RECOPS: What is the new AEMPS Registration System and how will it affect your business?

The new Medical Devices Commercialisation Register (RECOPS) will become operational on 15 June, replacing the CCPS and RPS systems.

Digitalisation continues to transform the European healthcare sector. In this context, the Spanish Agency of Medicines and Medical Devices (AEMPS) has launched RECOPS, a new platform designed to centralise the registration of medical devices and in vitro diagnostic medical devices marketed in Spain.

This initiative represents another step towards European regulatory harmonisation, enhanced traceability and the simplification of administrative processes for economic operators active within the sector.

What is RECOPS?

RECOPS (Medical Devices Commercialisation Register) is the new application developed by AEMPS to manage communications related to the placing of medical devices on the Spanish market.

The platform will enable the collection and consultation of relevant information on marketed products, including regulatory data, supporting documentation and identification elements required to ensure compliance with applicable regulations.

Its objective is to facilitate market surveillance, improve transparency and advance greater integration with European medical device management systems.

👉 Official information regarding RECOPS can be found on the AEMPS website:
https://www.aemps.gob.es/informa/puesta-en-marcha-de-recops-la-nueva-aplicacion-para-el-registro-de-comercializacion-de-productos-sanitarios/

When will RECOPS come into force?

The new platform will become operational on 15 June 2026.

From that date onwards, all new communications related to the commercialisation of medical devices must be submitted through RECOPS, progressively replacing the systems currently in use.

The implementation of this new register forms part of Spain’s adaptation to the requirements established by the European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Which economic operators will be affected by this new AEMPS register?

At present, AEMPS has not yet specified which economic operators involved in the commercialisation of medical devices in Spain will be required to register through RECOPS. Nevertheless, the proper management of these registrations will be essential to ensure regulatory compliance.

Why is RECOPS important?

The creation of RECOPS responds to the need for more efficient, transparent and harmonised systems aligned with the European regulatory framework.

Its main benefits include:

Enhanced Traceability

It facilitates the monitoring of medical devices throughout the entire supply chain, strengthening the supervisory capabilities of the competent authorities.

Process Digitalisation

It reduces reliance on fragmented procedures and enables more efficient management of regulatory information.

Greater Transparency

It provides easier access to up-to-date information on medical devices marketed in Spain.

Alignment with European Standards

It reinforces integration with regulatory initiatives promoted by the European Union and contributes to the harmonisation of processes across Member States.

The Relationship Between RECOPS and EUDAMED

One of the most significant aspects of RECOPS is its connection with EUDAMED, the European database for medical devices.

The European Commission’s strategy aims to progressively centralise regulatory information within interoperable platforms capable of improving traceability, market surveillance and patient safety.

For this reason, healthcare companies will need to become increasingly familiar with EUDAMED, as its role is expected to continue growing in importance over the coming years.

Medical device manufacturers are required to register their products in EUDAMED, a mandatory step before proceeding with registration in the new RECOPS platform.

Would you like to learn more about EUDAMED?

In our article on EUDAMED, we provide an in-depth analysis of who must register and the implications for manufacturers, importers and distributors.

How to Prepare for RECOPS

The introduction of RECOPS provides an opportunity for organisations to review and strengthen their internal compliance processes.

In this context, it is essential to anticipate new requirements, ensure proper integration with EUDAMED and guarantee the traceability of regulatory information.

To ensure a smooth and risk-free transition, partnering with a specialised team is crucial. Our technical experts can support you throughout every stage of the process, answering questions and facilitating compliance with the new regulatory requirements.