Regulation of Medical Devices in Spain by AEMPS

Regulatory Framework

Medical devices in Spain are regulated primarily through EU Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), directly applicable since May 2021 and May 2022 respectively, supplemented by national provisions. AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) acts as the competent authority responsible for oversight, authorisation where required, vigilance, and enforcement. The system ensures devices meet essential safety and performance requirements before and after market placement. Productos sanitarios - AEMPS

Key Responsibilities of AEMPS

• Conformity Assessment and CE Marking: Manufacturers must demonstrate compliance via notified bodies for higher-risk classes (IIa, IIb, III, and certain IVDs); AEMPS designates and supervises notified bodies operating in Spain.
• Registration and Database: All devices placed on the market must be registered in EUDAMED (EU database); national registration requirements apply during transitional periods or for certain low-risk devices.
• Vigilance and Incident Reporting: Manufacturers, importers, and users report serious incidents and field safety corrective actions to AEMPS, which coordinates investigations and communicates risks via national and EU channels.
• Market Surveillance: AEMPS conducts inspections, sampling, and testing to verify compliance; non-compliant devices may be withdrawn or restricted.
• Clinical Investigation Oversight: Approval of clinical investigations for high-risk devices falls under AEMPS authority.

Classification and Requirements

Devices are classified from Class I (self-declared) to Class III (highest risk) under MDR, and A to D under IVDR. Higher classes require involvement of notified bodies and more stringent clinical evidence. Spain applies EU rules uniformly, with AEMPS providing guidance in Spanish and English on specific national procedures.

Practical Implications

Manufacturers must appoint an authorised representative in the EU if based outside; importers and distributors have traceability and vigilance obligations. Healthcare professionals and patients can report concerns via AEMPS channels. The framework aligns with EU-wide harmonisation while allowing national enforcement tailored to Spanish healthcare needs. Detailed information, forms, and guidance are available on the AEMPS website. Productos sanitarios - AEMPS