Medical Devices Excluded From EU Cyber Resilience Act Proposals
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.
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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.
An expert from the European Union Agency for Cybersecurity (ENISA) has told Medtech Insight that although the new EU Medical Device and IVD Regulations will push developers to make more secure products, regulation is not enough to prevent cyberattacks on devices and digital health systems.
How do the EU’s new cybersecurity guidelines expand on the MDR and fit into the myriad other software-related guidance documents the medtech industry has to consider?