French Public Health Code
In forceAs part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examination certificate.
The manufacturer must take all measures necessary to ensure that the manufacturing process guarantees conformity of the in vitro diagnostic 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. It shall draw up technical documentation relating to the manufacture of in vitro diagnostic medical devices.
The manufacturer 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 authorised body referred to by the manufacturer carries out the necessary examinations and tests in order to verify 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. In the latter case, if the procedure for checking the devices manufactured is not suitable for certain aspects, the manufacturer must, with the agreement of the approved body, establish methods for testing, monitoring and checking during manufacture. The manufacturer must provide the authorized body with the relevant information to ensure compliance with the obligations attached to these testing, monitoring and inspection methods and authorize the authorized 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 approved 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 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 the Orders made for its application which are applicable to them.
