The explosion in the use of "medical apps" over the last 10 years has given regulators on both sides of the Atlantic a headache in terms of defining what is a medical device, as well as the sheer volume of apps being produced by thousands of small-scale developers. The focus for this website is on medical device regulation, but this is not the only legislation that app developers need to be aware of.  As we shall see, the majority of medical or 'health apps' do not qualify as medical devices in the regulatory sense, but they are still subject to consumer protection legislation, including national laws derived from the 2001 EU General Product Safety Directive. Conversely, apps that do qualify as software medical devices are not covered by general products safety laws since - like food products and pharmaceuticals - they are separated regulated.

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When is a health-related app a medical device?  

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The vast majority of so-called "wellness" apps (e.g. fitbit type) are designed for relatively healthy people who simply want to monitor their daily exercise regime, heart rate, 'fitness score', etc. They do not meet the strict definition of a medical device in EU or US regulations, so developers of these devices don't have to comply with the specific requirements. In fact the manufacturers of most such devices clearly state that they are "not intended to provide medical or scientific data". In the US the FDA is in the process of de-classifying mobile wellness apps (previously Class 1), as well as most types of CDS software. In the EU (under the MDR17) each app is judged on its own merits, just as for any other piece of standalone medical software. 

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But what about other 'more serious' types of healthcare apps, especially those that allow doctors and other healthcare professionals to view diagnostic medical images on mobile devices, or those that provide diagnostic advice based on the patients's signs and symptoms? These are considered further under the heading of clinical decision support (CDS) software.

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Official guidance:

UK Govt (MHRA): "Medical devices: software applications (apps)", last updated June 2018. Link

US (FDA): 'Mobile medical applications', last reviewed Sept 2022. Link

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This page last updated: 04 May 2023

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