[3D printing in health care facilities: What legislation in France?].

Health care facilities more and more use 3D printing, including making their own medical devices (MDs). However, production and marketing of MDs are regulated. The goal of our work was to clarify what is the current French regulation that should be applied concerning the production of custom-made MDs produced by 3D printing in a health care facility. MDs consist of all devices used for diagnosis, prevention, or treatment of diseases in patients. Prototypes and anatomic models are not considered as MDs and no specific laws apply to them. Cutting guides, splints, osteosynthesis plates or prosthesis are MDs. In order to become a MD manufacturer in France, a health care facility has to follow the requirements of the 93/42/CEE directive. In addition, custom-made 3D-printed MDs must follow the annex VIII of the directive. This needs the writing of a declaration of conformity and the respect of the essential requirements (proving that a MD is secure and conform to what is expected), the procedure has to be qualified, a risk analysis and a control of the biocompatibility of the material have to be fulfilled. The documents proving that these rules have been respected have to be available. Becoming a regulatory manufacturer of MD in France is possible for a health care facility but the specifications have to be respected.