Summary
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).
Content
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.
0 Comments
Recommended Comments
There are no comments to display.
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!
Register a new accountSign in
Already have an account? Sign in here.
Sign In Now