What is the definition of a medical device?

Each regulatory body or regulation such as the FDA or the European Regulation (MDR) will have its own definition of a medical device which may differ slightly.

The WHO defines a medical device as follows:

‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • supporting or sustaining life,
  • control of conception,
  • disinfection of medical devices
  • providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

What does the Israeli medical device market look like?

The life science arena in Israel is on the rise. According to a survey made by AITI in 2017 there were approximately 1,350 active life science companies. The turnover of closing and opening of companies is also high since as many as 1,234 life sciences companies were established in Israel in the last decade (2007-2016). That means that approximately 123 companies were opened every year in average and 612 of them are still active.

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