The first attempt to produce regulations for medical implants in France was made in the field of orthopaedics. In 1984, due to a constant increase in the development and marketing of innovative devices, a task force was created in the French Ministry for Health and Social Affairs to study and propose protocols for the market approval of total hip prostheses. This decision was made in response to an increased market release of new devices and materials without proof of reliability and safety.
The task force included orthopaedic surgeons, manufacturers, engineers, and government representatives. After three years of working together, a consensus was established among the different parties, and market approval of total hip prostheses by the French ministry for Health and Social Affairs became mandatory on October 1, 1987. However, a two-to threeyear grace period was granted before regulation should apply to those prostheses that had been implanted before March 31, 1988. During this period, those prostheses can still be used without market approval provided an approved application has been filed. Beyond that period, all hip prostheses must be approved for marketing to the Public Health Service. The regulation will soon after be extended to the private sector.