When is an app a medical device? UK Regulator Issues new Guidance
Software that analyses health data could be deemed to be a medical device and become regulated, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.
The UK's medicines and medical devices regulator has issued updated guidance to take account of standalone software and apps.
The MHRA does not regulate data, databases and analytical services as such, but software that analyses or processes data for a medical purpose (such as analysing imaging or genomic data) would be regulated.
Whether something is determined as a medical device would be determined by what the manufacturer states in the device's labelling, instructions for use and any promotional materials. Something may still be deemed to be a medical device despite a disclaimer to the contrary if medical claims are made or implied in the product labelling or promotional literature.
A medical purpose is not typically general fitness, general health and general wellbeing.
Software is unlikely to be a medical device if:
- It simply reproduces a paper document in digital format
- It is up to the health care professional to make decisions based on the advice displayed
- It provides information only without there being any decisions
- It is about lifestyle treatment choices only
However, software is likely to be a medical device if:
- It is linked to a specific medicine or device.
- It is intended to influence the treatment such as dose, size, time, etc.
- It results in a diagnosis or prognosis.
The MHRA gave some examples - apps acting as accessories to physical medical devices such as measuring temperature, heart rate, blood pressure and blood sugar could be a medical device as are programmers for prosthetics and active implanted devices.
There is MHRA guidance available regarding this issue.