Important Consideration when Applying the CE Marking
By Koos Gouws
In accordance with the European Union legal requirements, products placed on the market in its member states must bear the CE marking. This is applicable to many products, although there are exceptions. The CE marking is an indication that the product has been assessed to ensure that it is safe for use by an end user, as well as all other parties that may be affected.
Unfortunately, it is not as easy as just putting a CE mark on the product label. Certain general procedures must be followed and there are requirements that must be met. The procedures and requirements are contained in directives and regulations issued by the European Parliament. These directives are written for specific product groups, for example:
The machinery directive
The medical devices directive
The toys directive
The low voltage directive
The pressure equipment directive
In general, each directive or regulation contains the essential safety requirements for the product group, as well as the processes that can be followed to enable the manufacturer to apply the CE marking to the product.
In many cases, a distinction is made between dangerous products and products which are not regarded as dangerous. In some cases there may only be the 2 possibilities, while in others more categories may be possible (4 in the case of the pressure equipment directive and the medical devices directive).
Normally, if a product is regarded as not dangerous, the manufacturer will follow the correct procedures and issue a certificate of compliance, and then apply the CE marking. When the product is regarded as dangerous, a notified body will be involved. A notified body is an organization "notified" by the European Parliament that they may assess certain product groups and, if acceptable, issue an EC certificate of compliance. Once the certificate has been issued by the notified body, the manufacturer may issue its own certificate of compliance, and apply the CE marking.
Organizations such as ours (SHEQ Management Systems) are not notified bodies, but we guide manufacturers through the correct process. We also help with the identification of hazards, and with the risk assessment. Often we will also compile the technical file or design dossier, whichever may be applicable. If a notified body is involved, we will prepare everything for presentation to the notified body.
It is always best to contact us when the product is in the design stage. It may save a lot of time and possibly additional costs later on. In certain cases, manufacturing and assembly may only start after permission has been received from a notified body. For example, in the case of the pressure equipment directive, when products are in category 3 or 4, the notified body will look at the design documentation before manufacturing and testing may start. If they are satisfied, they will issue an EEC construction testing certificate, after which the manufacturing, assembly and testing may start. After completion, they will assess the design dossier with all the test results and other document requirements, and then issue an EC certificate of compliance. Only then may the manufacturer apply the CE marking.
To make things even more complicated, there are sometimes more that 1 process available, depending on the quality system of the manufacturer. In some cases more than 1 directive may be applicable as well. It is often bets to get assistance from a knowledgeable source, such as a consultant.
It is essential to follow the correct procedures for the application of the CE marking. The EU is tightening its control over products being distributed in member states. Governments are required to carry out random inspections on products which are distributed in their individual countries, and there are harsh penalties if non-conformances are found. The manufacturer is also reported to the authorities to ensure that all member states can act accordingly.
It is also essential to realise that the US requirements for products are not necessarily the same as the European requirements. We have found that pressure equipment built in accordance with the ASME codes does not comply with all the essential requirements of the pressure equipment directive.
The application of the CE marking can be a minefield if an organization is not sure how to do it. The financial implications can be enormous if the equipment does not comply with the requirements of the directives.
Please feel free to contact us if more information is required. SHEQ Management Systems can assist organizations which require information or assistance regarding the application of CE Marking to their products. We will help to make the process as easy as possible. Organizations will have access to expert advice on compliance with the relevant directives or regulations so that the CE Marking can be applied with confidence to their products.
For further information and to find out how SHEQ Management Systems can assist you in this regard, please contact us.