Spanish Legislation on Medical Devices – Overview by AEMPS

Primary EU Legislation

Medical devices in Spain are regulated under the directly applicable EU Regulations:

• Regulation (EU) 2017/745 (Medical Device Regulation – MDR): Applies to most medical devices, fully in force since 26 May 2021 (with transitional provisions).
• Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation – IVDR): Applies to IVDs, fully in force since 26 May 2022 (with transitional provisions).

These replace the former Directives 93/42/EEC, 90/385/EEC, and 98/79/EC. They establish stricter requirements for clinical evidence, post-market surveillance, and notified body oversight. Legislación sobre productos sanitarios - AEMPS

National Implementing Legislation

Spain has adopted several royal decrees and orders to implement and complement the EU Regulations:

• Royal Decree 192/2023: Regulates medical devices and their accessories, detailing national procedures, registration, vigilance, and market surveillance.
• Royal Decree 717/2019: Establishes provisions for in vitro diagnostic medical devices (pre-IVDR full application).
• Royal Decree 1591/2009 (partially in force): Covers legacy aspects during transitional periods.
• Additional ministerial orders and resolutions address specific aspects such as fees, language requirements, and advertising.

AEMPS is designated as the competent authority responsible for enforcement, authorisation of clinical investigations (for certain devices), designation of notified bodies, and coordination of vigilance activities.

Key Regulatory Principles

• Classification: Devices classified from Class I to III under MDR, and A to D under IVDR, determining the level of scrutiny and involvement of notified bodies.
• Conformity Assessment: CE marking required; higher classes involve notified body assessment.
• EUDAMED Registration: Mandatory registration in the European database for traceability and transparency.
• Vigilance and Market Surveillance: Strict incident reporting, field safety corrective actions, and post-market clinical follow-up obligations.
• Clinical Evaluation/Performance: Robust clinical data required, especially for higher-risk devices.

Practical Implications and Resources

Manufacturers, importers, and distributors must comply with EU-wide rules while following Spanish-specific procedures (e.g., national registration during transitional phases). AEMPS publishes consolidated lists of applicable legislation, guidance documents, and updates on transitional arrangements. The framework ensures high protection of public health while facilitating access to safe and effective medical devices. Full texts and detailed information are available on the AEMPS legislation page. Legislación sobre productos sanitarios - AEMPS