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EU Digital Tech Trade Body Weighs In On Medical Device ‘Over-Regulation’ Risk

 
• By Eliza Slawther

While the European Health Data Space and its objectives should be a positive regulatory development for the EU health sector, DIGITALEUROPE stresses that the risk of counterproductive conflicts with other proposed laws around AI and data must be addressed.

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Medtech trade bodies and legal experts have long warned that manufacturers of medical devices will face a litany of new regulations over the coming years. The European Commission has announced intentions to roll out new legislation spanning product and organization cybersecurity, data sharing and artificial intelligence (AI) that will add to the existing Medical Device Regulation pressures for medtech firms.

DIGITALEUROPE, a trade body that describes itself as representing “digitally transforming industries” across Europe, is the latest to offer its views on the topic. In a

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

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

 
• By Brian Bossetta

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More from Geography

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.