CE marking and conformity with EU requirements is a complex topic. If your equipment does not fully meet all requirements you may have problems with clients and enforcement agencies. PTS Testing Service can provide advice on routes to conformity and requirements for design and documentation and will ensure that you are conforming with all necessary Directives and applying the correct standards.

HOW DOES CE MARKING WORK?

Although a CE marking is generally perceived as a safety marking, it is in fact a Free Trade marking. The intent of CE marking Directives is to ensure that the same product can be offered for sale anywhere in the EU by ensuring that technical requirements are the same for all EU member states.

If a product carries a CE marking, the manufacturer or importer is claiming access to the EU market because the product meets all the relevant requirements of all relevant Directives.

CE marking Directives cover a variety of different types and aspects of equipment. The current list is:

Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Eco-design of energy related products
Electromagnetic compatibility
Equipment and protective systems intended for use in potentially explosive atmospheres
Explosives for civil uses
Hot-water boilers
Household refrigerators and freezers
In vitro diagnostic medical devices
lifts
low voltage
machinery
Measuring instruments
Medical devices
Noise emission in the environment
Non-automatic weighing instruments
Personal protective equipment
Pressure equipment
Pyrotechnics
Radio and telecommunications terminal equipment
Recreational craft
Safety of toys

Simple pressure vessels

PTS Testing Service specialises in Personal Protective Equipment, Machinery, EMC for electronics Directives. These cover most industrial and consumer products, but we know a lot about other Directives as well, so even if we cannot help you directly, we may be able to provide some useful advice or point you to someone else who can help.

Not absolutely all products are covered by CE marking Directives but, those which are not still fall within the scope of the General Product Safety Directive. This places a duty on manufacturers and importers of equipment to ensure that these products are safe in normal and intended use.

CE marking Directives contain Essential Requirements which are the fundamental basis of conformity. Technical details of how the requirements can be met are provided by EN harmonised standards.

For most equipment, manufacturers can make their own assessment of whether their equipment meets the requirements of the Directives but in some Directives or for some classes of equipment it is necessary for a Notified Body to inspect the items and give some kind of certification.

Is third party certification mandatory for CE marking?

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.

Must I create a Technical File and show it to my clients?

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.

Does CE marking have any meaning outside the EU?

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.

Must all products on sale in the EU require a CE marking?

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.

If a product meets the requirements of some but not all relevant CE marking Directives, can it 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.

If I build a machine for my own use, must I go through the CE marking process?

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.

I am building a piece of electronic equipment, is it mandatory for it to be tested for EMC?

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.