What constitutes a sub-assembly?
Guidance from the Commission has clarified the definition, and items which are designed, manufactured and intended to form part of an item of apparatus do not have to comply with the directive (only the finished product must so do). If, however, the item would perform a direct function for an end user, and is placed on the market, then it is covered by the requirements of the directive. A direct function is defined by the Commission as “any function of a component or a finished product which fulfils the intended use specified by the manufacturer in the instructions for use for an end user.
