CE marking is a mark () that must be affixed to certain commercial products to indicate that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. The mark is not a quality indicator or a certification mark. The CE marking is required for relevant goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.
The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE letter pair and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure.
Overview The CE mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economic Area (EEA). It is a criminal offence to affix a CE mark to a product that is not compliant or to offer such a product for sale.
For example, most electrical products must comply with the Low Voltage Directive and the EMC Directive, among others; toys must comply with the Toy Safety Directive. (The Low Voltage Directive is about electrical safety; EMC or Electromagnetic Compatibility means the device will work as intended without interfering with, or being affected by, the use or function of any other device.) The CE mark indicates compliance with as many norms (directives and regulations) as apply at the time of the declaration of compliance (see below). In the case of electrical products, several later norms such as the Restriction of Hazardous Substances Directive (RoHS) and Waste Electrical and Electronic Equipment Directive (WEEE) are relevant in addition to the Low Voltage Directive and EMC Directive. The exact significance of the CE mark therefore depends on when it was applied to a specific unit.
The marking does not indicate EEA manufacture or that the EU or another authority has approved a product as safe or conformant. The EU requirements may include safety, health, and environmental protection. If stipulated in any EU product legislation, assessment by a Notified Body or manufacture according to a certified production quality system may be required. Where relevant, the CE mark is followed by the registration number of the notified body involved in conformity assessment.
Not all products need CE marking to be traded in the EEA; only product categories subject to relevant directives or regulations are required (and allowed) to bear CE marking. Most CE-marked products can be placed on the market subject only to an internal production control by the manufacturer (Module A; see Self-certification, below), with no independent check of the conformity of the product with EU legislation; ANEC has cautioned that, amongst other things, CE marking cannot be considered a "safety mark" for consumers.
Meaning of CE Although it has been suggested that the CE letter pair is an abbreviation of (as used, for example, in a written question in the European Parliament), this meaning appears to be a backronym. None of the defining EU Directives or EU Regulations give this association. When the Commission replied to the written question, they did not repeat or acknowledge those words. However, in a 2014 press release, the Commission gave CE as an abbreviation of . This is the only quasi-validation of the term that has been publicly released by a European authority.
Countries requiring CE marking CE marking is mandatory for certain product groups intended for sale within the European Union, the European Free Trade Association (EFTA), and Turkey. As Northern Ireland (a region of the UK) remains aligned to the European Single Market under the Northern Ireland Protocol, CE marking remains mandatory for products placed on the market there, and the British UKCA mark is not required.
CE marking was not required by countries of the Central European Free Trade Agreement (CEFTA), but CEFTA members Albania, North Macedonia, Serbia, and Montenegro had applied for membership of the European Union, and were adopting many of its standards within their legislation, as had most Central European former member countries of CEFTA that joined the EU, before joining.
, the United Kingdom government "intends to extend recognition of the CE marking for placing most goods on the market in Great Britain, indefinitely, beyond December 2024", with "different rules for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, marine equipment and ecodesign".
Rules underlying CE marking The formal legal status of the CE mark is set out in various EU Directives and Regulations. The underlying principles are explained in the Commission's "Blue Guide".
Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer.
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 a Declaration stipulated by the leading legislation for the product. 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 EU directives or EU regulations 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 legislation 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 regulations and if the conformity assessment procedure has been carried out accordingly. The manufacturer draws up an EU declaration of conformity or a declaration of performance (for Construction Products) and affixes the CE marking on the product. If stipulated in the directive(s) or regulation(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure or in setting up a production quality system. 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.
A guide to the implementation of directives and regulations based on the New Approach and the Global Approach (the "Blue Guide") was first published by the European Union in 2000. Updated versions were published on 28 February 2014 and 26 July 2016.
Self-certification
Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. Self-certification exists only for products that have a minimal risk for their use, and this is clearly foreseen in the relevant directive and regulation according to the product "category". In order to certify, the manufacturer must do several things:
Investigate whether the product needs to have a CE marking. The product must conform to all Directives and Regulations that apply to the product. Choose the conformity assessment procedure from the modules called out by the directive or the regulation for the product according to each category (level of risk) involved. There are several modules available for the Conformity Assessment Procedures, but only a few of them involve self-certification. The most of these procedure require a "type Approval" and a Production conformity assessment by a Notified Body. All procedures (modules) of certification are as listed below which are derivered from Article 5.1.7 of "Blue Guide". A product normally needs more than one procedure (Module) to be implemented: Module A – Internal production control. Module A1 – Internal production control plus supervised product testing Module A2 – Internal production control plus supervised product checks at random intervals Module B – EU type examination. Module C – Conformity to EU type based on internal production control Module C1 – Conformity to EU type based on internal production control plus supervised product testing Module C2 – Conformity to EU type based on internal production control plus supervised product testing Module D – Conformity to EU type based on quality assurance of the production process. Module D1 – Quality assurance of the production process. Module E – Conformity to EU type based on product quality assurance Module E1 – Quality assurance of final product inspection and testing Module F – Conformity to EU type based on product verification. Module F1 - Conformity based on product verification. Module G – Unit verification. Module H – Full quality assurance. Module H1 – Full quality assurance and Design Examination.
The level of risk is defined by the "category" of each equipment. The higher the category, the higher the risk. After defining the category, the manufacturer, in order to obtain certification, shall then apply the relevant procedures for the specific category of the product or choose the relevant procedures for a higher-category product. The manufacturer, after insuring that the relevant modules for the product category have been applied, will affix the CE mark and draw up a Declaration of Conformity. The Declaration of Conformity contains a description of the product, the directive(s) and regulation(s) applied, the product category for each directive or regulation, the module chosen, and the name and registration number of the notified body involved in certification procedures (models).
Notified bodies involved in certification procedures are organizations that have been nominated by a member state (according to an accreditation procedure) and have been notified by the European Commission. These notified bodies act as Independent Inspection organizations and carry out the procedures as listed in the relevant Modules applied as stated by the relevant directives and regulations. A manufacturer can choose any notified body (notified for the certain directive or regulation and relevant Modules) in any Member State of the European Union.
In reality, the self-certification process consists of the following stages:
Stage 1: Identify the applicable norm(s)