The regulatory framework for medical devices in Spain is facing an immediate and far-reaching operational change. The Spanish Agency for Medicines and Health Products (AEMPS) has announced the launch of RECOPS, the new centralised IT application for the registration of the placing on the market of medical devices (except for custom-made devices) and diagnostic medical devices in vitro.
This platform, which will be fully operational on the 15 June 2026, will enable the authorities to record and ascertain exactly which products are sold in Spain, whilst directly monitoring their instructions for use and labelling.
At M CAMPS, as a pharmaceutical consultancy with over 30 years’ experience, we analyse the impact of this measure and the critical deadlines that companies in the sector are required to meet.
Transition timetable and key dates to note down
The roll-out of RECOPS involves taking the previous systems offline and achieving full synchronisation with the European databases. The key deadlines set out in the official information note are:
- 27 May 2026: The requirement to use the old applications has come to an end CCPS y RPS.
- 28 May 2026 (Today): New registrations have been suspended in CCPS and RPS. Both systems are now in read-only mode. (Note: The RPS application will remain active solely for manufacturers of custom-made medical devices).
- 15 June 2026: Official launch of RECOPS.
- 17 June 2026: Celebration of a webinar an information session organised by the AEMPS to explain how the tool works.
How will RECOPS affect your business?
The new technical procedure complies with the provisions of Royal Decree 192/2023 and the recent Royal Decree 942/2025. From now on, any economic operator marketing these products within Spanish territory must comply with two essential requirements:
- Full Eudamed dependency: In order to register a product with RECOPS, this it must have been previously notified and be visible in the European Eudamed database, as the new Spanish app will retrieve the data directly from the European platform.
- 6-month period: The mandatory notification to RECOPS must be made within a period of not exceeding six months from the date of notification of the product on Eudamed.
The end of an era: What will happen to the CCPS and RPS data?
The introduction of RECOPS marks the definitive end of the IT platforms that have formed the backbone of the national register to date. It is essential that businesses understand that The CCPS and RPS systems do not disappear suddenly, but are put on hold. This means that they will continue to be accessible solely for the purpose of consulting the record history.
This historic change coincides with the requirement to link directly to the European Eudamed platform. The sector must recognise that it is no longer a matter of manually entering data into the AEMPS’s systems in isolation, but rather of managing an international, transparent and fully coordinated data synchronisation process between European regulatory bodies and the national authorities in Spain.
Recommendations from M CAMPS to prepare for the migration
To ensure that this change of platform does not disrupt the supply chain or hold up scheduled launches, our technical team recommends adopting a proactive strategy:
- Eudamed audit: Please check that all the products in your current catalogue have been correctly uploaded, validated and are visible in the European database. If a product does not appear in Eudamed, it will be technically impossible to register it in RECOPS from 15 June onwards.
- Technical labelling review: Please ensure that the instructions for use (IFU) and the digitised labelling match exactly the documentation that RECOPS will inherit from the European Union.
- Monitoring of import deadlines: Work closely with your quality and regulatory departments to ensure you comfortably meet the maximum six-month timeframe required by the AEMPS.
At M CAMPS, we’re here to support you through the transition to RECOPS
This change of platform is not merely a technical formality; it requires perfect prior synchronisation with European registers and a thorough review of the labelling and instructions for use that are to be submitted to the authorities. Any error or delay in reporting could temporarily bring commercial activity relating to the product in Spain to a standstill.
If you need technical support to register your products, manage your new profiles in the app or check that your documentation strictly complies with Royal Decree 192/2023 and Royal Decree 942/2025, the team at M CAMPS is entirely at your disposal.
👉 Get in touch with the expert team at M CAMPS to ensure the continuity of your business without any regulatory issues.
Official reference links:
- You can find all the technical details in the PS Information Note No. 24/2026 on the AEMPS website.