EU: New guidance on cybersecurity published

The MDCG has published new guidance on cybersecurity with respect to medical devices in the form of MDCG 2019-16.

The 46-page document explains the EU's perspective with reference to the fulfilment of the corresponding requirements in Annex I of the regulation on medical devices. Individual chapters deal with the basic concepts, secure design and manufacture, documentation and instructions for use, post-market surveillance and vigilance, as well as other legislation and guidance at EU and international level.

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