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MDCG unveils MDR, IVDR cybersecurity guidance

A guidance on meeting premarket and postmarket cybersecurity requirements under the Medical Devices Regulation and the In Vitro Diagnostic Regulation has been released by the European Commission's Medical Device Coordination Group. Manufacturers are advised to take into account cybervulnerability exploitations that are likely to result from "reasonably foreseeable misuse," MDCG notes. Regulatory Focus (1/6)

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