Press release

Is your App a medical device? It’s healthy to know: regulator issues updated guidance

Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe.

Is your app a medical device

From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and stand-alone software are a part of everyday life. You might not realise depending on an unregulated app to provide a diagnosis or recommend treatment could have potentially life-threatening consequences.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance today to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe.

The guidance is presented as a step-by-step interactive PDF. App users can use this guidance to check if their health app is a medical device, and what to look for to make sure the app is safe and works.

Software and app developers can use the guidance to identify if their product is a medical device. It will aid developers in navigating the regulatory system so they are aware what procedures they need to have in place to get a CE mark which indicates acceptable safety standards and performance, and what their reporting responsibilities are when things change or go wrong.

Many apps and pieces of stand-alone software currently on the market are classified as medical devices. These are apps which gather data from the person or a diagnostic device, such as diet, heartbeat, or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine, or recommend treatment.

It is important that apps which are medical devices comply with medical device regulation and work as expected. Apps that give incorrect diagnoses or prescribe inappropriate treatments may have severe, potentially life-threatening consequences.

John Wilkinson, MHRA’s Director of Medical Devices said:

We live in an increasingly digital world, both healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health.

Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.

Patient safety is our priority. We continue to encourage people to report any safety or performance issues involving medical devices, including apps, to MHRA via our Yellow Card Scheme online.

View the updated guidance.

Background

  1. The term medical device is used to cover all devices under regulation i.e. medical devices, active implantable medical devices, such as cochlear implants, and in vitro diagnostic medical devices, such as blood glucose meters.
  2. The Yellow Card Scheme is the UK system for collecting and monitoring information on suspected adverse drug reactions (ADRs) and adverse incidents with medical devices. This is available online
  3. Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.

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Published 25 August 2016