[Testing of medical devices (author's transl)].

The French regulation of medical devices is already old. it gradually begins since 1940 firstly for the need of safety in radiology. In 1952, an Interministerial Commission (Health, Welfare, Defense, Interior, etc.) was instituted for the medical devices approval: the anaesthesiological devices were examinated since 1956. But this regulation is weak because there is no effective penalty. Nevertheless it is efficient: it had allowed the collection of important documents especially in the fields of radiology, anaesthesiology and intensive care, and recently in hemodialysis. During the last ten years all medical devices in this fields were examinated by the French essay laboratories and their performances were registraded. If the compliance of a device is not effective the approval is not gived. For anaesthesiological and intensive care devices, the approval is give, after clinical testing, only for five years. This approval is not renewed if there are complaints about the device during this time. But medical devices are not easy to define and to test. The best definition seems the American one: "There is a new definition of "device". In broad terms, a device is a health-care product that does not achieve any of its principal intended purposes by chemical action within or on the body or by being metabolized. There is specific recognition that a device may diagnose "conditions" that are not necessarily "diseases" (Medical device Amendment, 1976)." The french regulation is of course not perfect: we suffer of a lack of a law on medical device thus this regulation is appliable only if the public health is envolved. Nevertheless a rather good protection of the patients is assured and the efficiency is gradually better as the international exchanges give technical and clinical informations.