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 testing of in vitro diagnostic 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 authorised body and undertakes to maintain its quality system appropriate and effective 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 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 a device included in list A of the order referred to in article
R. 5221-6, the manufacturer submits an application for examination of the design of this device to the authorised body, enclosing a file 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. The manufacturer must inform the authorized body which issued the certificate of any subsequent modification made to the design of the device. This modification must be approved by the authorised body if it may call into question the conformity of the device with the essential requirements or the conditions of use of the device.
For in vitro diagnostic medical devices included in list A of the order mentioned in article R. 5221-6, a production control is carried out by the approved body. To this end, the manufacturer sends the body the documents required for quality control of the devices or batches of devices manufactured and makes available to it, under mutually agreed conditions, a sample of devices or batches of devices manufactured. On expiry of a contractually agreed period which may not exceed thirty days from receipt of the sample by the authorised body, the manufacturer may place these devices or batches of devices on the market if the authorised 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 certify that the in vitro diagnostic medical devices comply with the provisions of this Title and the implementing orders applicable to them. It informs the authorised body which approved this system of any plans for major changes. The approved body checks that the modified system ensures compliance with the provisions of this Title.
As soon as the manufacturer is aware of changes in the pathogens or markers of infection to be tested, he must inform the approved body without delay and state whether these changes are likely to affect the operation of the device.
The manufacturer must provide the authorised body with the information necessary to ensure that the obligations arising from his quality system are fulfilled and must authorise the authorised body to carry out all necessary inspections. The authorized body must periodically carry out appropriate inspections and assessments and may, during unannounced visits, carry out tests or have them carried out in order to verify the functioning of the quality system.
