What is RECOPS?
RECOPS (Registro de Comercialización de Productos Sanitarios) is the database operated by the Spanish Agency of Medicines and Medical Devices (AEMPS, Agencia Española de Medicamentos y Productos Sanitarios) for the registration of medical devices and in vitro diagnostic medical devices (IVDs) intended for marketing in Spain.
RECOPS replaces the previous systems, CCPS and RPS, through which economic operators were required to notify products placed on the Spanish market. The objective is to establish a unified digital registry directly linked to the European database EUDAMED. Before a medical device can be notified in RECOPS, it must first be fully registered in EUDAMED. Product master data are then imported from EUDAMED.
Legal Basis Supplementing the MDR/IVDR (EU)
RECOPS implements registration obligations arising from two Spanish Royal Decrees that further specify the requirements of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 at national level:
- Real Decreto 192/2023, dated 21 March 2023, governs medical devices in general (implementation of the MDR). Article 18 requires economic operators to register electronically with AEMPS before commencing marketing activities.
- Real Decreto 942/2025, dated 21 October 2025 (effective since 24 October 2025), governs in vitro diagnostic medical devices (implementation of the IVDR). Article 15 establishes the registration obligation for IVD products.
Both decrees provided for the gradual introduction of the national register. Until full implementation, the predecessor regulations (Royal Decree 1591/2009 and Royal Decree 1662/2000) remained applicable on a transitional basis. With the launch of RECOPS in June 2026, this transitional period has come to an end.
Exception for custom-made devices: Manufacturers of custom-made devices (productos a medida) are not subject to RECOPS. For these products and the responsible parties involved, the RPS (Registro de Responsables de la puesta en el mercado de productos a medida) remains the relevant register.
Key RECOPS Implementation Dates
| Date | Event |
| 21 March 2023 | Real Decreto 192/2023 published (legal basis for medical devices) |
| 21 October 2025 | Real Decreto 942/2025 published (legal basis for IVDs) |
| 27 May 2026 | Final day for new submissions through the legacy CCPS/RPS systems |
| 28 May 2026 | CCPS/RPS available in read-only mode (no new submissions possible) |
| 15 June 2026 | RECOPS goes live as the mandatory new registration system |
Who Is Responsible for Registration in RECOPS?
All economic operators are required to register in RECOPS. They are also responsible for registering the products they place on the Spanish market, regardless of whether those products have already been registered by another economic operator that also distributes them.
The registration obligation therefore applies to all economic operators placing medical devices or IVDs on the Spanish market, including:
- Manufacturers (including those based outside Spain, provided they market products in Spain)
- Authorized Representatives
- Importers
- Distributors placing products on the Spanish market
Pharmacies and other establishments that exclusively sell products directly to the public are exempt from this obligation.
What Changes for Manufacturers?
RECOPS replaces the previous CCPS and RPS systems. All new registrations must now be submitted through RECOPS. Access to the Spanish market through RECOPS depends on prior registration of UDI data in EUDAMED. Without a complete and published EUDAMED registration, a RECOPS notification cannot be submitted.
- Registration Before Market Placement: As with EUDAMED, products must be registered before marketing activities begin. A six-month transitional period currently applies to products that were placed on the market before 28 May 2026 (with the transition period ending on 27 November 2026). Manufacturers have a maximum of six additional months to register it in RECOPS once a device, that is covered by this transitional period, is registered in EUDAMED.
- Product Data Requirements: The following information must be provided, among others:
- Economic operator identification details
- Product trade name
- UDI-DI identifier
- Labelling information
- Instructions for Use (IFU), at minimum in Spanish
- Date of market placement in Spain
- Practical Implications: The quality of UDI data in EUDAMED becomes even more critical, as potential errors are transferred into a second database, RECOPS. Regulatory and product management teams should therefore thoroughly verify the accuracy of product master data and compliance with EUDAMED UDI requirements.
- Annual Update Requirement: Economic operators must review and update their information in the commercialisation register annually (Registro de comercialización indicando los productos). If the required update is not performed, both the economic operator’s registration and all associated products will be removed from the register.
- Risk of Sanctions: Failure to comply with registration obligations may be classified as an administrative infringement and may be sanctioned under the Spanish medical device enforcement regime established in Royal Legislative Decree 1/2015. The amount of any financial penalties depends on the nature and severity of the infringement.
RECOPS Registration Is Not Possible Without Correct EUDAMED UDI Data
The quality of data stored in EUDAMED is decisive for RECOPS. UDI information can only be entered into RECOPS once the corresponding UDI registration has been completed in EUDAMED. The registration is only possible if a medical device has been fully and correctly registered in EUDAMED and is visible within the database.
How Are UDI Data Transferred from EUDAMED to RECOPS?
Once an economic operator has registered in RECOPS, UDI data can be imported from EUDAMED through an integrated interface with search functionality.
The imported data must then be supplemented with information required exclusively by RECOPS, including:
- Date of market placement in Spain
- Spanish product label
- Spanish Instructions for Use (IFU)
As a result, the compliance and quality of EUDAMED data are a prerequisite for successful Spanish market registration. If EUDAMED contains incorrect, inconsistent, or incomplete UDI master data, the device may not be found in RECOPS or the data may not be imported correctly.
Despite maintaining its own national register, Spain effectively relies on EUDAMED as the primary source of product master data.
Supporting RECOPS Compliance with the mytracekey UDI Manager
This is precisely where the mytracekey UDI Manager comes into play. It helps medical device manufacturers submit UDI data to EUDAMED accurately and compliantly, thereby establishing the basis for a smooth RECOPS registration process.
Through comprehensive validation against EUDAMED business rules, data can be checked and corrected before submission to EUDAMED. This ensures that only complete and compliant UDI data enters both EUDAMED and RECOPS.
Looking for a way to validate your UDI data before EUDAMED submission? Join one of our non-binding software demonstrations to find out whether the mytracekey UDI Manager is the right solution for your organisation.
EUDAMED as the Foundation of an International UDI Strategy
The close integration between RECOPS and EUDAMED demonstrates that the quality of EUDAMED data will become increasingly relevant beyond the European database itself. For manufacturers, maintaining a consistent and complete data foundation is becoming essential for efficiently meeting national registration requirements.
RECOPS may serve as an example of a broader trend in which EUDAMED increasingly becomes the foundation for additional national UDI systems.
The significant effort already invested by manufacturers in collecting all UDI-relevant attributes for EUDAMED provides a strong basis for a global UDI strategy. The key challenge is to maintain and organise this data in a way that makes it readily available for other UDI databases and supports efficient UDI processes.
A UDI management platform such as the mytracekey UDI Manager provides exactly such a framework by enabling the centralised management of UDI data across multiple regulatory regimes.