Using apps in clinical practice guidance

This guidance was developed in April 2015 to provide clinicians and medical app developers with important information about the use of apps in clinical practice.

Key recommendations

  • You should not use medical apps, including web apps, that do not have a CE mark.
  • You should check that the actual version you are using has the CE mark.
  • If there is no CE mark,you must urgently ask the app’s developers to obtain one; meanwhile, you should stop using the app.
  • Always exercise professional judgement before relying on information from an app.
  • Always make sure that all the information you are using is for the right patient (some apps will keep data from the last time they are used).
  • If you know of any problems with apps used for medical purposes (such as calculation errors), please report these to the Medicines and Healthcare Products Regulatory Agency (MHRA)
  • If you develop an app that is intended for use in any medical context in Europe, it will need a CE mark, whether it is free to download or not.
  • Throughout the EU, including the UK, all medical devices and apps placed on the market must meet the requirements of the Medical Devices Directives and Regulations.
  • Class I devices require their manufacturer or UK representative to register with the MHRA and to self-certify compliance with a list of essential requirements.
  • Complex apps may additionally require the involvement of a notified body to assess them before the CE mark can be granted.