After complying with the EU legislation, it is time to affix the CE marking. Where and how should the CE marking be placed? What are the requirements and who is responsible for affixing the marking? In which cases should you specify the identification number of the Notified Body that was involved in the conformity assessment procedure? Let’s take a look at the requirements of affixing the CE marking.
Who affixes the CE Marking?
‘The CE marking must be affixed by the manufacturer (established inside or outside the Union), or by his authorised representative established within the Union’ (European Commission, 2013).
The manufacturer, whether established inside or outside the Union, is the organization ultimately responsible for the conformity of the product with the provisions of the EU legislation and for the affixing of the CE marking. The manufacturer may appoint an authorised representative to affix the CE marking on his behalf.
By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility (and independent of the fact of whether a third-party has been involved in the conformity assessment process), conformity with all of the legal requirements to achieve CE marking.
In the case when an importer or distributor or another operator places products on the market under their own name or trademark or modifies them, they then take over the manufacturer’s responsibilities. This includes the responsibility for the conformity of the product and the affixing of the CE marking. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when affixing the CE marking. (European Commission, 2013)
Principles of Affixing the CE Marking
The CE marking must be affixed before the product subject to it, is placed on the market. Affixing will usually happen at the end of the production phase. As the European Commission states, ‘This poses no problem if, for example, the CE marking is on a data plate that is not affixed to the product until after the final inspection’ (European Commission, 2013). However, when the marking is affixed by stamping or casing, the CE marking can be affixed at affixed at any stage of the production phase.
The mark must take the form as seen in the below picture. The proportions must be respected, if the CE marking is enlarged or reduced.
‘The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents’ (European Commission, 2013).
First of all, the CE marking must be easily accessible for all parties. It can be affixed on the back or underside of the product, and a minimum height of 5 mm is required to ensure that it is legible. However, for small devices or components, according to several pieces of legislation, the minimum dimension of the CE marking may be waived.
As long as it remains visible, legible and respects its proportions, the CE marking can take different forms (e.g. colour, solid or hollow). Also, it must be indelible. In other words, the organization responsible for the affixing must make sure that the CE marking cannot be removed under normal circumstances without leaving noticeable traces. For example, some standards provide for a rub test with water and petroleum spirits. However, this does not imply that the CE marking must for an integral part of the product.
Nevertheless, there are cases when affixing the CE marking on the product is impossible or not possible under reasonable technical or economic conditions. Furthermore, cases when the minimum dimensions cannot be respected, or it cannot be ensured that the CE marking is visibly, legibly and indelibly affixed (European Commission, 2013). In those cases, the CE marking can be affixed to the packaging, it is exists, and/or the accompanying documents. It is not allowed to affix the CE mark to the packing and/or accompanying documents for aesthetic reasons.
The European Commission provides the manufacturers with a wide range of options regarding the design of the CE mark. However, electronic labelling is forbidden.
For more information please review the Decision 768/2008 and Regulation 765/2008, which lay down the CE marking affixing requirements as defined in Annex II of Regulation 765/2008.
The Identification Number of the Notified Body
‘Where a notified body is involved in the production control phase according to the applicable Union harmonization legislation, its identification number must follow the CE marking. The manufacturer or the authorized representative affixes the identification number if the legislation so requires, under the responsibility of the notified body’ (European Commission, 2013).
Depending on the conformity assessment procedure, a Notified Body may be involved. In this case, the CE marking must be followed by the identification number of the Notified Body. However, this happens only when the Notified Body was involved in the production phase. If the Notified Body was solely involved in the design phase, according to module B, the identification number must not follow the CE marking. On the other hand, if several Notified Bodies were involved in the production phase (which is possible where more than one Union harmonization test is applicable), several identification numbers must follow the CE marking.
The CE marking, together with the identification number of the Notified Body do not necessarily need to be affixed in the European Union. For example, when the product is manufactured in a third country and the Notified Body carried out the conformity assessment in that country, the CE marking can be affixed at that location.
The CE marking and the identification number can be affixed separately, as long as they remain combined. In addition to the CE marking and the identification number, some EU legislations require that the last two numbers of the year in which the CE marking was affixed are indicated.
Remember that the ‘CE marking is a key indicator (but not a proof) of a product’s compliance with EU legislation and enables the free movement of products within the European market, whether they are manufactured in the EEA or in another country’ (European Commission, 2013). Affixing the CE marking correctly, is just as important as completing the compliance procedure. Thus, if you reached this stage, please spend the necessary time in order to understand the requirements and affix the CE marking properly.
Sources:
European Commission. (2013). The ‘Blue Guide’ on the implementation of EU product rules.
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