A medical device is « any instrument, apparatus, piece of equipment, material or product, with the exception of products of human origin, or other article used alone or in combination, together with any accessories and software used to make it operate, designed by the manufacturer to be used in people for medical purposes and whose main desired effect is not obtained by pharmacological or immunological means nor by metabolism, but whose function may be assisted by such means » (articles L 5211-1 R 5211-1 of the Public Health Code).

 

This definition corresponds to thousands of products that are extremely diverse on account of their weight, size and production cost, but all fulfil the same objectives: to prevent, diagnose, control, alleviate, ..., an injury, disease or handicap.

 

Examples: syringe, scanner, implantable prosthesis, operating theatre equipment, software for the remote monitoring and transmission of patient data.