Information on when software applications are considered to be a medical device and how they are regulated written by the Medicines & Healthcare products Regulatory Agency (MHRA).
This guidance document replaces the previous MHRA guidance 'Medical device standalone software, including apps'. The guidance uses flowchart examples to show which standalone software and apps meet the definition of a medical device, an in vitro diagnostic device or active implantable medical device and therefore require to be CE marked, and those which do not. This guidance is to be used in addition to MEDDEV 2.1/6 and is the UK’s interpretation of the guidance.
MHRA: Medical device stand-alone software, including apps (including IVDMDs) (last updated 20 June 2018) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/717865/Software_flow_chart_Ed_1-05.pdf
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