The Spanish Agency for Medicines and Healthcare Products has recently announced the launch of the new app RECOPS for the marketing authorisation of medical devices.
The new platform RECOPS, which came into operation on 15 June and will run alongside the notification to the European portal Eudamed, put an end to notifications via the old apps CCPS y RPS.
RECOPS– The new app RECOPS (Register of the Marketing of Medical Devices), came into operation on 15 June, and is intended, according to the AEMPS website, for the «registration of economic operators marketing medical devices in Spain that are not custom-made, as well as in vitro diagnostic medical devices».
With the new application for the registration of medical devices, the AEMPS complies with the following national regulations:
- Royal Decree 192/2023 of 21 March, regulating medical devices – Article 18.
- Royal Decree 942/2025 of 21 October, regulating in vitro diagnostic medical devices – Article 15.
However, it is important to remember that reporting to the Medical Devices database remains mandatory Eudamed in the EU. In fact, for a manufacturer of medical devices to register its products with RECOPS, it is a prerequisite that they are already registered with Eudamed. A maximum time limit is even set for medical device companies to register with RECOPS its products: 6 months from the time of notification to the portal Eudamed.
With RECOPS now operational, notifications via the portals of CCPS y RPS, which were based on the previous regulations (Royal Decree 1591/2009 of 16 October, regulating medical devices). Although there is one exception: the manufacturers of bespoke medical devices they should continue to use RPS for their communications.
What is the new RECOPS (Register of the Marketing of Medical Devices) app used for?
The platform RECOPS, launched by the AEMPS to comply with the new national regulations on medical devices and in vitro diagnostic medical devices, will essentially enable the collection and retrieval of relevant information on:
- products sold
- regulatory data
- related documentation
- identification details required to ensure regulatory compliance
In short, this new digital tool will enable the Spanish medical devices sector to have more efficient and transparent control systems. And, in this way, it will bring the sector into line with the wider European regulatory framework.
It can therefore be said that the new RECOPS app will enhance safety in the medical devices sector, as it will provide national health authorities and consumers with more information about these products.
In this regard, it is worth noting this notice, which appears on the website set up by the AEMPS for the new app for the registration of medical devices:
"Information on medical devices and in vitro diagnostic medical devices marketed in Spain is available on CINAPS".
How does RECOPS affect manufacturers of medical devices?
In short, the launch of RECOPS This should not pose any major challenges for manufacturers of medical devices. Manufacturers will need to have more information available about their products, but that information should already be available when they register their products in the European medical devices database, Eudamed.
That said, companies will need to familiarise themselves with this new tool for registering medical devices for marketing and receive training on how to use it correctly. Alternatively, they can seek the assistance of an external partner, such as Gabinete Técnico Farmacéutico M. Camps, who is an expert in the regulation of medical devices, can handle these commercial communications with the AEMPS and help you make the transition to this new marketing authorisation format.