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Medtech Industry Weighs In On EMA’s AI Regulation Proposals

 
• By Eliza Slawther

Alignment with other relevant regulations, including medtech, should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence, according to MedTech Europe’s director for international affairs.

The European Medicines Agency's building in Amsterdam
• Source: Alamy

Many of the comments that the European Medicines Agency (EMA) has received so far on its July draft reflection paper that set out its proposed strategy for governing the use of AI in the medicinal product lifecycle relate to the interplay between medical devices and medicines.

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Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
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The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
• By Natasha Barrow

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

More from Geography

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
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Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.