Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 8, 2026
Approximately 5 minutes
National Registers of Medical Devices and IVDs in Spain – AEMPS Overview
National Registers of Medical Devices and IVDs in Spain – AEMPS Overview
Purpose of National Registers
The national registers managed by AEMPS serve to:
- Ensure traceability of medical devices and IVDs throughout their lifecycle.
- Facilitate market surveillance, vigilance, and post-market activities.
- Support compliance during the transitional periods of MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).
- Provide a centralized database for competent authority oversight and public transparency.
These registers complement the European EUDAMED database and apply particularly to devices not yet fully transitioned or requiring national-specific obligations. Registros nacionales de productos CCPs/RPS - AEMPS
Main Registers and Databases
- Registro de Productos Sanitarios (RPS): The core national register for medical devices and IVDs placed on the Spanish market.
- Mandatory for Class I self-certified devices, custom-made devices, systems/procedure packs, and certain legacy devices during transition.
- Includes device identification, manufacturer/responsible person details, and status updates.
- Registro de Operadores: Registry of economic operators (manufacturers, importers, distributors) involved in medical devices and IVDs.
- Registro de Instalaciones: Registry for facilities where devices are manufactured, stored, or distributed.
- EUDAMED Integration: National data feeds into the EU database; transitional national registration remains required until full EUDAMED functionality.
Registration Requirements
- Who must register: Manufacturers (or authorised representatives for non-EU entities), importers, and distributors for applicable devices.
- When: Before placing on the market or during transitional periods for legacy devices.
- Information required: UDI (where applicable), device classification, intended purpose, labelling details, responsible person, and conformity assessment details.
- Language: Information submitted in Spanish; labelling and instructions must meet national requirements.
Failure to register can lead to market restrictions, administrative sanctions, or product withdrawal.
Vigilance and Surveillance Linkage
Registered devices are monitored through the vigilance system:
- Serious incidents and field safety corrective actions reported directly to AEMPS.
- AEMPS coordinates investigations, risk assessments, and communications.
- Data from national registers support rapid identification and action on non-compliant or unsafe products.
Practical Guidance
AEMPS provides online portals for registration, detailed instructions, FAQs, and updates on transitional provisions. Manufacturers and operators should consult the registers section for current requirements, especially during the ongoing MDR/IVDR transition. The system enhances patient safety and regulatory efficiency in the Spanish market while aligning with EU harmonisation goals. Registros nacionales de productos CCPs/RPS - AEMPS
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Marketing and Placing on the Market of Medical Devices and IVDs in Spain
In Spain, medical devices and in vitro diagnostic medical devices (IVDs) must comply with EU MDR/IVDR requirements for marketing and placing on the market, including CE marking, registration in EUDAMED, Spanish national registration obligations during transitional periods, and vigilance reporting to AEMPS to ensure traceability and safety.
Approximately 5 minutes
Breast Implants Regulation and Vigilance in Spain – AEMPS Guidance
AEMPS maintains strict oversight of breast implants in Spain under EU MDR, requiring CE marking, manufacturer vigilance, annual reporting of ruptures and complications, patient registries, and rapid response to safety signals such as BIA-ALCL and other adverse events.
Approximately 5 minutes
Commercialization of Medical Devices in Spain – AEMPS Requirements
In Spain, commercialization of medical devices requires full compliance with EU MDR/IVDR, including CE marking, EUDAMED registration, Spanish national registration for certain devices, proper labelling in Spanish where required, and ongoing vigilance obligations to AEMPS for safe market placement and use.