Section 10: Systems and components intended to be assembled to form a medical device.

A natural or legal person who assembles devices bearing the CE marking, in accordance with their intended purpose and within the limits of use laid down by their manufacturers, in order to place them on the market in the form of a system or kit, shall draw up a declaration in which he certifies: 1° it has checked the mutual compatibility of the devices in accordance with the manufacturers’ instructions…

If a system or kit does not meet the conditions set out in Article R. 5211-67, and in particular if it contains devices not bearing the CE marking or if the compatibility of the assembled devices is not apparent from their manufacturers’ instructions, it is considered to be a device in its own right subject to the certification procedures.

The systems and kits are accompanied by the information mentioned in Article R. 5211-22, including, where applicable, the information supplied by the manufacturers of the devices that have been assembled. They do not have to carry an additional CE marking.