The European Commission’s Medical Device Coordination Group published guidance aimed at preparing manufacturers to meet both premarket and postmarket cybersecurity requirements under the EU’s new medical device regulations.
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 unauthorized access.
The purpose of the new guidance document is to help manufacturers fulfill all essential cybersecurity requirements of the MDR and IVDR. The new regulations ask device makers to incorporate updated practices as they design, develop and upgrade products across their life cycle. They must take into account principles of risk management including information security, verification and validation.
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR) (hereaftercalled the Medical Devices Regulations) have been adopted and entered into force on 25 May 2017.The two Regulations, which are to replace three EU Directives1, apply progressively until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
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 unauthorized access.
The purpose of the new guidance document is to help manufacturers fulfill all essential cybersecurity requirements of the MDR and IVDR. The new regulations ask device makers to incorporate updated practices as they design, develop and upgrade products across their life cycle. They must take into account principles of risk management including information security, verification and validation.
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR) (hereaftercalled the Medical Devices Regulations) have been adopted and entered into force on 25 May 2017.The two Regulations, which are to replace three EU Directives1, apply progressively until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
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