Submitting a commercialization notification through RECOPS (Registro de Comercialización de Productos Sanitarios) is a mandatory requirement for economic operators marketing medical devices in Spain.
Because RECOPS imports primary device data directly from EUDAMED, proper preparation is essential to prevent registration errors or regulatory queries from the Spanish Agency of Medicines and Medical Devices (AEMPS).
Pre-Submission Checklist: What to Prepare Before Logging In
To ensure a smooth notification process, gather and verify the following elements before initiating your filing in RECOPS:
1. EUDAMED Verification
- [ ] Manufacturer Registration: Ensure the manufacturer is active and fully registered in EUDAMED.
- [ ] Device Visibility: Verify that the target UDI-DI is correctly registered and set to visible in EUDAMED.
- [ ] Valid Certificates: Check that all applicable CE certificates are active and properly linked in the European database.
2. Marketing & Technical Documentation
- [ ] Commercial Launch Date: Determine the exact initial market placement date in Spain.
- [ ] Current Product Labeling: Prepare the official labeling file (in PDF format) corresponding to the device sold in Spain.
- [ ] Instructions for Use (IFU): Prepare the current IFU document (in PDF format) in Spanish.
3. Account Access Requirements
- [ ] Corporate Email: Dedicated email address to receive authorization security codes.
- [ ] Economic Operator Data: Valid company identification and contact details.
Important: No digital certificate (eID) is required to access RECOPS. Authentication relies on individual user accounts validated via email code verification.
Step-by-Step Guide: Submitting a Commercialization Notification
Once your documentation is ready and verified against EUDAMED, follow these steps to register your product in RECOPS: