French Public Health Code
In forceI.-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 inventory available to the agents mentioned in article L. 1333-29 and article L. 5412-1 ;
2° To define and implement an organisation designed to ensure that the maintenance and internal or external quality control of the devices are carried out, the details of which it specifies and which are transcribed in a document; in the health establishments mentioned in Article R. 5212-12, this organisation is adopted after consulting the medical advisory bodies; in the health cooperation groupings mentioned in article R. 5212-12, this organisation is defined by the grouping's constitutive agreement; users are informed of this organisation; changes to this organisation result in the document being updated without delay;
3° To have at its disposal information enabling it to assess the measures adopted for the organisation of maintenance and internal or external quality control, as well as the procedures for carrying them out;
4° To carry out the checks provided for in Articles R. 5212-27 and R. 5212-27-1 ;
5° Keeping an up-to-date register for each medical device, in which all maintenance and internal or external quality control operations are recorded, with the identity of the person who carried them out and, where applicable, their employer, the date on which the operations were carried out and, where applicable, the date of cessation and resumption of operation in the event of non-compliance, the nature of these operations, the level of performance obtained and the result concerning the conformity of the medical device; this register is kept for five years after the end of operation of the device, except in the case of special provisions laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé for certain categories of device;
6° To allow access to medical devices and the information provided for in this article to any person in charge of maintenance and quality control operations.
II.-For the medical devices mentioned in Article R. 5212-27-1, the operator must ensure that :
1° An acceptance test carried out by the manufacturer or under his responsibility before the first use for medical purposes ;
2° an internal quality control carried out at intervals set in accordance with the quality control procedures defined by the manufacturer or the Director General of the Agence nationale de sécurité du médicament et des produits de santé as provided for in Article R. 5212-27-1 and after each service likely to have an effect on the operation of the device.
