The Spanish Agency for Medicines and Medical Devices has reported the launch of RECOPS, the new application for the registration of the marketing of medical devices and in vitro diagnostic medical devices. This platform complies with the registration established in Article 18 of Royal Decree 192/2023, of 21 March, which regulates medical devices, and in Article 15 of Royal Decree 942/2025, of 21 October, which regulates in vitro diagnostic medical devices.
With the entry into force of RECOPS, communications through the old CCPS and RPS applications regulated by the previous Royal Decree 1591/2009, of 16 October, which regulates medical devices, will cease. From May 28th both platforms will remain available for consultation purposes only, coinciding with the start of the mandatory notification to Eudamed. However, manufacturers of custom medical devices will need to continue to use RPS for their communications.
RECOPS will be operational on June 15th, 2026. From that date, any economic agent that markets medical devices or in vitro diagnostic medical devices in the Spanish territory must register them on this platform within a maximum period of six months from their notification to Eudamed.
For more information, please contact our specialists through the Knowledge and Innovation Area.
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