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Ricardo Costa Macedo, Lawyer and Partner in the Intellectual Property Department, Adriana Magalhães, Lawyer, and Inês Henriques, Junior Lawyer, address the topic of a Three-Decade Journey: Medical Devices Regulation in Portugal.
Articles 20/03/2024

Portugal is celebrating thirty years of regulation of medical devices, it being apparent that the relevant legislation has improved in terms of rigor, safety. system credibility and market permeability. and that the lnfarmed. I.P. has played an active role in this field since the 1990s.

Over the last three decades. medical devices have played an immeasurable role in transforming healthcare. As a vital link between technological innovation and the health of citizens. Medical devices provide new and appropriate solutions for prevention. diagnosis, and treatment of various pathologies. leading to better and more efficient disease management. healthier. more independent and active ageing. and the extension of Life.

According to Article 2(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, the universe of medical devices covers any instrument. apparatus, equipment. software. implant. reagent material or other article intended for use in humans for medical purposes and whose principal intended effect is not achieved by pharmacological immunological or metabolic means.

Read the full article: A Three-Decade Journey: Medical Devices Regulation in Portugal

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Practice Areas

  • Life Sciences