Section 3: Classification of in vitro diagnostic medical devices.

In vitro diagnostic medical devices, other than in vitro diagnostic medical devices undergoing performance evaluation, are classified in two categories: 1° In vitro diagnostic medical devices whose reliability is a prerequisite for proper patient care and whose failures are likely to cause a serious health risk. These include in vitro diagnostic medical devices intended for self-diagnosis, as well as in vitro diagnostic medical devices, the list of which is established,…

In the event of disagreement on the application of the classification rules between the manufacturer of an in vitro diagnostic medical device and an authorised body involved in the conformity assessment procedures provided for in this Title, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall determine the certification procedure to which the device in question is subject.