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EU Regulating AI ‘Like A Microwave’ When Focus Should Be Its Ability To Cook

 
• By Eliza Slawther

Concerns are mounting over how the EU’s AI Act will impact the medtech sector. Now, a computer science expert has argued that the proposed regulation is fundamentally flawed in its approach, because it puts the focus on the AI product instead of its output.

AI Doctor
• Source: Shutterstock

The European Commission’s proposal for a horizontal regulation that applies to all artificial intelligence (AI) products has been largely met with skepticism from stakeholders across the medtech industry. So far, much of this criticism has focused on the overlap between the AI Act and other regulations in the EU, such as the sector-specific Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR).

A wider perspective on the AI Act and its “fundamental problem” was offered by a philosopher and computer ethics professor...

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Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 
• By Brian Bossetta

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Global Medtech Guidance Tracker: June 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.