Is an app a medical device?


New guidance is now available from the Medicines & Healthcare products Regulatory Agency (MHRA) for people developing mobile apps to help them comply with regulations and ensure they are safe to use.

As well as medical device apps becoming a growth area in healthcare management in hospital and in the community settings, the role of apps used as part of fitness regimes and for the social care situations is also expanding.

The apps that meet the definition of a medical device are required to be CE marked in line with EU medical device directives to ensure they are regulated and safe. This guidance shows which apps meets the definition of a medical device and includes information on classification, suggestions on how to address the marking process and responsibilities for reporting and correcting when things go wrong. 

The full guidelines can be viewed here

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