Machinery Directive (2006/42/EC)
Machinery is in EU/EEA regulated by the machinery directive, often referred to as MD, which defines the basic safety requirements for machinery to be placed on the European market. When machinery manufacturers place CE marking on their product, they are stating that the product complies with all applicable directives. To affix CE marking to a product, manufacturers must issue a Declaration of Conformity (DOC). This is a formal signed statement indicating conformity of the referenced product to the listed provisions of the applicable directive(s) and standards. Most machine manufacturers (about 95 percent) can self-certify their compliance with the Machinery Directive (i.e., it is not mandatory to use an outside agency in most cases). A few product categories, including high-risk machinery such as saws, etc., require third-party certification what we call a Notified Body.
The Machinery manufacturer must apply control components in an appropriate manner to satisfy the requirements of the Machinery Directive. Use of components with CE marking does not mean that the machine meets CE requirements. CE marking on a control component usually indicates compliance with the Low Voltage or Electromagnetic Compatibility Directive. The Machinery Directive requirements for the control components are an entirely separate set of concerns. The MD defines machinery as "an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application."
The requirements with which the manufacturer must document compliance are given the Essential Health and Safety Requirements in annex I of the MD. The focus of the MD is to put requirements towards the manufacturer to document that the machinery is safe to use and that the users are properly warned about remaining and residual hazards, if any and exist. The manufacturer can use a suitable harmonised standard as an alternative to the more functional requirements given in the directive.
The nature and diversity of machinery makes the MD a multidiscipline regulation, when it comes to technology aspects to be covered. The key elements are:
· General knowledge about risk assessments