Principles, Standards and Implementation

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Regulations

EU Directives and Legislation The EU Machinery Directive Essential Health and Safety Requirements The Machinery Directive—Conformity Assessment and Standards Technical File Conformity Assessment Notified Bodies
EC Declaration of Conformity Procedure EC Declaration of Incorporation for Partly Completed Machinery Machinery Supplied from Outside the EU—
Authorized Representatives		 The EU Use of Work Equipment Directive (U.W.E. Directive) U.S. Regulations Occupational Safety and Health Administration Canada Regulations
Conformity Assessment

Certain types of equipment are subject to special measures. This equipment is listed in Annex IV of the Directive and includes dangerous machines such as some woodworking machines, presses, injection molding machines, underground equipment, vehicle servicing lifts, etc.

Annex IV also includes certain safety components such as Protective devices designed to detect the presence of persons (e.g. light curtains) and logic units for ensuring safety functions.

Click to enlarge - Principles_Figure 05 (Annex IV)
 
Figure 4: Conformity Assessments

For Annex IV machines that are not in full conformity with the relevant Harmonized European Standards the manufacturer or his authorized representative must apply one of the following procedures:

1. EC Type Examination. A Technical File must be prepared and an example of the machine must submitted to a notified body (test house) for EC type examination. If it passes, the machine will be given an EC type examination certificate. The validity of the certificate must be reviewed every five years with the Notified Body.
2. Full Quality Assurance. A Technical File must be prepared and the manufacturer must operate an approved quality system for design, manufacture, final inspection and testing. The quality system must ensure conformity of the machinery with the provisions of this Directive. The quality system must be periodically audited by a Notified Body.

Click to enlarge - Principles_Figure 06 (Approved)
 
Figure 5: Notified Body Examinations

For machines that are not included in Annex IV or machines that are included in Annex IV but are in full conformity with the relevant Harmonized European Standards, the manufacturer or his authorized representative also has the option prepare the Technical and self assess and declare the conformity of the equipment. There must be internal checks to ensure that the manufactured equipment remains in conformity.