GP health apps should be registered as devices

GPs who create their own health apps should register them as health devices, according to a charity that promotes health technology.

The charity d4 has released a report which aims to guide manufacturers and users on the new technology.  

Around 1,000 health apps come on to the market every month and they may be subject to European laws, which are defined under the Medical Device Directive.

Any GP creating health apps for the market would be legally responsible for making sure they comply with EU legislation, even if the apps are available free.

The report recommends that anyone unsure whether their app qualifies as a medical device should err on the side of caution and have it registered.

The cost of registering an app as a medical device starts at £70. One of the benefits of registering an app is that it will carry the CE label, which confirms to customers that it complies with European regulations.

According to the Medicines and Healthcare products Regulatory Agency (MHRA),  an app can be classed as a medical device if it carries out complex calculations in place of a clinician.

This means that a simple BMI calculator may not be classed as a medical device, but a paediatric dosage calculator which recommends dosage according to a patient’s data would.

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