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Connected medical devices are now a commonplace feature in hospital networks and a feature of growing importance in much healthcare provision. In hospitals such devices can include x-ray and ultrasound devices, radiology equipment, monitors, and anaesthesia machines.
In this Bristows webinar, we will explore:
- What?– What devices are covered
- Where? – requirements on the operating environment where a device is to be deployed
- Who? – the interface between manufacturer, systems integrator, operator and end user, and how joint responsibility amongst them may be allocated
- How?– the requirements for a system for continuous cyber risk management and post-market monitoring of evolving cyber threats. What these requirements mean for you.
The MDR, originally scheduled to enter into force in Europe on 26 May 2020, and now deferred by twelve months, contain prescriptive cyber security requirements applicable to medical device manufacturers, healthcare providers and intermediaries in the medical devices supply chain. Draft guidance issued in October 2019 by the International Medical Device Regulators Forum (IMDRF) sets out the principles and practices for medical device manufacturers regarding cyber security. The subsequent guidance issued by the Medical Device Coordination Group (MDCG) in Europe, based on the IMDRF guidance, provides additional colour regarding the requirements of the MDR.
The overarching requirement to incorporate cyber security throughout a product’s entire lifecycle, from product design to post-market surveillance, as well as the focus on joint responsibility for cyber security on the part of manufacturers, health care providers and others pose challenges to current manufacturing processes and legal agreements amongst market participants.