Information on when software applications are considered to be a medical device and how they are regulated.
Guidance on what a software application medical device is and how to comply with the legal requirements.
Read the statement on the launch of the guidance
For full functionality, this document is best viewed in Acrobat reader.
Published: 8th August 2020
Source: GOV UK, Medicines and Healthcare products Regulatory Agency
Page URL: https://www.gov.uk/government/publications/medical-devices-software-applications-apps