The Process of CE Marking for Machinery
The CE Marking process for machinery requires the following steps:
1. Decide which directives are applicable to your product.
2. Ensure that your product is compliant with the applicable directives.
3. Compile and retain a technical file, which satisfies the requirements of the directives.
4. Write and sign a Declaration of Conformity, which has a format which satisfies the requirements of the applicable directives, and keep the original with the technical file.
5. Apply CE marking to the equipment in accordance with the requirements of the directive.
6. For series manufacture, document the internal measures that will be implemented to ensure that all manufactured machinery remains in conformity with the provisions of the Directive.
To those unfamiliar with the CE marking process, the EC directives can seem confusing and the simple steps described above be quite complex when addressing the requirements in detail. Advice and technical testing services from an external expert can usually speed up the CE marking process and get the product to market much faster than would otherwise be the case.
Here are a few tips for CE marking your machinery:
1. Decide which directives are applicable to your product
Generally the Machinery Directive 98/37/EC* [ PDF 397 kB ] is applicable to machines, but there are some situations where other directives cover a specific class of machinery. In these cases the machine is excluded from the machinery directive since it is covered elsewhere. There is a section in the machinery directive which details the exclusions [ PDF 529 kB ].
Since the majority of machines have electrical features, the Low Voltage directive 2006/95/EC [ PDF 431 kB ] is often applicable. If the machine does have electrical or electronic features, the EMC directive 2004/108/EC [ PDF 1602 kB ] is also applicable unless the product is excluded in article 1 of the EMC directive.
The requirements of other directives, such as the Pressure Equipment Directive, may also apply, but the Machinery Directive 98/37/EC [ PDF 397 kB ], the EMC directive 2004/108/EC [ PDF 1602 kB ] and the Low Voltage directive 2006/95/EC [ PDF 431 kB ] are the EC directives to be considered for the CE marking for most machines.
* Machinery Directive 98/37/EC [ PDF 397 kB ] will be applicable until 29/12/2009 when it will be replaced by 2006/42/EC [ PDF 1401 kB ]
2. Ensure that your product is compliant with the applicable directives
3. Compile and retain a technical file, which satisfies the requirements of the directives
The above two steps tend to merge into each other since the key requirements of the directives are satisfied by the process of compiling a compliant technical file. If more than one directive is applicable, the technical file must fulfil the requirements of all applicable directives. For some machines, there are additional requirements not covered by the compilation of a technical file. In the case of the machinery directive, some machines are considered to be sufficiently hazardous that the involvement of a Machinery Notified Body is mandatory. A list of Machinery, which falls into this category, is included in Annex IV of the Machinery Directive [ PDF 529 kB ].
There are common features in the technical files requirements for the EMC directive, Machinery directive and Low Voltage directive; all make reference to harmonised standards. Compliance with harmonised standards provides presumption of conformity to the corresponding essential requirements of the EC directives.
Harmonised standards are published in the Official Journal of the European Union and also appear on European Web Sites. Where a harmonised standard applicable to the product being marked exists, its use is recommended as a route to establishing compliance with the applicable directive.
4. Write and sign a Declaration of Conformity, which has a format which satisfies the requirements of the applicable directives, and keep the original with the technical file.
The requirement to keep the original with the technical file is mandated by the Machinery directive 2006/42/EC
The required content for the Declarations of Conformity for the following directives can be found here:
Declaration content for Machinery directive [ PDF 4351 kB ]
Declaration content for EMC directive [ PDF 309 kB ]
Declaration content for Low Voltage directive [ PDF 308 kB ]
5. Apply CE marking to the equipment in accordance with the requirements of the directive.
In addition to the technical requirements of demonstrating compliance with the EC directives, there are requirements for the placing of the CE marking on the equipment. It is also essential that other marks placed on the equipment do not confuse or imitate the CE marking.
6. For series manufacture, document the internal measures that will be implemented to ensure that all manufactured machinery remains in conformity with the provisions of the Directive.
When it is intended to produce many products of the same design, there is an additional requirement for the company placing the product on the market, they must develop internal measures which will ensure that the machinery manufactured will retain the same construction and other aspects as described in the technical files. This is usually achieved through the implementation of a formal quality management system.
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