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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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.
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.
Medtech companies will avoid the need to comply with yet another EU regulation, it seems, after the European Commission confirmed that proposals to tighten up cybersecurity rules for internet-connected products will not apply to medical devices.