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What is a medical device?
The umbrella term 'medical device' includes medicines, implants and medical imaging. They are usually used inside the body, but can also provide information about health status outside (in vitro) the body, for example a biopsy.
There are four classes of medical devices based on how invasive they are to the body.
- Class I: non-invasive, does not invade the body, external use only.
- Class IIa: minimally invasive, disrupts the normal functioning of the body as little as possible.
- Class IIb: invasive, penetrates the body and has a certain effect there.
- Class III: highly invasive, agents placed in the body for long term.
Every medical device undergoes evaluations around safety, quality and function before being marketed as such. Manufacturing takes into account large-scale clinical studies and quality standards.
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