The MDR defines a medical device as follows:
Any instrument, apparatus, appliance, software, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
Software incorporated into a product falls in above definition e.g. app registering blood glucose levels, measured by a Bluetooth connected glucometer. Wearables or mobile apps that transfer measurement data from the human body such as temperature, weight, pulse, etc. are considered a medical device, irrespectively if the data has been entered by a sensor with body contact, an implant or manually. Software connected to the wearable is determined by the same classification as the wearable.
Software in its own right (standalone) that falls in above definition is also a medical device. E.g. an app to determine melanoma or not via capture of an image.
Software that is an accessory to a medical device is also treated as a medical device in its own right. An accessory is defined as
Software which, whilst not being itself a medical device, is intended to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).
The qualification of software, either as a medical device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.
Software for general purposes, even when used in a healthcare setting and software intended for life-style and well-being purposes is not a medical device.
Examples:
- Data in databases, registers and forms
- Digital transmission of manual counselling services
- Collect and maintain administrative patient details
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