UK guidance on stand-alone medical device software including apps issued

EU MDR I general guideline document applying to all medical devices marketed in Europe however for UK MHRA has come out with new guideline which has to be followed if product must be marketed in Great Britain (This contains England, Wales and Scotland) like CE Mark which is recognised for Europe UKCA mark will be required for product marketed in Great Britain. (CE marked product will be allowed till June 30,2023) UKCA stands for UK Conformity Assessed.

The new guideline replaces previous guideline. This is helpful for developer as well as user as it gives various examples to fall standalone software into medical device or not.

The guidance is meant to assist developers of software and apps in navigating the regulatory system so as that they are conscious of the procedures.

With rapid progress of development of software for diagnosing, predicting and advisory software based on data entered or captured from another device when connected, all need to be controlled and thus covered under same guideline applicable to medical device.

The use of medical device applications (apps) is growing for healthcare management in hospitals and therefore the community, in social care settings and as a component of private wellness and fitness monitoring. Standalone software and apps that meet the definition of a medical device are required to be CE marked in accordance with the EU regulatory requirements, and UKCA marked for UK as per MHRA to make sure they are safe to use and perform within the intended manner.

The UK Medicines and Healthcare products regulatory authority (MHRA) has issued updated guidance to assist identify the health apps which are medical devices. . It also provides guidance on the likely classification of the device. It should be remembered that other jurisdictions also have guidance on medical apps, like the US FDA Policy for device software functions and mobile medical applications.

The guidance document provides interactive flow charts to guide deciding on whether the software or app: falls in medical device category or not. Some explicit examples are given for guideline.

1. It has an intended medical purpose and not merely administrative purpose like monitoring consultant’s visit, gathering data for doctor.

2. It may be a medical device or in vitro diagnostic medical device.

Symptom checkers are independent software intended to be used by lay persons, who manually enter details or symptoms and therefore the software matches these with conditions. The guidance lists samples of such software that would be a medical device as including software that indicate:

1. a subset of medical conditions that match the symptoms.

2. the likelihood of a match with a medical condition.

3. treatment recommendations for listed conditions.

4. a sign of seriousness of potential conditions.

It gives very clear guidance with some examples about accessory (software linked to medical device for monitoring to record data.

There is no definition of system module in UK MDR 2002 but in new guideline this is clearly clarified.

Intended purpose by description can become device or excluded is also defined. (like the manufacturer makes the claim of intended medical purpose but may write on label that this is not medical device will not be acceptable) All software that provides clinical diagnosis, clinical decisions and calculate clinical risk.

In organ donor case, software which determines safety and compatibility with potential recipient.

Software which monitors therapeutic measures.

Software claiming output from physical device preventing or treatment of specific dieses.

Software that can compensate for injury or handicap like magnifying text for visually impaired (but the same software does not claim for visually impaired people then it does not fall under medical device)

This updated advice gives insight into the MHRA approach to varied sorts of health software and apps. it will be helpful in distinguishing software and apps that fall within and out of doors the regulatory requirements for medical devices in UK. As such, it will be of interest to medical device manufacturers and technology companies performing on software and apps within the health and wellness fields.