CE Marking & Conformity
CE marking is an indicator that a product complies with EU legislation and enables the free movement of products within the European market. When a manufacturer affixes the CE marking on a product, he declares, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area, Switzerland and Turkey.
This also applies to products made in third countries which are sold in the EEA, Switzerland and Turkey. CE marking does not indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and meets the EU safety, health and environmental protection requirements. It means that the manufacturer has verified that the product complies with all relevant essential requirements of the applicable directive(s) or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.
It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the EC declaration of conformity and to affix the CE marking on the product. Distributors must verify the presence of both the CE marking and the necessary supporting documentation. If the product is being imported from a third country, the importer has to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.
Not all products must bear the CE marking. Only those product categories subject to specific directives (New Approach Directives) that provide for CE marking are required to be CE marked. There are more than 20 directives setting out the product categories requiring CE marking. The products range from electrical equipment to toys and from civil explosives to medical devices. The essential requirements that products have to fulfil are harmonized at EU level and are set out in general terms in these directives.
Harmonised European standards are issued with reference to the applied directives and express in detailed technical terms the essential requirements. The two main sources to find harmonised standards are the European Commission website and the New Approach website. Full compliance of a product with the harmonised standards gives a product the “presumption of conformity” with the relevant essential requirements. While the CE marking is mandatory, the use of harmonised standards remains voluntary. Other ways to fulfil these essential requirements can be chosen.
All conformity assessment activities are aimed at testing or proving that the product concerned complies with the essential legal requirements. The manufacturers shall identify the conformity assessment procedure that must be taken; this could either be self-declaration, involve testing inspection or quality system assessment from a Notifies Body or a combination of them. The Global Approach was specified by the modular approach for the assessment of conformity with the New approach Directives. There are independent, indivisible and complementary modules. The modules are designated by the letters A to H. As the EU favours a free-market economy a broad choice between the modules must be left to the manufacturer. When the valid directives not prescribe a procedure, the manufacture is then at liberty to choose the conformity assessment procedure himself. The most widely used is Module A.
Modules for the Conformity Assessment Procedures
Module A – Internal production control
Module B – EC type-examination
Module C – Conformity by type
Module D – Production quality assurance
Module F – Product verification
Module G – Unit verification
Module H – Full quality assurance
Each directive covering a product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. These Bodies are authorised by national authorities and officially “notified” to the Commission and listed in the database NANDO IS (New Approach Notified and Designated Organisations) for all New Approach sectors but construction and in NANDO CPD for construction products.
The manufacturer has to establish the technical documentation required by the directive(s) for the assessment of the product’s conformity to the relevant requirements, and for the risk assessment. Together with the EC declaration of conformity, the technical documentation must be presented on request to the relevant national authorities.
Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. If importers or distributors market the products under their own name, they take over the manufacturer’s responsibilities. 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 they affix the CE marking.
Affixing of the CE Marking
The CE marking must be at least 5 mm, if enlarged its proportions have to be kept.
The CE marking must be affixed by the manufacturer, or by his authorised representative. It must be affixed according to its legal format visibly, legibly and indelibly to the product or its data plate. If a Notified Body was involved in the production control phase, its identification number must also be displayed. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives.
Declaration of Conformity
It is the manufacturer’s responsibility to draw up and sign an “EC declaration of conformity” proving that the product meets the requirements. Once the CE mark is affixed to a product it must be supported by an official Declaration of Conformity or DOC in which the manufacturer declares that the product concerned is in compliance with the essential requirements out of the European Directives in force. Prior to this the product may not be sold on the European internal market.
The EC Declaration of Conformity basically contains the following elements:
- Name and full address of the manufacturer and, sometimes, his representative
- Product identification (name, function, model, type, serial number and the commercial name and all relevant additional information)
- The applied Directives and sometimes the harmonised standards or other applied technical standards and specifications
- Sometimes the name and address of the person authorised to compile the Technical File; this person should be located within the Community
- Sometimes the name, address and identification number of the Notified Body
- The name and signature of the person accepting responsibility of drafting the declaration on behalf of the manufacturer or authorised representative
- The date of issue.
In order to promote trade in goods between EU and candidate countries and EU and third countries by facilitating market access, Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products> (PECAs) and Mutual Recognition Agreements (MRAs) have been negotiated respectively. They are bilateral agreements, and aim to benefit industry by providing easier access to conformity assessment procedures.