As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer must submit to an authorized body for verification the manufacturing quality system which he has set up to ensure conformity of the in vitro diagnostic medical devices with the approved type described in an EC type-examination certificate.
The manufacturer submits an application to the approved 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.
The manufacturer undertakes to maintain an appropriate and efficient quality system and to fulfil the obligations arising from it. The manufacturer also undertakes to implement and keep up to date a systematic procedure for examining the data acquired on in vitro diagnostic medical devices and to apply the necessary corrective measures.
The assessment by the approved 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 in vitro diagnostic medical devices included on list A of the order mentioned in article R. 5221-6, a production inspection is carried out by the authorised body. To this end, the manufacturer sends the body the documents required for quality control of the devices or batches of devices manufactured and provides it with a sample of devices or batches of devices manufactured under mutually agreed conditions. On expiry of a contractually agreed period, which may not exceed thirty days from receipt of the sample by the approved body, the manufacturer may place these devices or batches of devices on the market if the approved body has not notified him of a decision to the contrary.
The manufacturer shall ensure that the quality system as approved is applied and shall carry out the final inspection of the in vitro diagnostic medical devices.
The manufacturer shall certify that the in vitro diagnostic medical devices manufactured conform to the type described in the EC type-examination certificate and comply with the provisions of this Title and of the Orders made for its application which are applicable to them.
It shall inform the authorized 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 in vitro diagnostic 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 the information necessary 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.
