Manufacturers who build parts of machines or incomplete machinery (for example: no controls) must be aware that their equipment must not carry a CE marking and must follow a separate compliance path in the Machinery Directive 2006/42/EC.
This is an important distinction because, in my opinion, it is more complicated (more documentation) to send a partly completed machine versus a fully functioning “machine” to the EU as pertains the MD 2006/42/EC compliance process.
For completed machinery, unless your equipment is under Annex IV, the process is very straightforward. See Article 12 –
This is the usual ‘self-certification‘ process: the manufacturer evaluates the equipment to Annex I usually with the aid of a competent 3rd party testing lab, uses applicable harmonized EN standards to evaluate and test, incorporates technical solutions, puts a CE marking on the equipment and… “off you go.”
For partly completed machinery the process is more complicated. See Article 13 –
This article will not detail every nuance of sending partly completed machinery to the EU but I want to stress three points:
- A CE marking is not allowed on the equipment until the integrator finishes the machine and makes it fully compliant.
- A declaration of incorporation instead of a declaration of conformity must be prepared. The most notable difference besides the title is that on a DoI the manufacturer must list every individual Annex I EHSR that is complied with. That is not done on a DoC.
- Assembly instructions must be prepared. That is kind of an innocuous term for what they really want because what they mean by “assembly instructions” includes any Annex I EHSR’s that are identified as applicable but not complied with because the equipment is not complete. In other words: the manufacturer must say to the integrator, “hey, we see this risk here and you have to address it when you complete the build.”
See the Guide to Application of the Machinery Directive 2006/42/EC, Edition 2.1, Section 390, para 3:
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