Implantable Medical Devices Registry in Spain – AEMPS System

Purpose and Legal Basis

The Registro de Productos Sanitarios Implantables (RPSI), managed by AEMPS, is a national traceability system for implantable medical devices. It supports patient safety by enabling long-term follow-up, rapid identification in case of adverse events, and effective post-market surveillance. The registry operates under Regulation (EU) 2017/745 (MDR), particularly Article 69 and Annex XIV, and Spanish implementing legislation (Royal Decree 192/2023). It complements the EU EUDAMED database while addressing national needs during transitional periods and for specific high-risk implants. Registro de productos implantables - AEMPS

Scope of Devices Covered

The registry includes implantable devices intended to remain in the body for at least 30 days or permanently, such as:

• Cardiovascular implants (e.g., pacemakers, stents, heart valves)
• Orthopaedic implants (e.g., hip/knee prostheses, spinal devices)
• Breast implants and tissue expanders
• Neurostimulators and cochlear implants
• Intraocular lenses and certain urological/gynaecological implants

Custom-made implantable devices and certain active implantable devices are also subject to registration obligations.

Registration Process and Obligations

• Who registers: Manufacturers (or authorised representatives for non-EU entities) must register each implantable device model before placing it on the Spanish market.
• Information required: Unique Device Identification (UDI), device description, manufacturer details, intended purpose, expiry dates (where applicable), and patient information card details.
• Patient-level data: For certain high-risk implants, pseudonymised patient data (e.g., implant date, surgeon, serial/UDI) must be recorded to enable long-term tracking.
• Timing: Registration occurs prior to commercialization; updates are required for changes or withdrawals.

Healthcare providers implanting devices contribute by ensuring accurate recording and reporting to the registry when required.

Vigilance and Patient Safety Benefits

The registry enables:

• Rapid identification of patients in case of field safety corrective actions or recalls.
• Monitoring of long-term performance and complication rates (e.g., rupture, migration, infection).
• Epidemiological analysis of adverse events, including rare conditions such as BIA-ALCL associated with breast implants.
• Direct patient notifications when necessary via the implant card system.

AEMPS uses registry data for signal detection, risk assessment, and coordination with EU vigilance networks.

Practical Implications

Manufacturers must integrate registry obligations into their quality management systems. Patients receive an implant card with key information and are encouraged to participate in follow-up. Healthcare professionals should verify registration status and report incidents promptly. The system enhances traceability and public health protection for implantable devices in Spain. Detailed guidance, forms, and access instructions are available on the AEMPS implantable devices registry page. Registro de productos implantables - AEMPS