Section 3: Classification of medical devices

For the purposes of this Title, medical devices other than active implantable medical devices are divided into four classes known as Class I, Class IIa, Class IIb and Class III. Whether a device belongs to one or other of these classes is determined in accordance with the classification rules defined, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé,…

If a medical device is intended to be used in conjunction with another medical device, the classification rules apply separately to each device. Computer software controlling a device or influencing its use comes under the same class.

For the purposes of this Title, accessories to medical devices are treated as devices in their own right. Accessories are classified as such, independently of the devices with which they are used, with the exception of accessories for active implantable devices treated as active implantable devices.

Where a medical device is not intended for use in a specific part of the body, it must be considered and classified according to the most critical use as specified. Where more than one rule applies to the same device because of the uses indicated by the manufacturer, the rule which applies shall be the most stringent and the device shall be classified in the highest class.

In the event of a dispute over the application of the classification rules between the manufacturer of a device and an authorised body involved in the certification 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 class to which the device in question belongs.