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Why and How to regulate software in the healthcare setting - Part 1

Software intended for clinical use, under the Medical Device Regulations (or their local equivalents), may be classified as a Medical Device, and subject to the relevant requirements and constraints. The group producing the software are classed as “the manufacturer”. Using the software clinically in-house (“putting it into service”) requires demonstrating a certain level of manufacturer quality control. Giving or selling the software to another hospital (“putting it on the market”) requires that it be CE or UKCA marked. CE/UKCA marking is not a defence against harm caused to patients through use of the software; rather, it is one sign of the manufacturer’s due diligence.

The purpose of these two webinars is to highlight and draw out strategies through this complexity, within the context of the health system, academia and patient communities.