The Spanish Agency for Medicines and Medical Devices ("AEMPS") has updated the information on the surveillance system for medical devices and the functions of the person responsible for surveillance of health centres. The revision – published on May 4, 2026, and prepared with the Technical Inspection Committee – aligns the Spanish surveillance system with the current European framework (MDR/IVDR) and reinforces key obligations in incident reporting, alert management and implant traceability.
What's New
The update replaces the 2015 version and aligns this system with the legal framework currently in force. Among the highlights are:
- Person responsible for surveillance. Centres with internment and major outpatient surgery must formally designate a person responsible for surveillance of medical devices, with defined functions and the ability to liaise with the competent authority. In the rest of the centres, the responsibility falls on the medical director or health manager who appears in the Register of Health Centres and Services of the corresponding autonomous community.
- Reporting of serious incidents and potentially serious incidents. Professionals and facilities must report any failure of a product that has caused or could have caused death, serious deterioration of health or threat to public health. The guidance stresses that potential incidents averted by staff intervention or fortunate circumstances should also be reported. The way to report these incidents will be the NotificaPs Portal.
- Dialogue and documentary support. The surveillance manager acts as a point of contact with the authorities, coordinates the collection of evidence and manages, when appropriate, the delivery of samples to the manufacturer.
- Alerts and corrective actions. The centres must have standard working procedures that ensure the reception, dissemination and effective implementation of information notes and alerts issued by the AEMPS, coordinating the services involved and documenting the execution.
- Implant traceability. The use of implant cards is reinforced to facilitate patient identification and ensure access to product information. They must be completed with details of the patient, the centre and the intervention, and given to the patient at least in Spanish along with warnings and precautions from the manufacturer.
Conclusion
The update of the AEMPS guide consolidates a more proactive surveillance model, focused on prevention and traceability.
For more information, do not hesitate to contact our Cuatrecasas specialists through the Knowledge and Innovation Area.
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