Due to the increasing volume of attacks against medical devices, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic medical devices to reduce the risk of patient harm as a result of a cyber incident, as well as protect national health systems. EU regulators are raising the bar on cybersecurity requirements with the European Union Medical Device Regulation (MDR) and the European Union In Vitro Diagnostic Regulation (IVDR), which went into effect May 26, 2021.

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