CE marking correctly applied
You can affix the CE mark and sign the declaration of conformity without worries.
Willy Lebherz
Director & founder of easyCE GmbH
Declaration of conformity done!
Receive your CE declaration of conformity ready for signature.
Risk assessment completed!
CE mandatory risk analysis conducted.
Relevant directives & standards applied!
Your product evaluated against relevant directives and standards.
Technical documentation created!
Receive a pragmatic, user-friendly operating manual.
CE mark attached!
Simply affix the CE mark and you're done.
routines differ depending on your role CE marking
CE AS PRODUCER
The CE marking stands for "Conformité Européenne" and informs consumers that a product complies with mandatory EU directives. Products must bear the CE mark if they fall under a variety of directives and regulations, including those for machinery, outdoor noise, electrical equipment, radio equipment, hazardous substances in electronics, construction products, medical devices, In vitro diagnostics, pressure vessels, protection systems in hazardous areas, pyrotechnic objects, personal protective equipment, scales, measuring instruments, gas combustion equipment, toys, lifts, cable cars, pleasure boats and fertilizers. The CE mark indicates that the product has undergone a conformity assessment in accordance with the EU-wide health, environmental and safety standards, as defined in the relevant directives and regulations. These standards cover a wide range of products, including medical devices, toys, machinery, electrical equipment, personal protective equipment and construction products.
The experts at easyCE will be happy to help you place your products on the market and assess special cases. We are happy to support you with CE, UKCA and other marking.
FAQ
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.
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.
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 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 2: 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 3: 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 4: 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 5: 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.
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Approach to CE marking
Type and manner of support
Scope of support
Contact during project processing
Find the easiest way to obtain the CE mark
Abbreviated process for CE derived directly from CE
All-inclusive or modular – whatever you prefer
Personal contact with experts who take your wishes into account
other CE service providers
Often lacking in sound judgement and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in terms of support scope
Mostly personal contact
CE Software
Follows standardised process; special circumstances not taken into account
Double burden for you: software management + no support during processing
Only according to software scope and purchased modules
No contact
You want support that lightens your workload and doesn't create more work.
This is what successful projects look like
CE marking and conformity assessment of all life phases of a copper mining tunnel boring machine in Australia
easyCE supports the entire conformity assessment process including risk assessment up to the declaration of conformity ready for signature for all phases of the life cycle of a tunnelling machine for copper mining in Australia. The completely new concept of using multi-arm cutting heads required special attention during the process. In addition to the conventional regulations, special safety and technical requirements that apply in Australia were also taken into account.
RL & VO: MRL - 2006/30/EU, EMC - 2014/30/EU, Low voltage - 2014/35/EU, PED - 2014/68/EU, ATEX - 2014/34/EU
CE labelling of switch cabinets
easyCE supports the entire conformity assessment process, including risk assessment, right through to the declaration of conformity for control cabinets ready for signature. In particular, the requirements from the Machinery, EMC and Low Voltage Directives with regard to DIN EN 60204-1: 2019-06 and DIN EN IEC 61439-1: 2021-10 had to be observed. A checklist was also drawn up for the selection of components that must fulfil special requirements (supplier selection).
CE marking and declaration of conformity of a mobile satellite communication system
easyCE supports the entire conformity assessment procedure, including risk assessment in accordance with the EMC Directive, right up to the ready-to-sign declaration of conformity for a satellite communication system. The system ensures the redundant forwarding of TCP/IP data in order to send or receive it via two or more satellite antennas. The system is used wherever a mobile communication system needs to be set up quickly over long distances.
RL & VO: RED - 2014/53/EU, Low Voltage - 2014/35/EU, EMC - 2014/30/EU
CE marking and declaration of conformity for a 2D laser cutting system
easyCE supports the entire conformity assessment procedure for a 2D laser cutting system with automatic pallet changer. The entire safety concept, including the 2-beam light barrier, was coordinated for the laser cutting system, the performance level was determined, a product analysis was created and a risk assessment was carried out in accordance with EN ISO 12100. Special requirements result for the mechanical components of the traverse for the laser cutting head, but especially for the kinematics of the pallet changer and laser cutting head. The cutting process (laser class 4) inside the cabin is safely shielded from the operator by laser protection screens, additional safety devices and the complete enclosure: laser class 1 outside the machine.
Takes into account among others: 2006/42/EC, 2014/30/EU, DIN EN 60825-1 etc.
See more of our project references and success stories
Get CE-marking done in 3 simple steps
Step 1
Request expert opinion
Ask for our expert opinion free of charge and find out what is necessary for the CE marking of your product. Be prepared to describe your product in broad terms.
Step 2
Receive our offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We will be happy to explain necessary steps on the phone.
Step 3
We get it done
When you place an order, you will be assigned your own personal CE expert who will carry out your CE marking and accompany you throughout the entire process. Your expert will also be at your side after the CE marking has been successfully completed.
Get CE-marking done, worry-free
Trust the experts of product safety and conformity
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and conformity since 1995
- Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
- Master of measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity - especially CE-marking. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.
We know what you need to do to get CE-marking done, worry-free.