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Article D5232-11 of the French Public Health Code

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.

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Article D5232-12 of the French Public Health Code

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.

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Article D5232-13 of the French Public Health Code

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…

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Article D5232-14 of the French Public Health Code

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,…

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Article D5232-15 of the French Public Health Code

In the event that the service provider or equipment distributor is unable to provide the equipment or service adapted to the person who is ill or has an incapacity or disability, they will immediately inform the person or their family and friends, if applicable, and inform them that they are free to use another service provider or distributor likely to meet their expectations.

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Article R5232-16 of the French Public Health Code

The purpose of the vigilance exercised over the software mentioned in 18° of Article L. 5311-1 and the devices mentioned in 19° of the same article, used in medical biology laboratories, is to monitor the incidents defined in 1° of Article R. 5232-17. Vigilance is carried out on all the health products mentioned in the first paragraph after they have been placed on the market.

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Article R5232-17 of the French Public Health Code

Vigilance includes: 1° For user healthcare professionals mentioned in Article L. 5232-4, the reporting to the Agence française de sécurité sanitaire des produits de santé of any incident consisting of a failure or alteration in the characteristics or performance of the health products mentioned in this section, or an inadequacy in the labelling or instructions for use, likely to result in adverse effects on the health of individuals; 2° For…

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Article R5232-18 of the French Public Health Code

When informed of an incident, the Director General of the Agence française de sécurité sanitaire des produits de santé will arrange for it to be assessed. As part of this assessment, he will carry out any investigation necessary to ensure vigilance. Manufacturers, publishers, distributors and users of software and hardware shall, at the request of the Director General, provide any information he may require in the performance of his duties,…

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Article R5232-19 of the French Public Health Code

For the purposes of this section, foodstuffs as defined in Article 2 of Regulation (EC) No 178/2002 and substances, mixtures and articles as defined in Article 3 of Regulation (EU) No 1907/2006, with the exception of medicinal products, are considered to be products within the meaning of Article L. 5232-5. A joint order by the Ministers for Health and the Environment, on a proposal from the Agence nationale de sécurité…

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Article R5232-20 of the French Public Health Code

The information provided for in I and II of Article L. 5232-5 shall be made available in a dematerialised format, accessible free of charge and reusable in such a way as to allow aggregation. To this end, any person who places products on the market within the meaning of Article L. 5232-5 shall make the information available either on a dedicated website or webpage, or by means of an application…

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