CE Marking. The mark that makes Europe stand out from the rest
“What concepts are usually linked to the CE Marking? In most cases, “Europe” and “Safety”.
Well, these are two of the reasons why the European Union, at that time known as European Community, created this mark.
The EU has always had the “free movement of people” and “safety of people” among its basic principles. In this case, it focuses on the free movement of goods and their safety. The different rules applied in each of the member countries was jeopardising such principles, thus a new strategy called “New Approach” was developed aiming to harmonise legislation and create a common technical environment that would enable the free movement of products and commercialisation of safe goods among EU countries.
This strategy is developed by means of what are known as “New Approach Directives” that have favoured the harmonisation of legislation in the EU internal market, since it forces each member country to adopt them as part of their national legislation.
The CE Marking is just the mark and stamp of distinction that products must bear when, provided that they are covered by the directives, they comply with the essential and applicable safety requirements.
It is up to the manufacturer or importer, if the former is not based in any of the member countries or does not have a legal representative in any of them, to ensure that their products comply with the obligations inherent in the CE Marking.
This responsibility involves checking that the goods comply with the essential requirements of the applicable directives and follow the assessment procedures in conformity with provisions established in the directives, which are different depending on the type of product and on its end use.
Once the relevant requirements have been met according to the appropriate procedure, the data required in the “Technical File” shall be compiled, including the product information and description, proof of compliance with the essential requirements, etc.
All this documentation supports the “CE declaration of conformity” that shall go with the products, the content of which is described in each directive. It shall at least include the following: Name and address of the manufacturer or of the person in charge authorised to issue the declaration, product identification, normative reference, date in which the declaration is issued, signature and position of the authorised person.
All this documentation will be at the disposal of the relevant administrative authority in terms of market surveillance.
In a nutshell, these are the steps to be taken to be able to affix the CE Marking to a product.
Which are the main difficulties that manufacturers face regarding the CE Marking?
When wishing to market a product in the EU, whether it is a newly designed one or a product that is to be imported from outside the EU, the main difficulty is knowing whether the product is influenced by any of the new approach directives. The biggest effort shall be made at this stage to find out whether the product is affected by any directive.
New approach directives include lists containing the products affected by them; these are the ones that must bear the CE Marking and therefore must comply with all the obligations it entails.
Directives, in turn, develop the conformity assessment procedures referring to the checks to be performed on the product, making a difference between two stages, the design and the manufacturing stages. The procedures to be followed have been classified by modules and, depending on the one that is applied, there will be more or less strict compliance requirements. These checks will be more stringent or complex depending on the product they deal with, owing to the safety level that the product must involve for users.
Once the goods are introduced into the market, the administrative authorities of each delegation, and in the case of Spain the Regional Governments, are responsible for performing market checks that ensure that the applicable provisions are met in the region and contribute to reaching the adequate level of citizen security. Legislation currently in force in the CE Marking field will ensure that no unsafe products that can build distrust among consumers are introduced into the market.
In brief, the CE Marking shall convey confidence and safety.