French Public Health Code
In forceAs part of the procedure for the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up for the design, manufacture and final inspection of the medical devices and the application of which must guarantee compliance with the provisions of this Title and the implementing orders which apply to them.
The manufacturer submits an application for assessment of this quality system to an approved body and undertakes to maintain its quality system in an appropriate and efficient manner and to comply with the obligations arising from it. The manufacturer also undertakes to set up and keep up to date a systematic procedure for examining the data acquired on medical devices and to apply the necessary corrective measures.
The assessment by the authorized body of the quality system includes an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of suppliers or subcontractors to check the manufacturing processes. The decision of the approved body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessment.
In addition, for a class III medical device or an active implantable medical device, the manufacturer must submit an application for examination of the design of this device to the authorized body, together with a dossier enabling the design of this device to be understood and its conformity with the essential requirements defined in section 5 of this chapter to be assessed. For the purposes of assessing such conformity, the authorized body may require the application to be supplemented by additional tests or evidence. If the design of the device complies with the essential requirements, the authorized body shall issue an EC design examination certificate.
As part of the examination of the design of a device which incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product, with the exception of medicinal products derived from blood, and which may act upon the human body by means of an action ancillary to that of the device, the authorised body obtains the opinion of the Agence nationale de sécurité du médicament et des produits de santé, one of the competent authorities for medicinal products designated by the other Member States or parties to the Agreement on the European Economic Area or the European Medicines Agency before taking a decision. This opinion is included in the documentation concerning the device. The authorised body shall inform the authority consulted of its decision. Where the national competent authority consulted is the Agence nationale de sécurité du médicament et des produits de santé, its opinion shall be given within a maximum period of two hundred and ten days from receipt of complete documentation.
When examining the design of a device which incorporates, as an integral part, a substance which, if used separately, could be considered to be a medicinal product derived from blood, and which may act on the human body by means of an action ancillary to that of the device, the authorised body shall obtain the scientific opinion of the European Medicines Agency. This opinion is included in the documentation concerning the device. If the opinion of the European Medicines Agency is unfavourable, the authorised body may not issue the certificate. It shall inform the European Agency of its decision.
The manufacturer must inform the authorized body which issued the certificate of any subsequent changes made to the design of the device. This modification must be approved by the authorized body if it may call into question the conformity of the device with the essential requirements or the conditions of use of the device.
The manufacturer shall ensure that the quality system as approved is applied and shall certify that the medical devices conform to the provisions of this Title and of the Orders adopted for its implementation which are applicable to them. This certificate covers one or more manufactured devices, identified by means of the product name, the product code or another unambiguous reference.
In addition, on completion of the manufacture of each batch of devices incorporating, as an integral part, a substance which, if used separately, is liable to be considered as a blood-derived medicinal product, the manufacturer shall inform the authorised body of the release of this batch of devices and send it the batch release certificate for the substance referred to in Article R. 5212-24 used in this device, drawn up by the Agence nationale de sécurité du médicament et des produits de santé, or a laboratory designated for this purpose by another Member State of the European Union or party to the Agreement on the European Economic Area.
It informs the accredited body which approved this system of any major modification planned. The approved body shall check that the modified system ensures compliance with the provisions of this Title.
The manufacturer must provide the approved body with all relevant information to ensure that the obligations arising out of his quality system are fulfilled and authorise the approved body to carry out all necessary inspections. The approved body must periodically carry out appropriate inspections and assessments and may, during unannounced visits, carry out tests or have tests carried out to check the operation of the quality system.
