As part of the EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an application to the authorised body for assessment of this quality system, which includes technical documentation setting out all the requirements and provisions adopted by the manufacturer for his quality system, particularly, where applicable, with regard to sterilisation.
The manufacturer undertakes to maintain his quality system in an appropriate and efficient manner and to fulfil 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.
The manufacturer ensures that the quality system as approved is applied and carries out the final inspection of the medical devices.
In addition, on completion of the manufacture of each batch of devices incorporating, as an integral part, a substance which, if used separately, may be considered to be a blood-derived medicinal product, the manufacturer must 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.
The manufacturer certifies that the medical devices manufactured conform to the type described in the EC type-examination certificate and comply with the provisions of this title and the orders issued for its application which are applicable to them. This certificate covers one or more manufactured devices, identified by means of the name of the product, the product code or another unambiguous reference.
It informs the approved body which approved the quality system of any plans for major changes to this system. The approved body shall verify that the system thus modified ensures conformity of the medical devices manufactured with the type described in the EC type-examination certificate. The approved body notifies the manufacturer of its decision.
The manufacturer must provide the authorized body with all relevant information to ensure that the obligations arising from his quality system are fulfilled and authorize the authorized 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.
