Please login to the form below

Not currently logged in
Email:
Password:

Digital intelligence blog

Pharma insight on digital marketing, social media, mobile apps, online video, websites and interactive healthcare tools

Apps as medical devices - UK regulator updates its guidance

MHRA moves to help firms' health apps comply with its rules

Mersey Burns iPhone health appThe UK's regulator the MHRA has updated its guidance on whether a health app should be subject to medical device oversight.

A number of apps and pieces of stand-alone software that are already on the market have so far been classified as medical devices and consequently fall within the MHRA's remit.

They include those that gather data from a 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.

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.”

In the UK, as in the rest of Europe, software and apps that are defined as medical devices must gain a CE mark (kitemark) in line with the EU medical device directives to show they are 'regulated and acceptably safe to use and also perform in the way the manufacturer/ developer intends them to'.

The first health app to be classified as a medical device was the Mersey Burns app (pictured above), which was developed by doctors at the Mersey Regional Burns and Plastic Surgery Unit. Other apps that also have a CE mark include OncoAssist and Airstrip's patient monitoring apps.

The MHRA's new guidance on health apps as medical devices is available in an interactive pdf that developers through its processes.

Releasing the guidance the MHRA stressed that apps that give incorrect diagnoses or prescribe inappropriate treatments could have severe and potentially life-threatening consequences.

Wilkinson added: “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.”

26th August 2016

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
mXm Medical Communications

mXm Medical Communications meets the needs of pharmaceutical marketers and medics who require a highly experienced, bespoke service from their...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics