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 6, 2026
Approximately 5 minutes
Breast Implants Regulation and Vigilance in Spain – AEMPS Guidance
Breast Implants Regulation and Vigilance in Spain – AEMPS Guidance
Regulatory Framework
Breast implants are classified as Class III medical devices under Regulation (EU) 2017/745 (MDR) and are subject to the highest level of scrutiny. In Spain, AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) acts as the competent authority, ensuring compliance with EU requirements while implementing national vigilance and patient safety measures. All breast implants must bear the CE marking following conformity assessment by a notified body. Prótesis mamarias - AEMPS
Manufacturer and Notified Body Obligations
- Manufacturers must conduct thorough clinical evaluations, including long-term safety data.
- Notified bodies perform rigorous assessments, including unannounced audits.
- Post-market clinical follow-up (PMCF) plans are mandatory, with emphasis on rupture rates, capsular contracture, and rare complications such as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
Vigilance and Reporting Requirements
- Manufacturers must report serious incidents (e.g., ruptures, infections, BIA-ALCL cases) to AEMPS without delay.
- Annual summary reports on ruptures and other complications are required.
- Field safety corrective actions (FSCA) and field safety notices (FSN) are coordinated through AEMPS and the EU vigilance network.
- AEMPS monitors trends and may trigger safety reviews or product restrictions if signals emerge.
Patient Registry and Information
- Spain operates a national registry for breast implant patients to facilitate long-term follow-up and epidemiological studies.
- Patients receive detailed information cards from manufacturers, including implant details, serial numbers, and recommendations for regular check-ups.
- Healthcare professionals are encouraged to report adverse events via AEMPS channels.
Specific Safety Concerns Addressed
AEMPS actively addresses known risks such as:
- BIA-ALCL: Linked primarily to textured implants; monitoring includes case reporting and guidance on diagnosis/treatment.
- Silicone gel leakage and implant rupture: Emphasis on imaging follow-up (MRI/ultrasound).
- Chronic pain, autoimmune symptoms, and other patient-reported issues.
Regular updates and safety communications are issued based on emerging data.
Practical Advice for Patients and Professionals
Patients considering breast implants should discuss risks/benefits with qualified surgeons and verify CE marking. Professionals must ensure proper documentation and prompt reporting. AEMPS provides patient information leaflets, professional guidance, and a dedicated section for breast implant safety. This comprehensive approach prioritizes patient protection while allowing access to approved devices. Prótesis mamarias - 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
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.