UK:
UK's MHRA Issues Guidance On Health Apps
14 November 2016
Jones Day
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On August 25, 2016, MHRA issued updated guidance to help identify the health apps that
are medical devices and make sure they comply with regulations and
are acceptably safe. The guidance is presented as a step-by-step interactive PDF. Aimed at both users and
developers, users can use this guidance to check if their health
app is a medical device and to determine what to look for to make
sure the app is safe and works. In addition, the guidance serves as
an aid to developers in navigating the regulatory system so they
are aware of procedures they need to have in place to get a CE mark
and applicable reporting responsibilities.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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