Described as a health and safety measure, the Directive aims to ensure harmonised standards and reduce barriers to trade. There are specific measures for the control of ergonomic hazards, noise, vibration and radiation.
Evidence from:
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006
Many of these requirements are to reduce risks to the lowest level, or to the minimum possible. Biological change such as fatigue, are defined as adverse outcomes. The Directive could be related to health and safety at work, but it is so open-ended as to be unhelpful to the machine manufacturer.
Further detail: