Subsection 9: EC declaration of conformity, product quality assurance.

As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessment of the quality system relating to the final inspection and the associated tests. This application must include technical documentation setting out all the requirements and provisions adopted by the manufacturer for his quality system.

The manufacturer undertakes to keep his quality system for final inspection and associated tests appropriate and effective and to fulfil the obligations arising from it. In the case of medical devices placed on the market in a sterile state, the manufacturer also undertakes to maintain an appropriate and effective quality system for obtaining and maintaining this state and to fulfil the obligations arising from this 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 shall carry out an assessment of the quality system relating to the final inspection of medical devices and the tests relating thereto. This assessment includes an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of suppliers or subcontractors to control 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.

The manufacturer shall ensure the application of the quality system for final inspection as approved and, where appropriate, the application of the quality system for obtaining and maintaining sterility of medical devices.

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 has approved the quality system relating to the final inspection of any plans for major changes to this system. The authorized 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 shall notify the manufacturer of its decision.

The provisions of the preceding paragraph also apply to the quality system for obtaining and maintaining sterility.

The manufacturer must provide the approved body with the information necessary to ensure that the obligations associated with its quality system are fulfilled and authorise the approved body to carry out all necessary inspections. The approved body shall 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.

The provisions of the previous paragraph also apply to the quality system for obtaining and maintaining sterile status.