What is CE marking?
The abbreviation CE means "Conformité Européenne" (French: "European conformity"). The CE marking is a conformity mark that informs consumers that a product complies with the specific, mandatory EU directives.
Which products require CE marking?
If a product falls under one or more of the following directives and regulations, it must comply with them and bear the CE mark:
- Directive 2006/42/EC (Machines, soon replaced by Machinery Regulation MVO)
- Directive 2000/14/EC (noise emissions for outdoor machinery, "Outdoor Directive")
- Directive 2014/35/EU (electrical equipment for use within certain voltage limits, "LVD", "low voltage directive")
- Directive 2014/30/EU (electromagnetic compatibility, "EMC Directive")
- Directive 2014/53/EU (radio equipment, "RED", "RTTE")
- Directive 2011/65/EU (hazardous substances in electronics, "RoHS"; or supplement 2017/2102/EU ROHS III")
- Directive 2009/125/EC ("Eco design Directive")
- Regulation (EU) No 305/2011 (construction products)
- Regulation (EU) 2017/745 (medical devices, active implantable medical devices)
- Regulation (EU) 2017/746 (in vitro diagnostics, "IVDR")
- Directive 2014/29/EU (simple pressure vessels)
- Directive 2014/68/EU (pressure equipment)
- Directive 2014/34/EU (Protection systems in hazardous areas, ATEX directive")
- Directive 2007/23/EC (pyrotechnic articles)
- Directive 2014/28/EU (explosives for civil purposes)
- Regulation (EU) 2016/425 (personal protective equipment)
- Directive 2014/31/EU (non-automatic scales)
- Directive 2014/32/EU (measuring instruments)
- Regulation (EU) 2016/426 (gas combustion, gas consumption equipment)
- Directive 92/42/EEC (hot water boilers, "boiler efficiency directive": amended by Directive 2008/28/EC)
- Directive 2009/48/EC (safety of toys)
- Directive 2014/33/EU (lifts)
- Regulation (EU) 2016/424 (cable cars)
- Directive 2013/53/EU (pleasure craft)
- Regulation (EU) 2019/1009 (fertilizer)
The full texts of these directives and regulations are freely accessible online at eur-lex.europa.eu.
How do EC marks, CE marks and CE marks differ?
„EG-Marking“ and „CE-Marking“ are obsolete terms for the CE mark. The current term CE-Symbol refers to the illustration of the letters CE (see below). The term "CE marking" refers to the conformity assessment procedure.
What is the difference between CE regulations and directives?
EU regulations have an effect in all member states immediately after their entry into force, while EU directives must first be transposed into national laws.
Do I need to apply the WEEE Directive for CE?
Directive 2012/19/EU on the disposal of waste electrical equipment or WEEE (Waste of elektrical and electronic equipment) does not trigger the CE conformity presumption principle. This means that although it must be used for electrical and electronic devices, it is not related to the CE mark. In Germany, the directive is transposed into national law by the ElektroG or the ElektroStoffVerordnung.
Do I need a CE mark if my product is covered by the Product Safety Directive?
No, there are also EU directives that do not trigger the principle of presumption of conformity. The Product Safety Directive (Directive 2001/95/EC) is one of them. As of 13 December 2024, the Directive will be replaced by Regulation (EU) 2023/988.
Other directives not relevant to CE are Directive 94/62/EC on packaging and their waste, Directive (EU) 2016/797 and 2007/32/EC on railways and Directive 2014/90/EU on marine equipment.
What does the CE mark mean?
If a product carries the CE mark, this means:
- The product falls within the scope of at least one CE-relevant EU directive or regulation
- The manufacturer has carried out/had a conformity assessment procedure carried out.
- The product meets the EU-wide requirements for health, environmental and safety protection.
These requirements are set out in the CE directives and regulations covering various products such as medical devices, toys, machinery, electrical equipment, personal protective equipment and construction products.
What is a harmonised standard?
Harmonised standards are a special category of European standards which the European Commission has commissioned from a European standardisation body. They were developed by European standardisation organisations such as CENELEC, ETSI and CEN. These standards support European legislation and help ensure that product design and production comply with EU directives through standardised design specifications for specific products. These EN standards are implemented in national (in Germany DIN) standards. Lists of harmonised European standards are published in the Official Journal of the European Union. However, the situation is unclear, as these lists are constantly updated. The experts at easyCE are up to date and are happy to support you.
