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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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• Source: Shutterstock

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 position paper published...

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