Section 2: Definitions.

For the purposes of this Title, the following definitions shall apply 1° Accessory means any article which is intended by its manufacturer to be used principally with an in vitro diagnostic medical device in order to enable the latter to be used in accordance with its intended purpose, with the exception of invasive medical devices intended for taking samples and medical devices placed in direct contact with the human body…

The definitions given in 1°, 3°, 4° and 5° of Article R. 5211-4 are applicable to in vitro diagnostic medical devices.