General
This information leaflet is intended for manufacturers of machines covered by the Machinery Directive (98/37/EC).
The directive defines a machine as being:
"... an assembly of interconnected parts, at least one of which is able to move, serving a specific purpose ..."
The definition also includes:
"... assemblies of several machines with connected functions, a removable attachment which alters the function of the machine, which is connected to the machine by the operator himself, and which is not a spare part or an engine ..." and
"... separately marketed safety components whose malfunction could endanger people or the environment ..."
What is covered by the directive?
The scope of the definitions above is comprehensive. However, the directive excludes a number of specific product-categories:
Most of the above mentioned product categories are covered by specific EU-directives. Where the safety of an appliance is regulated by another specific directive, the Machinery Directive will cease to apply, or will be applicable only for the typical aspects of the appliance having moving parts.
For example: If risks associated with a machine are also of an electrical nature, the Low Voltage Directive is applicable. Many harmonized standards on low voltage equipment are assigned to the Low Voltage Directive. These standards also contain requirements concerning hazards caused by the moving parts of the equipment. Basically the Machinery Directive remains applicable; however, compliance with a harmonized standard may indicate compliance with the Low Voltage as well as the Machinery Directive.
Where, for machinery, the risks are mainly of electric origin, such machinery shall be covered exclusively by the Low Voltage Directive.
Machines constructed for private use are also subject to essential requirements and CE marking.
Conformity Assessment Modules
In principle Module A applies. However, the Machinery Directive identifies a number of machine-categories comprising those with a high safety risk and a number of safety components. For these products Module Ba applies. Module B requires the involvement of a "Notified Body".
Products for which Module B, applies include:
The following products also come within the scope of the Machinery Directive:
A purchaser who modifies, completes or assembles a machine is, under the terms of the Machinery Directive, a manufacturer and therefore responsible for compilation of the Technical Construction File, conformity with the essential requirements of the directive, drawing up the Declaration of Conformity and applying or reapplying the CE marking.
When did the directive come into force?
The Machinery Directive has come into force on January 1st, 1993, after which there has been a two-year transition period. Starting January 1st, 1995, CE marking on machines is mandatory.