The Machinery Directive 2006/42/EU is a formal legal requirement for CE marking to enter the marketplace or be placed into use in the European Union. The Machinery Directive identifies the basic requirements for Machinery and equipment under its scope to address essential health and safety requirements. This includes the health and safety to machinery users or operators, as well as conditions for safety to other equipment and installations. In addition, the Machinery Directive requires those companies or importers of equipment considered Machinery to meet the following criteria:

  • Undergo Conformity Assessment as required by the Machinery Directive
  • Meet all of the relevant essential health and safety requirements, using harmonized standards or other acceptable means
  • Provide user instructions in the language of the end user. User instructions essential for health and safety should be provided in printed form.
  • Establish and maintain a technical file to demonstrate compliance with the above processes and requirements. This must be kept securely for at least 10 years from the last dates of manufacture and be made available on request to market surveillance authorities
  • Be CE Marked and display the CE mark per the CE Marking Directive
  • Use a Declaration of Conformity signed by an appropriate representative of the company that is placing the equipment into use or on the market in the EU.

The Machinery Directive identifies and provides definitions for machinery:

  • 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
  • an assembly referred to in the first indent (above), missing only the components to connect it on site or to sources of energy and motion
  • an assembly referred to in the first and second indents (above), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure
  • assemblies of machinery referred to in the first, second and third indents (above) or partly completed machinery (also a defined term, see below) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
  • an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort

The scope of the Machinery directive identifies categories of equipment:

  • Machinery and Accessories
  • Interchangeable Equipment
  • Safety Components
  • Lifting Accessories
  • Chains, Ropes and Webbing
  • Removable Mechanical Transmission Devices
  • Partly Completed Machinery

Medical devices are not specifically excluded, as the general exclusion for machinery types that are covered by more specific Directives applies.  In this case such machinery would normally be covered by the Medical Devices Directive that states that where a relevant hazard exists then the machinery shall also meet the essential health and safety requirements in annex I of the Machinery Directive if they are more specific to the machinery than those in the Medical Devices Directive.

There are other categories that are excluded from the Machinery Directive as they are covered under other directives, such as the Low Voltage Directive:

  • Household appliances intended for domestic use
  • Audio and video equipment
  • Information technology equipment
  • Ordinary office machinery
  • Low-voltage switch gear and control gear
  • Electric motors

D.L.S. supports Machinery Directive requirements that include testing to harmonized standards, including evaluation for risk assessment, construction review of the equipment and safety critical sub components, plus any associated accessories that are supplied with the equipment.

The most common harmonized standard is:

EN 60204-1 Safety of machinery – Electrical equipment of machines – Part 1: General requirements for Safety.

This standard is one of 50 additional standards identified as acceptable, all or in part to show compliance to the Machinery Directive.

For more help in determining the specific requirements for your equipment and to establish a CE compliance program contact the D.L.S. technical team to review today.