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.
