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.
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EU medtech companies are subject to many legislative requirements that ensure devices are cybersecure, but more investment in digital literacy is needed to keep Europe safe from cyber breaches, MedTech Europe says in a new policy paper.
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.
Few cybersecurity experts are available to assist during conformity assessments for medical devices, TEAM-NB has said. In light of this, its cybersecurity position paper recommends actions that will help notified bodies in their assessments.