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1.1 General presentation and definition

L’ ANSM defines a medical device (MD) as "an instrument, apparatus, equipment or software intended by its manufacturer for use in humans for such purposes as diagnosis, prevention, control, treatment, mitigation of disease or injury" . In this study, we will use either "medical devices" or "medical devices" to refer to these products.

The schematic above, presented by Qualitiso, exhaustively summarizes the definition of a DM according to the European Directive 93/42/EEC.

The market for medical devices is strictly controlled by European and French regulations. The various products are divided into 4 classes according to their level of dangerousness (level of potential risks taking into account the vulnerability of the human body):

  • Class I: low risk;
  • Class II-a : medium risks ;
  • Class II-b: high risk;
  • Class III: critical risks.

DMs are a heterogeneous category e grouping a multitude of products ( between 800,000 and 2,000,000,000 of references in France according to HAS Health ). The different products can therefore be segmented according to their use as follows ( Financière d'Uzès ) :

  • DM for individual use (hospital equipment, anaesthetic and respiratory devices, etc.);
  • Equipment (non-active implants, dental equipment...) ;
  • In vitro diagnosis (pregnancy tests, glucose meters...) ;
  • E-Health (Real-time monitoring of physiological parameters at home).

As for the rental of medical equipment It is offered to health care institutions by specialized companies. In France, clients are therefore generally public structures (or semi-public) and must therefore go through calls for tenders to rent equipment. By browsing the site The Central Market Office which lists calls for tenders, we observe the different types of clients for the rental of medical equipment: hospitals, clinics, nursing homes, offices of nurses, social action centres, etc.

The main types of equipment rented to health facilities are thus "durable" equipment (hospital beds, patient lifts, wheelchairs, respiratory assistance equipment, etc.), electronic diagnostic equipment, equipment for home consultations, as well as surgical equipment.

Source : Transparency Market Research - Businesscoot processing







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