The Department of Health and Social Care (DHSC) has made an update to its guidance for developers of medical device software (including apps).
Medical device software has developed at a rapid pace in recent years, particularly in the range of health-related apps consumers can install on their devices. Such software ranges from simple monitoring tools to genuine diagnostics, and the level of clinician input varies accordingly with this complexity.
In order to ensure regulations keep up with the development of the technologies, governments must continually review and update their guidance. In this case, DHSC has made the following update:
“4 June 2020
New version published with updated information on clinical calculators, clarification on interpretation of direct diagnosis, addition of new indicative words, IVF products for selection of blastocysts, ECJ Case C 329/16 and Control of Conception.”