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UK MHRA's Guidance: Software Applications (apps)

Recently the MHRA updated its Medical devices: Software Applications (apps) guidance, which provides information on when software applications are considered to be medical devices and how they are regulated.


This guidance details what a software application in medical devices is and how to comply with the legal requirements.

This guidance uses examples within flowcharts to show which standalone software and apps meet the definition of a medical device, an in vitro diagnostic device or active implantable medical device and are required to be UKCA marked, and those which do not.


As per MEDDEV 2.1/6 - 2016, “software” is defined as a set of instructions that processes input data and creates output data.


This includes:

• Un-compiled software - if all of the information is provided to install the software then the regulations may apply.

• Freeware / open-source software


In the UK, standalone software and apps that meet the definition of a medical device are still required to be UKCA marked in line with the Medical Device Regulations 2002 (as amended) (UK MDR 2002) in order to ensure they are regulated and acceptably safe to use and also perform in the way the manufacturer/ developer intends them to.


Click this LINK to know more about the guidance on "Medical device stand-alone software including apps (including IVDMDs)"

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