Medical Devices
A medical device (MD) is an instrument, apparatus, equipment or software intended by its manufacturer to be used in humans for purposes such as diagnosis, prevention, control, treatment, mitigation of disease or injury.
Getting started
A medical device is a product (physical or not) that meets all of the following conditions:
- It is used in humans,
- For individual benefit (epidemiology tools, for example, are not included)
- For diagnostic or therapeutic purposes, to compensate for a disability or for contraception
- Whose mechanism of action is neither pharmacological, immunological nor metabolic
- And in the case of software, it creates new medical information (tools for storage, archiving, lossless compression, communication or simple research are not MDs)
The field of medical devices is very vast: Whether it’s a mobile app, a cardiac implant or a wheelchair, the purpose of the product rather than the form is what matters.
Finding your way around the technical framework
The technical framework describes the actions in the ministerial roadmap for the eHealth shift.
