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.
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.
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…
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,…
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…
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…
Failure to make the information provided for in I and II of article L. 5232-5 available to the public under the conditions defined in article R. 5232-20 is punishable by a fifth-class fine. Failure to comply with the time limit stipulated in article R. 5232-20 is punishable by a fifth-class fine.
Repeat offences under article R. 5232-21 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.
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is a Registered Trademark of
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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