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.
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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.
EU Data Act Must Consider ‘Sectoral Peculiarities’ Says Medtech Industry
The European Commission’s proposed Data Act is among a growing pile of horizontal regulations set to impact the medtech industry. But changes should be made to protect trade secrets and other sector-specific nuances, MedTech Europe warns.
EU Cyber Resilience Act Should Include Medtech, Says Data Protection Watchdog
The European Commission’s decision to exclude medical devices from the scope of its proposed Cyber Resilience Act was praised by industry, but this could all change, as the EU’s data protection supervisor argues that medtech should be included in the legislation.