Title II: In vitro diagnostic medical devices

The CE marking may be affixed to an in vitro diagnostic medical device only if it complies with the essential requirements and has undergone the assessment procedures applicable to it. Where an in vitro diagnostic medical device is also governed by other provisions requiring the affixing of a CE marking, the marking shall indicate that the device also complies with those provisions. If these provisions allow the manufacturer, during a…

The CE marking is affixed under the responsibility of the manufacturer or his authorised representative, in a visible, legible and indelible manner on the in vitro diagnostic medical device where this is possible and appropriate, as well as on the commercial packaging and on the instructions for use. The form and dimensions of this marking are set by order of the Minister for Health. The CE marking is accompanied, where…

The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided that they are not used on samples from participants and that a visible sign clearly indicates that these devices may not be placed on the market or put into service until they have been brought into compliance.

The provisions of articles R. 5211-15, R. 5211-17, R. 5211-19 and R. 5211-20 are applicable to in vitro diagnostic medical devices.