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AIB 2025-1/MDCG 2025-6: Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)

The MDCG has released a guidance document concerning the interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA). This document offers an initial set of answers to the most frequently asked questions concerning the joint application of the Artificial Intelligence Act (AIA) and … Read more

EU Publish AI Continent Action Plan

The EU Commission has published an AI Action Plan. This Communication sets out an ambitious plan of action to drive progress. Artificial Intelligence (AI) is only beginning to take root across key economic sectors, offering solutions to some of today’s most critical challenges. As the full impact of this technological transformation continues to emerge, Europe … Read more

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AI Act has been published in the OJEU

The 12th of July is an important day in the world of AI as it marks the date that the AI act was published in the Official Journal of the European Union (OJEU). This makes it the first comprehensive legislative framework for the regulation of AI systems across the European Union. The EU AI Act … Read more

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EU Council Approves AI Act

The EU Council has approved the very first legislations intended to harmonise Artificial Intelligence. Commonly referred to as the AI Act, this legislation intends on regulating this new emerging technology using a risk-based approach, i.e., the higher the risk, the stricter the rules. AI systems that have limited risk would be subject to light obligation, … Read more

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