MedTech Europe recently published two position papers on the latest development on strength, resilience, and competitiveness policies in the medical technology sector. With the first…
MedTech Europe calls for aligned implementation of AI Act with MDR & IVDR
In its press release, published on 1 August 2025, marking one year since the entry into force of the Artificial Intelligence (AI) Act, MedTech Europe…
AI medical devices: how the AI Act impacts the MDR and IVDR
In June 2025, the MDCG published its sixth new guidance of the year: MDCG 2025-26. This document provides answers on certain aspects of the interplay…
Artificial Intelligence Act just released
Today, 12 July 2024, the Artificial Intelligence Regulation (AI Act) was published in the Official Journal of the European Union. Regulation (EU) 2024/1689 sets harmonised…
Parliament approved the Artificial Intelligence Act
Today, 13 March 2024, the European Parliament approved the text of the Artificial Intelligence Act. In December 2023, Members of the Parliament endorsed the AI…
Regulatory requirements for AI medical devices
In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI Act). Lawmakers have already started their negotiations to define the…