Section 2: Vigilance of the health products mentioned in 18° and 19° of Article L. 5311-1

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,…