Regulation 14

no trade description which is false or misleading, or which explicitly or implicitly suggests that the supply or use of the medical device is promoted or endorsed by the Authority, shall be applied to the medical device; and

no change or modification made, or caused to be made, to the presentation of the medical device, for the purpose of promoting or demonstrating the use of the medical device, shall cause the medical device to depart from its product owner’s specifications in relation to its intended purpose, design, components and method of installation or operation.

a trade description is false or misleading, if it —

contains any false statement or information concerning the medical device; or

is likely to create an erroneous impression regarding the formulation, composition, design specification, quality, safety, efficacy or uses of the medical device; and

a person applies a trade description to a medical device, if he —

affixes or annexes the trade description to, or in any manner marks it on or incorporates it in —

the medical device; or

any thing in or on the medical device or with which the medical device is supplied;

places the medical device in, on or with any thing which the trade description has been affixed or annexed to, marked on or incorporated in; or

makes any oral or written statement of the trade description, or uses the trade description in any other manner, which is likely to be understood as referring to the medical device.