So when is an app a medical device?
The first question to ask is ‘does my app fall under the definition of a medical device i.e. does it have a medical purpose?’ To that end, you need to review the relevant definition, as per the European Medical Device Directive 93/42/EC definition: ‘Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
- decision making software that provides a calculation, decision support algorithm e.g. dose calculation which will aid a clinician are likely to fall within the scope of the medical device directive,
- apps which are accessories to medical devices e.g. measurement of blood pressure, heart rate
- software which collects information entered by the User, measured by the app or collected by a point of care device where the output is likely to affect treatment decisions
- software used to book appointments, request a prescription or have a virtual consultation
- software that provides general disease information
- decision support software which provides information to a clinician but where the clinician ultimately relies on their own professional judgement
- Medical device stand-alone software including apps. MHRA Guidance, 8 August 2014
- Classification of medical devices, MEDDEV 2.4/1 rev. 9, June 2010