In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees conformity of the medical devices manufactured with the type described in the EC type-examination certificate and with the essential requirements defined in Section 5 of this Chapter which apply to them. He shall draw up technical documentation relating to the manufacture of medical devices.
In the case of medical devices placed on the market in a sterile condition, the manufacturer must also undertake to keep the quality system set up to obtain and maintain this condition suitable and effective and to fulfil the obligations arising from the quality system.
The manufacturer undertakes to implement and keep up to date a systematic procedure for examining the data acquired on medical devices and, where appropriate, on aspects relating to sterilisation and to apply the necessary corrective measures.
In the case of medical devices placed on the market in a sterile state, the authorised body carries out an assessment of the quality system for obtaining and maintaining the sterile state. This assessment includes an inspection on the manufacturer’s premises and, in duly justified cases, on the premises of suppliers or subcontractors to check the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessment.
In all cases, the approved body to which the manufacturer has recourse carries out the necessary examinations and tests to check the conformity of the devices with the type described and the essential requirements. This verification is carried out, at the manufacturer’s choice, either by inspection and testing of each product, or by inspection and testing of the products on a statistical basis. It does not concern sterilisation-related elements.
In addition, for medical devices other than active implantable medical devices where verification is carried out by inspection and testing of each product, and for all medical devices, including active implantable medical devices, where verification is carried out on a statistical basis, the manufacturer must inform the authorised body, in the case of medical devices incorporating as an integral part a substance which, if used separately, is likely to be considered as a blood-derived medicinal product, of the release of each 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 authorised body affixes or causes to be affixed its identification number to each product and draws up a certificate of conformity relating to the tests carried out.
The manufacturer shall certify 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.
Where appropriate, the manufacturer must provide the authorized body with the relevant information to ensure compliance with the obligations associated with his quality system for obtaining and maintaining sterile status and authorize the authorized body to carry out all necessary inspections. The approved body will periodically carry out appropriate inspections and assessments and may, during unannounced visits, carry out tests or have tests carried out to verify the operation of the quality system.
