As announced in the AEMPS Information Note of May 2026, the new RECOPS platform (Registro de Comercialización de Productos Sanitarios) has been operational in Spain since 15 June 2026, replacing the previous CCPS and RPS portals. The former systems remain available solely for historical consultation, with the only exception of the RPS portal, which will continue to be used exclusively for the reporting obligations applicable to manufacturers of custom-made Medical Devices.
The obligation applies to economic operators placing Medical Devices on the Spanish market, in accordance with the applicable national legislation.
The main operational changes and requirements are outlined below:
- User registration: access to the RECOPS platform requires the creation of a new user account for each operator, regardless of whether active credentials were already available for the CCPS and RPS portals.
- EUDAMED requirement and documentation: to register a product in RECOPS, all products, both newly registered products and those previously registered through the former portals, must first be notified and visible in EUDAMED, as product identification data will be retrieved from the European database. During the registration process, it is mandatory to upload the instructions for use (IFU) and labels in Spanish.
- Migration of existing registrations: for all operators that have previously managed registrations through the CCPS and RPS portals, it should be noted that the transfer of existing registrations will not take place automatically but must be performed manually. In this case as well, the product must already be available in EUDAMED. The initial registration fee will not apply only in cases where there is full continuity and identity between the devices registered in the previous portal and those available in EUDAMED.
- Fees: product registration is subject to the applicable AEMPS fees. In addition to the registration fee for each UDI-DI code, an annual register maintenance fee is foreseen; however, further operational clarifications from the Authority are still awaited regarding the timing and implementation modalities.
>>> Thema supports manufacturers in accessing and maintaining the Spanish market by providing comprehensive assistance with the management of manual migration of registrations, EUDAMED notification and compliance with the new RECOPS procedures required by AEMPS. Contact us for a personalised consultation.
Sources:
