Book II: Medical devices, in vitro diagnostic medical devices and other products and articles regulated in the interests of public health

The service provider and the equipment distributor provide a comprehensive service comprising all the elements defined by order of the Minister for Health. Depending on the category of equipment, its importance in terms of the autonomy of the person who is ill, incapacitated or disabled, or the need to guarantee continuity of treatment, in the event of repairs requiring equipment to be immobilised for more than one day, the service…

Where they exist, the service provider and equipment distributor comply with the equipment prescription and recommendation issued by the multidisciplinary team under the conditions provided for in article L. 146-8 of the Code de l’aide sociale et de la famille. Within a timeframe compatible with the treatment or autonomy needs of the person who is ill, incapacitated or disabled, they provide the most appropriate equipment and services.

The service provider and equipment distributor apply the advice on use and safety given by the equipment manufacturer. They provide the person who is ill or has an incapacity or disability and their family and friends with all the information and explanations relating to the service and the equipment supplied, in accordance with the conditions defined by order of the Minister for Health.

In order to carry out their activities, service providers and equipment distributors have premises reserved for this purpose, including at least one area meeting accessibility requirements for disabled people in accordance with the provisions of article L. 164-1 of the French Construction and Housing Code and the regulations governing 5th category establishments open to the public. This area is reserved for the personalised reception of the patient, including any tests…

In order to provide the most appropriate equipment for the needs of the person who is ill or has an incapacity or disability, the service provider and the equipment distributor will ask the prescriber or the multidisciplinary team responsible for drawing up a personalised compensation plan for any additional information they deem necessary, particularly when they feel they have insufficient information on the development of the person’s pathology. Where appropriate,…