Book II: Medical devices, in vitro diagnostic medical devices and other products and articles regulated in the interests of public health

Without prejudice to the provisions of Article R. 5221-9, in vitro diagnostic medical devices which comply with the standards relating to them and transposing the harmonised European standards, the references of which have been published in the Journal officiel de la République française, are presumed to comply with the essential requirements defined in Section 5 of this chapter.

In vitro diagnostic medical devices appearing on the list established by the order referred to in Article R. 5221-6, designed and manufactured in accordance with common technical specifications published in the Official Journal of the European Union and establishing performance assessment and reassessment criteria, batch release criteria, reference methods and materials, are, within the scope of these specifications, presumed to comply with the essential requirements. Manufacturers are required to comply…

All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or for the devices referred to in Article L. 5221-5.

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.