That is true as long as the equipment is used in accordance with the instructions and as intended by the equipment manufacturer.  The oxygen concentrator manufacturer will stipulate in their Instructions for Use that you ‘fit a firebreak’, not doing so means that the Essential Requirements for performance and safety of the Medical Device Directive are not met and the CE mark is no longer valid.

You must follow the manufacturer’s instructions when installing the oxygen concentrator and fit a firebreak.

The regulations make clear that a distributor modifying a product to the extent that compliance with the Essential Requirements becomes affected, becomes the manufacturer.

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