French Public Health Code
In forceFor 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 system resulting from the concordant opinion of experts, or the specific procedures for this control by defining in particular:
1° The acceptability criteria met by the performance or characteristics of medical devices subject to internal or external quality control;
2° The nature of the inspection operations to be carried out to ensure that the performance of the medical devices is maintained and the procedures for carrying them out;
3° The frequency of inspections and situations requiring an inspection outside of periodic inspections;
4° The nature of maintenance operations on medical devices which require a new inspection outside the periodic inspections;
5° Recommendations for use and for bringing the devices back into compliance, taking into account any deterioration or inadequacy in performance or characteristics observed, as well as, where applicable, the time allowed for the operator to bring the devices back into compliance.
