The Spanish Agency of Medicines and Medical Devices (AEMPS) has launched RECOPS, the new electronic application for the Registry of Commercialization of Medical Devices in Spain.
Key Takeaway: RECOPS became operational on June 15, 2026, replacing legacy systems for mandatory commercialization notifications of medical devices in Spain.
What is RECOPS and What is its Purpose?
RECOPS is the national database enabling AEMPS to maintain an up-to-date registry of economic operators and medical devices marketed in Spain.
Its establishment complies with Royal Decree 192/2023 (for medical devices) and Royal Decree 942/2025 (for in vitro diagnostic medical devices - IVD).
Key Functions of the Platform
Through RECOPS, economic operators can:
- Register medical devices marketed in Spain.
- Notify the exact market launch date.
- Upload current documentation: labeling and Instructions for Use (IFU).
- Consult and update submitted communication records.
Who Needs to Comply and Which Products are Included?
A major update with RECOPS is its expanded scope compared to previous systems. Compliance no longer depends on the risk class of the device.
Subject Economic Operators
Registration is mandatory for all economic operators marketing devices in Spain:
- Manufacturers.
- Authorized Representatives.
- Importers.
- Distributors.
- Other economic operators responsible for placing devices on the Spanish market.
Covered Devices and Exceptions
- Included Devices: All medical devices and in vitro diagnostic medical devices (IVD), regardless of risk class (Class I, IIa, IIb, and III).
- Excluded Devices: Custom-made medical devices. These will continue to be managed through the RPS platform.
Key Differences: RECOPS vs. EUDAMED vs. CCPS vs. RPS
It is common to confuse these platforms. Understanding their distinct roles is vital for regulatory compliance:
| Application / Database | Jurisdiction | Current Status / Main Function |
|---|---|---|
| RECOPS | Spain (National) | New mandatory registry for commercialization in Spain. |
| EUDAMED | European Union | EU-wide database. Source of primary product and manufacturer data. |
| CCPS | Spain (National) | Obsolete. Available only for historical record queries. |
| RPS | Spain (National) | Exclusively dedicated to custom-made medical devices. |
Is RECOPS the Same as EUDAMED?
No. EUDAMED is the European database under EU Regulations 2017/745 and 2017/746, whereas RECOPS is Spain's national commercial registry.
RECOPS pulls product data pre-loaded in EUDAMED. Therefore, being registered in EUDAMED does not exempt companies from submitting notifications in RECOPS.
Deadlines and Transitional Period (2026)
AEMPS has established different submission deadlines depending on when the product was notified in EUDAMED:
1. Products Notified in EUDAMED BEFORE May 28, 2026
Subject to a 6-month transitional period. The deadline to complete the RECOPS communication is November 28, 2026.
2. Products Notified in EUDAMED ON OR AFTER May 28, 2026
No transitional period applies. Once the device is visible in EUDAMED, the RECOPS notification must be completed prior to placing the product on the Spanish market.
Frequently Asked Questions (FAQs)
Do I need a digital certificate to access RECOPS?
No digital certificate is required. Access is managed via individual user accounts linked to a corporate email address, where the system sends a verification code for identity authentication.
Can one account manage multiple economic operators?
Access accounts are personal and individual. Each individual acting on behalf of one or more companies must hold a dedicated RECOPS user account.
What happens if there are discrepancies between EUDAMED and RECOPS data?
RECOPS directly retrieves device, manufacturer, and certificate details from EUDAMED. Any inconsistency among EUDAMED, RECOPS, product labels, or IFUs may prevent successful notification or result in regulatory queries from AEMPS.
Next Steps: How to Submit a RECOPS Notification
If your company commercializes medical devices in Spain, start by auditing your UDI-DI status in EUDAMED and preparing updated labeling and IFU files.
👉 Need a step-by-step guide? Read our Practical Guide: Checklist and Step-by-Step RECOPS Registration (Note: Link to Article 2 here).