What is the conformity assessment procedure?
Decision No 768/2008/EC lays down the guidelines and criteria for the conformity assessment process of products. The modules explain procedures that can be applied to the products regulated in the CE directives and regulations for specific conformity assessment. These modules differ in their complexity.
If the risk is not high and the products are manufactured in accordance with the harmonised standards, the manufacturer carries out the entire conformity assessment himself (declaration of conformity, affixing the CE mark and placing on the market). Of course, he can be supported by third parties, such as the experts from easyCE. If the risk is high or no harmonised standard is used, modules are applied that require the involvement of a third party or a notified body.
When should the CE conformity assessment modules be used?
The conformity assessment procedure includes both the design and the design. Design and production phase of the product, while the module applies to either one or both phases. Each conformity assessment procedure is aimed at compliance with the relevant regulations.
Depending on the module, the following steps are provided for the conformity assessment based on the design:
- Internal control of production (Module A)
- Type examination (module B)
- Verification (module G)
- Comprehensive quality assurance (Module H)
Depending on the module, the following steps are carried out during conformity assessment in production:
- Internal control of production (Module A)
- Type conformity (module C)
- Quality assurance of production (Module D)
- Quality assurance of products (module E)
- Product testing (module F)
- Unit verification (Module G)
- Comprehensive quality assurance (Module H)
What do the modules say?
The following table describes which steps the individual modules require.
How do I obtain the CE marking?
Follow the steps below to place your product with CE marking on the market. If you have any questions or would like to leave the work to experts, do not hesitate to contact easyCE.
- Step 1: Research the applicable policies
Find out if your product needs a CE marking or not. Only certain products that fall within the scope of the CE-relevant EU directives and regulations must be marked with the CE mark. Products that require CE marking include machinery, toys, electrical equipment, medical equipment, wireless equipment, PPE, construction products and pressure equipment.
- Step 1: Identify requirements
The directives and regulations propose different methods of proof of conformity. The choice depends on the product, its classification and its intended use. Each directive contains several basic requirements that the products must meet. They identify and increase the risks associated with the use of the product. If your product meets the EU standards that are subordinate to the directive, it is considered to be compliant with the EU directive. product tests are necessary in our own laboratories or by external bodies. They may also reasonably apply methods other than those proposed in the Directives to meet the essential requirements of some areas.
- Step 1: Compilation of technical documentation
The technical documentation contains all the information about the design, development and manufacture of the product. It is also referred to as a technical design file or technical file/dossier and contains at least:
- drawings and photos
- circuit diagram (optional)
- design calculations
- Technical description / product analysis
- bill of materials
- supplier declarations (optional)
- Audit logs and reports (optional)
- Instructions and user information
The technical documentation can be in any format, whether electronic or paper. They must be kept for ten years after the last unit is made.
- Step 2: If necessary, examination and approval by a notified body
If step 1 shows that this step is necessary for your product, a third party will be consulted for verification. For some products, such as fire alarm systems and invasive medical devices, the use of a third party is mandatory. The notified body shall verify that the product meets all technical and documentary requirements.
- Step 1: Declaration of conformity and CE marking
They prepare a declaration of conformity stating that the products meet all the necessary legal requirements and enclose them in the technical documentation. They affix the CE mark indelibly, legibly and visibly. In addition, if a notified body is involved in the CE certification process, the identification number assigned by the notified body will also be affixed to the product and user information.
What are VDE certifications?
The VDE Institute tests your product and, if necessary, the production site in accordance with international and national standards and issues a certificate. There are different VDE marks for different products, they have specific requirements. A VDE certification mark confirms that the product complies with harmonized standards. It also ensures that the product meets safety, health and quality requirements. The VDE mark is not required for CE marking.
How long does the conformity assessment procedure take?
The time taken to achieve CE conformity varies depending on the product type. On average, it is 4 - 6 weeks, but can be shorter or longer, depending on the manufacturer’s preparations. Mainly the type of product and the extent to which the product requirements comply with EU directives affect this period. Occasionally, products need to be adapted to the relevant directives as part of conformity assessment. In some cases, testing by an independent third party or notified body is required to ensure the safety of the products. If you would like more information, please contact us without obligation.
