Abstract
Medical devices are instruments, apparatuses, appliances, software, implants, reagents, materials or other articles intended by the manufacturer to be used, alone or in combination, for human beings for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease and which does achieve its principal intended action by pharmacological, immunological or metabolic means. The United Kingdom and the European Union separated and, from 1 January 2021, applied different regulatory requirements and compliance marks to show that medical devices comply with regulatory requirements. Most medical device regulatory framework requirements can be broken down into two broad areas, and the CE and UKCA marks are no different. A regulatory strategy assesses whether a medical technology falls under the medical device regulations, sets out the conformity assessment paths available for a device based on its classification, and includes the quality management system requirements, technical file requirements and clinical evidence requirements.
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