Procedure for obtaining the CE mark
1. Complying with the essential health and safety requirements laid down in Annex I of the MD
2. Observing all other relevant directives
3. Compiling technical documentation
4. EC prototype testing, where necessary
5. Issuing a Declaration of Conformity
6. Attaching the CE mark
Area of application of the new MD
The Directive applies to the following products:
• Interchangeable equipment
• Safety components
• Lifting accessories
• Chains, ropes and webbing used for lifting
• Removable mechanical transmission devices
• Partly completed machinery
“Partly completed machine”
This is defined as a single entity that almost constitutes a machine, and can be taken as an entity in and of itself, but is unable to perform a specific function by itself.
A drive system is a partly completed machine. A partly completed machine is only intended to be incorporated into or added to other machines, other partly completed machines, or equipment, for the purpose of forming a machine (within the sense of this Directive) with them.
Changes for “partly completed machinery”
Requirements for “part machinery” (also known as “partly completed machinery”) have been re-established in the amended version of the Machinery Directive.
In cases where a manufacturer’s declaration was sufficient in the past, the manufacturer will in future need to supply a declaration of incorporation. This must specify the requirements of the Directive that affect the part machine in question and those that have been adhered to.
Installation instructions must be supplied with the documentation for the machine.
Essential health and safety requirements
Now, the essential health and safety requirements (Annex I) will require the manufacturer to carry out a risk assessment (see EN ISO 12100).
Other changes affect requirements in areas such as:
• Control systems and protective devices
• Noise and vibration emissions