New application for reporting medical devices: RECOPS
The Spanish Agency for Medicines and Medical Devices has launched RECOPS, the new Medical Devices Marketing Register. This application represents a significant change for economic operators marketing medical devices and in vitro diagnostic medical devices in Spain, as it centralises the national notification of these products and links it to the information available on EUDAMED.
What is RECOPS?
RECOPS is the AEMPS’s new IT application designed for the marketing registration of medical devices that are not custom-made, as well as in vitro diagnostic medical devices. Its purpose is to enable the health authority to identify which products are marketed in Spain, together with essential information such as their instructions for use and labelling.
When does it come into operation?
RECOPS comes into operation on 15 June 2026. From that date, economic operators marketing medical devices in Spain must submit their notifications via this new application within a maximum of six months from the date the product has been notified and is visible on EUDAMED.
What will happen to CCPS and RPS?
The old CCPS and RPS applications will generally cease to accept new notifications from 28 May 2026, coinciding with the start of mandatory notification to EUDAMED. However, RPS will continue to be used for notifications relating to manufacturers of custom-made medical devices.
Key points for economic operators
- RECOPS applies to medical devices and in vitro diagnostic medical devices placed on the market in Spain, with the exception of custom-made devices.
- The device must have been previously notified and be visible on EUDAMED.
- The notification to RECOPS must be made within a maximum of six months of the notification on EUDAMED.
- The application allows information on marketed products to be recorded, including instructions and labelling.
- Previous records are primarily for reference purposes, with the exception of the use of RPS for custom-made products.
Key aspects of registration with RECOPS
- It is essential that products are registered with EUDAMED in order to register them with RECOPS.
- From the date of registration of the products in EUDAMED (6 months from 28 May 2026), economic operators required to register products in RECOPS will have 6 months from the date of registration of the product in EUDAMED.
- Any applicable legacy products will be exempt from this RECOPS registration.
- Unlike the previous CCPS platform, RECOPS allows products to be linked to other economic operators, thereby avoiding duplication of information in the product register.
Why is this development important?
The launch of RECOPS strengthens control of the domestic market and improves the traceability of medical devices marketed in Spain. For companies, this means reviewing their internal procedures, ensuring correct notification in EUDAMED and adapting their regulatory workflows to comply with the new deadlines and reporting requirements.
Recommendations for preparation
- Check which products marketed in Spain fall within the scope of RECOPS.
- Verify that the product information has been correctly notified and is visible on EUDAMED.
- Review the instructions for use, labelling and identifying details before submitting the notification.
- Update internal regulatory procedures to incorporate the new six-month deadline.
- Train the teams responsible for regulatory affairs, quality and marketing on how to use the new application.
Conclusion
RECOPS marks a new era in the reporting of medical devices in Spain. Beyond being a new IT tool, it represents a step towards greater integration between national and European information, and requires economic operators to maintain a more organised, up-to-date and coordinated regulatory management system.