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  • Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose in the context of medical care. NOTE: Medical monitoring refers to delivery of medical diagnosis and established treatment linked to a specific disease, and does not include monitoring of patient safety or well being in the context of tracking subject status during clinical trials. Such a medical purpose is a key in establishing that a given instrument, software program or measuring device is subject to regulations pertaining to a medical device. [After MHRA Guidance: Medical device stand-alone software including apps] See also medical device; DSMB, clinical trial, non-interventional trial.
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