CE Mark Certification
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. Conformité Européenne (CE) certification is a regulatory standard that verifies certain products are safe for sale and use in the European Economic Area (EEA). Manufacturers place a CE marking on certified products to indicate that the product complies with European safety rules and can be traded freely within the EEA.
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good’s conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA), but is also found on products sold elsewhere that have been manufactured to EEA standards.
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 logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. “CE” is the abbreviation of “conformité européenne” (French for “European conformity”).
he 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 mark to a product that is not compliant or offer it 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 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 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 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.
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:
1. Investigate whether the product needs to have a CE marking. The product must conform to all Directives and Regulations that apply to the product.
2. 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 procedures require a “type Approval” and a Production conformity assessment by a Notified Body. The common procedures (modules) of certification are as listed below. A product normally needs more than one procedure (Module) to be implemented:
• Module A – Internal production control.
• 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.
• 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 ensuring that the relevant modules for the product category have been applied, will affix the 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.
Rules underlying CE marking
The formal legal status of the 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:
Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a notified body, is of great importance throughout the entire CE-marking process, from design verification, and set up of the technical file to the EU declaration of conformity. 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.
The norms (directives and regulations) requiring CE marking affect the following product groups:
Characteristics of CE marking
For example, for a machine, generally the Machinery directive applies, but often also:
When the manufacturer of a machine puts the CE marking, it engages itself and guarantees, that it makes all the tests, assessments and evaluation on the product to conform to all the requirements of all the norms that apply to its product.