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, app users can use this guidance to check if their health app is a medical device, and what to look for to make sure the app is safe and works; software and app developers can use the guidance to identify if their product is a medical device. The guidance serves as an aid to developers in navigating the regulatory system so they are aware what procedures they need to have in place to get a CE mark and what their reporting responsibilities are when things change or go wrong.
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