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UPDATED GUIDANCE MHRA

Medical device stand-alone software including apps (including IVDMDs)

Updated: 6 September 2022.


This guidance document replaces the previous MHRA guidance titled “medical device standalone

software, including apps”.

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 social care situations is also expanding. However, 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.

But how do developers and users of this software decide whether apps qualify as medical devices and which are for health and fitness purposes? 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.


For developers of software, including apps, we are also including information on classification, suggestions on how to address the main aspects of the UKCA marking process and responsibilities for reporting and correcting when things go wrong.

For users we offer a few tips on how to decide if the app or software device you are using is a medical device and if so how to ensure it is appropriately marked along with how to report problems This guidance is to be used in addition to MEDDEV 2.1/6 and is the UK’s interpretation of

the guidance.


Download the MHRA guidance below

UPDATED GUIDANCE MHRA
.pdf
Download PDF • 2.12MB

Any questions, contact us!




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