Existing in its present form since 1993, the CE marking is a key indicator of a product's compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on one's 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. This also applies to products made in third countries which are sold in the EEA.
CE marking does not indicate that a product was made in the EEA but states only that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (such as safety, health, environmental protection requirements) of the applicable directive(s) or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.
However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked. CE marked products are bought not only by professionals (such as medical devices, lifts, machinery and measuring equipment) but also by consumers (such as toys, PCs, mobile phones and light bulbs).
Countries requiring the CE marking
The CE marking is mandatory for certain product groups in the European Economic Area (EEA), consisting of the 27 Member States of the EU and EFTA countries Iceland, Norway, Switzerland and Liechtenstein. It is also obligatory for all products made in third countries (non-member states) sold in the EEA. In that case, the importer has to make sure that the manufacturer outside the EU has taken the necessary steps that allow him to affix the CE marking.
It is still not required within the member countries of the Central European Free Trade Agreement (CEFTA), but some of them (Republic of Macedonia, Croatia, Serbia, Montenegro) are official candidates for membership to the European Union, and are already adopting many of its standards within their legislation (like most of the former Central European countries that were members of CEFTA before joining the EU).
Rules underlying CE marking
The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up a technical file and sign an EC declaration of conformity. The documentation has to be made available to authorities on request.
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. Importers should also make sure that contact with the manufacturer can always be established.
Distributors must be able to demonstrate to national authorities that they have acted with due care and they must have affirmation from the manufacturer or importer that the necessary measures have been taken.
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.
There are certain rules underlying the procedure to affix the marking:
- Products subject to certain EC directives providing for CE marking have to be affixed with the CE marking before they can be placed on the market.
- Manufacturers have to check, on their sole responsibility, which EU directives they need to apply for their products.
- The product may be placed on the market only if it complies with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly.
- The manufacturer draws up an EC declaration of conformity and affixes the CE marking on the product.
- If stipulated in the directive(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure.
- If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking.
Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified where manufacturers a Declaration of Conformity and affixes the CE marking to their own product. Manufacturer then must do several things:
- Decide whether the product needs to have a CE marking and if the product applies to more than one directive it needs to comply with all of them.
- Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:
- Module A – Internal production control.
- Module A – Intervention of a Notified Body.
- Module B – EC type-examination.
- Module C – Conformity to type.
- Module D – Production quality assurance.
- Module E – Product quality assurance.
- Module F – Product verification.
- Module G – Unit verification.
- Module H – Full quality assurance.
These will often ask questions about the product to classify the level of risk and then refer to the "Conformity Assessment Procedures" chart. This shows all the acceptable options available to a manufacturer to certify the product and affix the CE marking.
Products considered to have a greater risk have to be independently certified by a notified body. This is an organization that has been nominated by a Member Government and has been notified by the European Commission. These notified bodies act as test labs and carry out the steps as listed in the directives mentioned above and then decided whether the product has passed. A manufacturer can choose its own notified body in any member state of the European Union but should be independent of the manufacturer and a private sector organization or a government agency.