administrative sanctions. Submit the application at least six months before the first expected shipment.
If your company is planning to import medical devices into Spain and needs guidance on the AEMPS licence process, EUDAMED registration, or your obligations as an importer under the MDR, our regulatory team at ASC Services manages all stages of the authorisation process. Contact us through our contact page with your product type and expected timeline and we will map out the steps for you.