- Medicines and Healthcare products Regulatory Agency
- Part of:
- Regulatory guidance for medical devices, Patient safety, and Medical devices regulation and safety
- 8 August 2014
- Last updated:
- 29 September 2017, see all updates
Information on when software applications are considered to be a medical device and how they are regulated.
Published: 8 August 2014
Updated: 29 September 2017
- Document updated with link to new Introductory Guide to new medical device regulations.
- Updated guidance in attached document.
- Updated software guidance. Minor changes and clarification.
- We have updated the format of the guidance. It is now an interactive PDF.
- Updated links to Europa.eu pages
- First published.