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Guidance on Cybersecurity for Medical Devices published to support the implementation of the MDR and IVDR

Posted on 06.02.2020

The Medical Device Coordination Group (MDCG) endorsed the Guidance on Cybersecurity for medical devices, which was made available online on 6 January 2020. This document aligns with cybersecurity guidance from the International Medical Device Regulators Forum (IMDRF) and aims to help manufacturers fulfil all the relevant Cybersecurity requirements in Annex I of the MDR and IVDR. In addition, the guidance explains both the premarket and postmarket requirements to assist companies ensuring an adequate balance between the benefits and risks during all the device’s possible operation modes and provides additional considerations regarding expectations from actors other than manufacturers.

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