Self Certify Your Machine
The objective of the "Safety of Machinery Directive" 2006/42/EC is to harmonize the national regulations concerning design, manufacturing and supply of machinery by defining 'essential requirements' to ensure its safe use and to remove barriers of trade between member states of the European Union.
The most important information that is not getting through to U.S. machinery manufacturers is that self-certification is permitted for all machinery and allows entrance to all European countries.
The only exception is machinery listed in ANNEX IV of the directive, which are machines such as, circular saws, band saws, presses, devices for lifting persons, underground working machines, etc. (Pretty much all high risk equipment.) A complete listing can be found here Click here for list (PDF)
If you determine that ANNEX IV DOES NOT Apply, the next step is to review the definition of machinery.
'MACHINERY" means:
  • 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 are joined together for a specific application.
  • An assembly referred to above, missing only the components to connect it on site or to sources of energy and motion.
  • An assemble referred in the two above paragraphs, 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 three paragraphs above or partly completed machinery (Defined 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.

Partly completed machinery
means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.
NOTE: CE Marking is required under the machinery directive for partly completed machinery.

The Machinery Directive contains 48 'Essential Requirements', probable better known as 'EHSR'. The EHRS lay down the necessary elements for protecting consumers, workers, property and the environment. Compliance with the ESHR is mandatory. Only products complying with EHSR may be placed on the market and/or put into service.
Only after the manufacturer has demonstrated compliance with the 'Essential Health and Safety Requirements' is he allowed to place the CE Marking on the machine.
One of the major obstacles to complying with the EHSR is the style in which they are written. Another obstacle for U.S machinery manufacturers is the directive requirement that the Technical File be made available to European Authorities quickly-usually taken to mean 48 hours.
QNET can assist you in preparing the Technical File click here for details and act as your European Authorized Representative for regulatory affairs holding your Technical File for the authorities click here for details.

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