The European Commission’s Medical Device Coordination Group has published guidance on preparing manufacturers to meet both premarket and postmarket cybersecurity requirements under the EU’s new medical device regulations. Among the updates in the regulatory overhaul are new safety requirements for all devices that incorporate electronic programmable systems and software. The new rules also require device makers to follow state-of-the-art risk management principles and to establish minimum thresholds for internet technology security measures, including protection against unauthorised access. The overhaul of the EU medical device regulations have been many years in the making and will take effect on May 26, 2020. Read the whole brief here on Medtechdive.

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