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.
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