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Europe’s ‘Regulatory Lasagna’: Commission Facing Yet More AI Act Criticism

 
• By Eliza Slawther

Is regulating artificial intelligence a good idea? A lawyer questions whether the European Commission’s proposed AI Act is appropriate for medtech, where a growing “regulatory lasagna” could compound notified body capacity issues and SME workload.

MedTech Europe Conference Panel Discussion
Left to right: Sanziana Negreanu Arboreanu, Salvatore Scalzo, Erik Vollebregt, Natalie Gladkov

“I think that the AI regulation still needs some calibrating,” said Erik Vollebregt, legal medtech expert and founding partner at Axon Lawyers (Netherlands), during a recent conference in Brussels.

He noted during a panel discussion that the commission’s draft AI regulation is based on the legal framework used for physical products, but asked whether this approach was appropriate to...

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• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
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Industry Execs Talk Tariff Turbulence During MD&M East

 
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More from Geography

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Health Literacy Issues Cost Major Economies $303B Per Year, Recent Study Shows

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.