Healthcare: Medical Devices 2025

Fernanda Matoso and Alessandro Azevedo are the authors of the Portugal chapter in Healthcare: Medical Devices 2025, one of Chambers and Partners’ Global Practice Guides, which brings together contributions from leading lawyers across multiple jurisdictions and provides an up-to-date comparative analysis of the main legal challenges in the medical devices sector.

In the Portugal chapter, the authors examine in detail the legal framework applicable to medical devices, largely shaped by European legislation, with particular reference to Regulations (EU) 2017/745 and 2017/746 and to the new national regime approved in 2024. The chapter covers the entire product life cycle, from design and manufacture to post-market obligations, including surveillance, corrective actions and recalls, offering a practical perspective for economic operators active in Portugal.

The analysis also addresses key issues such as advertising and promotion rules, marketing and sales, enforcement mechanisms by the competent authorities — in particular INFARMED — as well as the different administrative and civil liability regimes applicable to medical devices and other healthcare products. Particular attention is given to borderline products and digital technologies, including medical software and digital health solutions, in a rapidly evolving regulatory environment.

Healthcare: Medical Devices 2025 provides a comprehensive and practical overview of product safety regimes, liability, commercialisation and enforcement, as well as emerging topics such as sustainability, corporate social responsibility, advertising and product claims, interaction with regulatory authorities and the growing impact of artificial intelligence in the healthcare sector.

Please refer to the full chapter attached.