French Public Health Code
In forceAs part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the in vitro diagnostic medical device with the essential requirements set out in Section 5 of this Chapter. He shall specify the principles for ensuring the quality of his production and guarantee that his manufacturing process complies with these principles.
The manufacturer shall establish and maintain a systematic procedure for reviewing the data acquired on in vitro diagnostic medical devices and shall apply the necessary corrective measures.
In addition, for a device intended for self-diagnosis, the manufacturer submits an application for examination of the design of this device to an authorised body, together with a dossier enabling the design of the device to be understood and its conformity with the essential requirements to be assessed. If the design of the device complies with the applicable provisions of this Title, 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 authorized body if it may call into question the conformity of the device with the essential requirements or the conditions of use of the device.
The manufacturer shall certify that the in vitro diagnostic medical devices comply with the provisions of this Title and the Orders made for its implementation which apply to them.
