AEMPS prior operating licence and EUDAMED registration as manufacturer or importer
...we take care of the management!
What is it and who does it apply to?
The AEMPS prior operating licence is the authorisation the agency grants to a company established in Spain before it starts to manufacture, import or group medical devices or in vitro diagnostic devices. It authorises the company and its facilities, not a specific device: it is the step before any medical device activity in Spain.
It is a separate procedure from EUDAMED registration, the European database where each economic operator obtains its single registration number (SRN) and where the manufacturer registers its devices with their unique identifier (UDI). The licence is national and concerns the company; EUDAMED is European and covers operators and devices. A Spanish company needs both.
It applies to manufacturers (including those who manufacture complete devices for third parties), importers and groupers. Distributors do not need a licence, but they have their own notification duties and must verify the devices they distribute.
What the regulation requires
In Spain the licence is governed by Royal Decree 192/2023 of 21 March on medical devices, and the procedure follows the AEMPS instruction PS1/2022, updated to reflect that Royal Decree's requirements for serial manufacturers, manufacturers for third parties, importers and groupers.
In Europe, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) require operators and devices to be registered in EUDAMED. Its first four modules are mandatory since 28 May 2026, and legacy devices with a directive certificate must be registered before 26 November 2026. Only the manufacturer may assign the UDI and register its devices.
In addition, since 15 June 2026 devices marketed in Spain must be registered in RECOPS, the AEMPS application that replaces the former CCPS and RPS systems.
What we do at MeDev Consulting
AEMPS Manufacturing / Import License Processing
We manage all the procedures!
Documentation
We manage and process all necessary information before the AEMPS.
Inspection
We help you pass the inspection successfully and with full confidence.
Resolution
We resolve any deviations detected during the process.
Registrations
Operator (SRN) and device (UDI/DI) registration in EUDAMED and RECOPS registration.
The prior operating license is a mandatory requirement for Spanish companies wishing to manufacture or import any medical device or IVD in the European Union. It is a complex procedure that must be approved by the AEMPS (Spanish Agency for Medicines and Medical Devices).
At MeDev Consulting we manage and process all necessary information, help you pass the inspection and resolve any deviations detected.
How we work
- 1
Preliminary review
We check facilities, organisation and quality system against AEMPS requirements and tell you what is missing before anything is filed.
- 2
Licence application
We prepare and file the application with all the documentation required by instruction PS1 and Royal Decree 192/2023.
- 3
AEMPS inspection
We accompany you during the inspection and resolve with you any deviations that may be found.
- 4
Registrations and upkeep
Operator (SRN) and device registration in EUDAMED, RECOPS registration and follow-up of the ongoing obligations.
Frequently asked questions
Who needs the AEMPS prior operating licence?
Any company established in Spain that manufactures, imports or groups medical devices or in vitro diagnostic devices, before starting the activity. Distributors do not need a licence but a prior notification to their regional health authority.
What does the AEMPS inspect before granting the licence?
The facilities, the quality system and the product documentation, as well as the appointment of a technical manager with the required qualifications. The inspection goes more smoothly if an internal review has been done beforehand using the same criteria.
I already have a licence: what if I move premises, change technical manager or add products?
Each of those changes must be notified to the AEMPS and, depending on the case, means amending the licence with a new inspection. It is best planned before moving the activity, not afterwards.
What is the SRN and who assigns it?
It is the single registration number that EUDAMED assigns to each economic operator (manufacturer, importer or authorised representative). It is requested in the actor module and validated by the competent authority, which in Spain is the AEMPS. Without an SRN no devices can be registered.
Since when is EUDAMED mandatory?
Since 28 May 2026 for the four modules declared functional (actors, UDI and devices, notified bodies and certificates, and market surveillance). Legacy devices with a directive certificate must be registered before 26 November 2026.
Can my notified body or my authorised representative register my devices in EUDAMED?
No. The manufacturer is solely responsible for assigning the UDI and registering its devices, even if another company sells them under its own brand. The authorised representative registers its own actor, not the manufacturer's devices.
What is RECOPS and how does it differ from EUDAMED?
RECOPS is the AEMPS application that replaces CCPS and RPS and registers the devices marketed in Spain together with their instructions and labelling; it is mandatory since 15 June 2026. EUDAMED is the European database. They are separate registers and both are mandatory.
Can a start-up without a finished product apply for the licence already?
It is best planned in parallel with development, because the licence requires operational facilities and quality system: it is not granted on paper. The usual moment to start is when the quality system is in place and the product enters its final phase.
Related news
New MDCG 2026-5
MDCG 2026-5 clarifies that only the manufacturer may assign the UDI and register the device in EUDAMED, even when sold under a distributor's brand.
EUDAMED 2.27.0 released, the version that becomes mandatory from 28 May 2026 for SRN and new devices – 28 Nov 2026 for all devices
EUDAMED 2.27.0 released, the version that becomes mandatory from 28 May 2026 for SRN and new devices – 28 Nov 2026 for all devices: we help you through the process …
AEMPS updates Instruction PS1/2022 to include the requirements established in Real Decreto 192/2023 (Royal Decree) of 21 March, regulating medical devices.
AEMPS updates instruction PS1/2022 with the requirements of Royal Decree 192/2023 for medical device manufacturers, importers and groupers.
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