When conducting a CSC, the digital solution should be assessed in line with current UK regulations as set out by The Medicines and Healthcare products Regulatory Agency (MHRA) to determine if it could be classified as a medical device or, more specifically, Software as a Medical Device (SaMD).

NCISS offers a MDR Clinic service where a digital solution can be assessed against the MHRA guidance to determine if it is likely to be a medical device. More details on the MDR Clinics and Quality Management Systems can be found on our website.

NB. If a digital solution is not initially classified as a medical device but it is further developed, or there are changes in use of any of the component products, then the assessment must be reviewed to determine if this affects the classification, and identify any follow-on impact.