Industry Calls For Single Conformity Assessments To Cover EU MDR, EHDS And AI Act
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.
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EU Digital Tech Trade Body Weighs In On Medical Device ‘Over-Regulation’ Risk
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.
Cybersecurity In The EU: How Overlapping Regulations Could Harm Medtech
Overlapping EU regulations that relate to medical devices and cybersecurity have been a concern among industry for many months. Medtech Insight asks an expert where, how and why overlap could prove troublesome.
EU Regulatory Roundup, May 2023: MDR Extension Updates Resume
May saw a resurgence of EU MDR news, following a few quieter weeks. Guidance on demonstrating compliance with extended transition periods and compiling clinical investigation reports were among the top-read articles in Medtech Insight in the past month.