Medical Device (DM)
A medical device (MD) is an instrument, apparatus, equipment or software intended by its manufacturer to be used in humans for the purposes, in particular, of diagnosis, prevention, control, treatment, alleviation of disease or injury.
Getting started
A medical device is a product (tangible or intangible) that meets all of the following conditions:
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- It is used in human beings,
- For individual benefit (epidemiology tools, for example, are not concerned)
- For diagnostic or therapeutic purposes, for the compensation of a handicap or in the control of conception
- Whose mechanism of action is neither pharmacological, immunological nor metabolic
- And in the case of software, it createsnew medical information(storage, archiving, lossless compression, communication or simple search tools are not DM)
The field of medical devices is very vast: mobile application, cardiac implant or wheelchair, it's not the form that counts but the product's purpose of use.
Check out the full definition of a medical device here
Finding your way around technical doctrine
The technical doctrine presents the actions of the ministerial roadmap for the digital shift.
