A new guide has been published by the Spanish Agency of Medicines and Medical Devices (AEMPS), providing a consolidated reference for regulatory requirements applicable to the marketing of medical devices in Spain.
For the first time, this guide consolidates the national requirements established in Royal Decree 192/2023 with the European regulatory frameworks set out in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The result is a single, cohesive reference document for companies seeking to market medical devices in Spain.
Key topics covered include:
- Transitional provisions for “legacy” devices
- Obligations of economic operators (manufacturers, importers, distributors, authorised representatives)
- Conformity assessment procedures
- EUDAMED-related processes
- Vigilance and post-market surveillance requirements
- A dedicated section on custom-made devices, including guidance on their manufacture and placement on the market
This guide is an essential tool for all stakeholders in the medical device sector, offering clear and practical information to support regulatory compliance and facilitate market access in Spain.
Access the full guide here:
https://www.aemps.gob.es/productosSanitarios/docs/2025/guia-comercializacion-ps-2025.pdf
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