Maliha Carey, from legal firm, Stevens & Bolton asks is your app a medical device and why does it matter?
Health apps have surged in popularity recently and are now used daily on smartphones and tablets worldwide. In certain circumstances, health apps may be classified as medical devices and are therefore subject to a number of different regulatory requirements. The Medical and Healthcare products Regulatory Agency (MHRA) has recently published updated guidance, intended to assist app developers and manufacturers of medical devices in assessing whether their product is a medical device, and ultimately help ensure compliance.
Is your app a medical device?
An app will be classified as a medical device if it has as its intended purposes one or more of the “medical purpose(s)” set out in the legislation:
- prevention of disease;
- diagnosis of disease, injury or handicap;
- monitoring of disease, injury or handicap;
- treatment or alleviation of disease, injury or handicap;
- compensation for injury or handicap;
- investigation, replacement or modification of the anatomy or of a physiological process;
- control of conception
The updated guidance clarifies that the app must be linked to a specific disease, injury or handicap in order to fall within one of the medical purposes. This means that some of the more generic wellbeing and health monitoring apps are less likely to fall to be regulated as medical devices. The guidance seeks to provide clarification by setting out examples, including the following:
Apps may be classified as medical devices if they:
- aim to diagnose skin cancer from an image taken by the app;
- are designed to indicate the risk of a user developing a particular disease based on the information provided;
- monitor and collect patient information and the output is intended to affect the treatment of the patient;
- are designed to calculate the dose of insulin a diabetic needs to treat their diabetes based on carbohydrate in a meal;
- make recommendations to seek further advice based on the information provided by a user.
Apps are unlikely to amount to medical devices if they:
- record images of skin conditions which are then reviewed by a medical professional;
- are designed to indicate the risk of a specific group of the population developing a particular disease;
- monitor general health or fitness information (e.g. heart rate) or are intended to treat non-medical conditions (eg. non-specific stress);
- provide tips or advice on how to prevent a particular disease or make general recommendations to seek further advice;
- are designed to remind users to take their medication.
The medical purpose intended by the manufacturer or developer is relevant in assessing whether an app amounts to a medical device. App developers should therefore carefully review the description of what the app is intended to be used for in any promotional materials, labelling and instructions. It is important to note however that a general disclaimer will not be sufficient if the app does in fact qualify as a medical device.
Why does it matter if your app is a medical device?
If an app falls to be classified as a medical device it will be regulated by the MHRA and must comply with certain requirements before it can be placed on the market. The manufacturer will also have certain responsibilities once the app has been placed on the market, for example in monitoring and reporting adverse incidents.
In the UK, failure to comply with the relevant legislation relating to medical devices may result in a fine and/or imprisonment, as well as negative publicity and censure from the regulator.
Changes on the horizon
Certain changes are on the horizon which may impact the regulatory regime relevant to medical devices.
Firstly, the current legislation relating to medical devices is being revised. The new EU Medical Devices Regulation and EU In Vitro Diagnostics Regulation, replacing the current EU directives, are expected to be adopted this year and come into force over the following three to five year period.
Secondly, the UK voted in June to leave the EU. However, EU legislation continues to apply to the UK until the UK actually leaves, and therefore there is no impact on medical devices regulation in the short term. The longer term impact will become clearer once the terms of the UK’s post-exit relationship with the EU are known. In the event of a ‘soft Brexit’ businesses in the UK are likely to be required to comply with the majority of EU legislation. If there is a ‘hard Brexit’ the UK may adopt its own regime, however this may be similar to the EU regulatory framework. In any case, businesses will need to comply with EU legislation if they wish to trade in the EU.