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Industry Calls For Single Conformity Assessments To Cover EU MDR, EHDS And AI Act

 
• By Eliza Slawther

Who should be responsible for conducting conformity assessments for medical devices in the context of the digital and data laws that sit alongside the EU MDR and IVDR? MedTech Europe says manufacturers should be able to follow a single conformity assessment route where possible.

Assessment
• Source: Shutterstock

The European Health Data Space (EHDS) has impressed trade body MedTech Europe ̶ unlike some other proposed horizontal EU legislations around data and digital products. The organization described the EU’s planned ecosystem of rules and standards in a 22 February position paper as a “pioneering initiative” that will “herald a new era of health data sharing” across the continent.

This enthusiastic reception to the European Commission’s draft EHDS regulation contrasts somewhat with MedTech Europe’s more skeptical stance on other upcoming EU regulations, namely the Artificial Intelligence (AI) Act and the Data Act

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FDA Announces Classifications On 8 Device Types

 
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