Medical devices that fall within the regulatory scope of the EU’s Medical Device Regulation (MDR) were confirmed to be among the few categories of product excluded from the commission’s draft Cyber Resilience Act in September This was under the logic that sector-specific rules are sufficient to keep products safe from cyberattacks.
This decision was met with a sense of relief from the medtech industry, as manufacturers are already grappling with both the new MDR requirements and, where applicable, horizontal laws around
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