Chapter II: Materials vigilance.

For the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, the list of which is set by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the operator is required to ensure that this performance and the maintenance of the medical device are maintained. This obligation gives rise,…

Certain medical devices for individual use appearing on a list drawn up by order of the ministers responsible for health and social security may be returned to a state of good repair with a view to re-use by patients other than those who initially used them. This return to good working order is subject to: 1° Compliance with criteria guaranteeing the quality and safety of use of the medical device…

The obligations of notification to the National Agency for the Safety of Medicines and Health Products or of information incumbent, under the vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the manufacturer or, where applicable, his authorised representative, the importer and the distributor, are defined by this Regulation, in particular in its…

For the devices mentioned in Article 1 of Regulation (EU) 2017/745, the list of which is set by order of the Minister responsible for health after receiving the opinion of the National Agency for the Safety of Medicines and Health Products, the health establishments mentioned in Article L. 6111-1 and the facilities mentioned in Article L. 6322-1 are required to fill in the registers created to monitor these devices. The…

For public health reasons, the Minister for Health, the Agence nationale de sécurité du médicament et des produits de santé and the Agence nationale de santé publique may access anonymous data relating to devices contained in the registers mentioned in article L. 5212-2-1.

A decree in the Council of State specifies the procedures for implementing the rules applicable to vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, as well as the organisational procedures of the authorities and bodies concerned.