Frequently Asked Questions

For Low Voltage Directive. EMC Directive third party certification is not mandatory, but the Directives include provision for Notified Body reports or opinions to be provided as proof of conformity in some circumstances.

For Machinery Directive, Notified Body certification is only mandatory for Annex IV equipment which does not fully conform with the requirements of harmonised C type standards. However a manufacturer can request a Notified Body EC Type Examination certificate for any Annex IV equipment. Machinery Directive does not legally recognise any other form of certification but "voluntary" third party certificates are common, to give buyers confidence.

Clients have no legal right to demand a copy of a technical file, but they may make provision of a technical file a contractual requirement. Only EU enforcement bodies have a legal right to demand a technical file.

Although it is not necessary to have a technical file immediately available, it is legal requirement that you must be able to produce one within a "reasonable time". This is normally regarded as about two weeks. It is advisable to prepare a technical file as part of your assessment of conformity to check that your products really do meet EU requirements.

CE marking is essentially only relevant within the EU and EEA, but some countries which expect to join the EU soon, such as country, have already implemented CE marking requirements for imports. In other countries a CE marking, although without any legal meaning can be regarded as an indication of a quality product.

CE marking Directives do not cover all possible goods offered for sale. If a product is not covered by a CE marking directive, it cannot carry a CE marking. If it is covered it must carry a CE marking. This can lead to some strange situations. Vehicle jacks to lift the side of a vehicle to change a tyre are lifting equipment and therefore covered by CE marking Machinery Directive, but axle stands used to support the vehicle body once it has been lifted are supporting, not lifting equipment. There is no CE Directive for them so they cannot carry a CE marking.

In most cases, no, but for partially completed machinery, for example an engine with an unguarded shaft, or a robot designed to work inside a safety fence, there is provision for a Declaration of Incorporation, in which the manufacturer declares that the equipment can only be put into use in the EU in a complete system which has been assessed for CE conformity. In this case, if other CE marking directives also apply, a CE marking can be affixed, showing complete conformity with those.

Strictly speaking, yes, but in practice, the most important thing is that the equipment you build is actually safe. The CE marking process and compilation of a technical file with a risk assessment and check against the requirements of harmonised standards provide a well structured and well accepted way of showing that you have taken adequate measures to ensure that. If you have been through the CE marking process, making Declaration of Conformity and adding a CE nameplate is a minor addition which gives you full compliance with the law.

Yes. If the machine is not imported with a CE marking and Declaration of conformity from the US supplier, you, as the person putting the equipment into use in the EU carry the legal responsibility for its conformity. The situation is then as in the question above.

Conformity with the requirements of the Directive is mandatory, testing is not. The EMC Directive requires that the equipment will not suffer from, or cause, any unacceptable EMC effects. Standards provide some more definition of what that means in practice.

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