Chapter II: Materials vigilance

For the devices mentioned in Article R. 5212-26, with the exception of those used during exposure to ionising radiation, subject to internal or external quality control, the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall set by decision published on the Agency’s website, depending on the devices, either the applicable reference…

For the medical devices mentioned in Article R. 5212-26 and used during exposure to ionising radiation : 1° Manufacturers shall provide operators with the internal quality control procedures for their devices; 2° The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by decision published on the Agency’s website, lay down, depending on the devices, either the applicable reference system resulting from the…

I.-For the medical devices mentioned in article R. 5212-26, the operator is required : 1° Keep a regularly updated inventory of the devices it operates, mentioning for each of them the common and commercial names of the device, the name of its manufacturer and that of the supplier, the serial number of the device, its location and the date on which it was first put into service, and make this…

I.-External quality control of medical devices is carried out by bodies accredited for this purpose by the Comité français d’accréditation or by any other accreditation body which is a signatory to a multilateral recognition agreement concluded within the framework of the European coordination of accreditation bodies. An order of the Minister for Health, issued after obtaining the opinion of the Director General of the Agence nationale de sécurité du médicament…

At the operator’s request, the accredited bodies carry out the inspections in accordance with the specific provisions set out in Articles R. 5212-27 and R. 5212-27-1. Each external quality control gives rise to a report on the maintenance of the performance of the device inspected. This report mentions the name of the operator, the device inspected, the nature of the checks carried out and any non-conformities observed. It is given…

If a quality control reveals a deterioration in the performance or characteristics of the device, the operator shall take appropriate measures relating to its use and shall bring the device back into compliance in accordance with the provisions of articles R. 5212-27 and R. 5212-27-1 . If the deterioration in performance observed is likely to lead to a risk of an incident as provided for in article L. 5212-2, this…

In the case of external quality control, the return to conformity of the devices is certified by the compliant results of a second quality control carried out on the device in accordance with the provisions of Article R. 5212-30. If, after this second inspection, the expected performance of the device is still not achieved, the accredited body shall inform the Director General of the Agence nationale de sécurité du médicament…

If the quality control has led to the reporting of a risk of incident as provided for in Article R. 5212-31, the operator shall notify the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the regional health agency within whose jurisdiction the operator is established, of the medical device’s return to compliance or its definitive withdrawal from service….

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may give formal notice to any operator of a medical device subject to the quality control provided for in this Title to have it carried out.