WE HELP YOU TO GET CE MARKING
Fast. Without spending a fortune
1. Determine the CE Rules
Determine which European regulations and standards apply to your products.
2. Assess the CE Conformity
Find out how to do demonstrate CE compliance yourself, and how to leverage your suppliers’ CE certificates.
3. Grow your business
Get CE marking, get access to the European market and grow your business.
What makes CE Marking with us so different?
When it comes to CE marking, there are many service providers out there that want to sell their consulting, testing and certification services. Our ‘Six Step CE Marking Framework’ is aimed to help your company to take control of the CE marking process and to do as much of the assessments yourself, reduce the costs and reach results fast. In six steps, our clients determine the applicable CE rules, self-certify the conformity, prepare the required and stay informed about regulatory changes.
Our framework can be tailored to your specific needs. We offer personal consulting and coaching, online workshops and tools. Hundreds of companies have grown their businesses by using our Six‑Step CE Marking Framework.
Conduct CE self-certification with our Six Step Framework and Coaching
CE Marking: Your Definitive Guide
The CE mark is a key indicator (but not proof) of a product’s compliance with European Union (EU) health, safety and environmental protection directives and regulations.
If your product comes under the scope of a directive requiring CE marking you must ensure the product complies with the applicable requirements and affix the CE mark before placing it in the market in the European Economic Area (EEA) (see “Countries In Which The CE Marking Is Required” below for a description of the countries that are included in the EEA). This is equally valid if your product is manufactured outside the EEA. Second hand products from outside the EEA that are placed in the EEA market for the first time, also require CE marking.
Often the CE marking is described as a trade passport because it enables the free movement of products within the European market. According to EU legislation, the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark.
- you cannot affix the CE mark to products which are not covered by the relevant European directives;
- by affixing the CE marking, you take full responsibility for your product’s compliance with the requirements of the relevant directives;
- other markings may be affixed to the product as long as that such markings do not create confusion with the CE marking in form or meaning.
The CE mark is a marking that consist of the initials ‘CE’ in the following form:
There are no specific color requirements for the letters and background of the CE mark. In other words, it is not required to print the letters ‘CE’ in black against a white background. However, the color schemes for the foreground and background should be sufficiently complementary, so that the CE logo is clearly visible. The minimum dimension of the CE mark must be 5 mm in height. If the size is enlarged, the letters CE must be in proportion to the standard version as shown. Please find here example of the CE logo in different file formats: http://ec.europa.eu/enterprise/faq/ce-mark.htm The CE mark sometimes is accompanied by a four-digit number. This is a reference number of the Notified Body that has been involved in the conformity assessment process.
Products that require to be CE marked are:
- active implantable medical devices
- appliances burning gaseous fuels (gas appliances)
- cableway installations designed to carry persons
- energy related products
- electronics and active components
- equipment and protective systems intended for use in potentially explosive atmospheres (ATEX equipment)
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- low voltage equipment (electrical material)
- measuring instruments
- medical devices
- outdoor equipment producing noise
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- simple pressure vessels
The CE marking is not required for the following type of products, for example:
The list of countries in which CE marking is required
The CE marking is affixed on the aforementioned products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.
The CE marking is currently required in the following countries:
- Austria (since 1995)
- Bulgaria (since 2007)
- Croatia (since 2013)
- Czech Republic (since 2004)
- Cyprus (since 2004)
- Estonia (since 2004)
- Finland (since 1995)
- Hungary (since 2004)
- Latvia (since 2004)
- Lithuania (since 2004)
- Malta (since 2004)
- The Netherlands
- Poland (since 2004)
- Romania (since 2007)
- Slovakia (since 2004)
- Slovenia (since 2004)
- Sweden (since 1995)
The United Kingdom (Great Britain) leaves the European Union at 31 December 2020, and from that moment they will require products to bear the UKCA marking.
Switzerland is not a member of the European Union, but for some products it accepts the CE marking as a presumption of conformity with Swiss national technical regulations.
CE marking obligations
The following economic operators have obligations regarding CE marking:
- manufacturer (irrespective if located in our outside the EEA)
- authorised representative
- fulfilment service provider
Manufacturers and importers of products manufactured outside the European Union have the following obligations:
- carry out the conformity assessment, which means that the product must be ensured to comply with the requirements of the applicable European Union CE marking regulations;
- maintain and keep available a Technical File with technical documentation that proves the product conformity with the relevant EU regulations, directives and standards;
- drawing up and signing the EU Declaration of Conformity (DoC);
- affix the CE marking (and possible other conformity markings) to the product;
- ensure the product stays in conformity, even after design modifications or when regulations, directives or standards are amended;
- ensure that the production is well organised and procedures are in place to ensure consistency in the quality of the end product;
- refrain from making the product available if their is doubt about the product safety or (CE) conformity;
- cooperate with the market surveillance authorities from the EU Member States, and follow their instructions.
Authorised representatives may be mandated to perform some of the aforementioned tasks, but they can never take over the responsibility for product conformity.
Distributors and fulfilment service providers have the obligation to verify that the product bears the CE marking, and that the EU Declaration of Conformity and user instructions are available. They also are required to refrain from making the product available in case of doubt about the product safety and conformity.
Importers and distributors that place products in the EU market under their own (brand)name, are considered to have the same obligations as the manufacturer.
Overview of the European Union CE marking directives and regulations
Here is an overview of the main CE directives and regulations. The links will take you to a page with information about the specific directive.
- Machinery Directive – 2006/42/EC
- Low Voltage Directive – 2014/35/EU
- EMC Directive – 2014/30/EU
- Medical Devices Directive – 93/42/EEC
- Personal Protective Equipment Directive – 89/686/EEC
- Construction Products Regulation – Regulation (EU) No 305/2011
- Pressure Equipment Directive – 2014/68/EU
- RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
- Waste Electrical and Electronic Equipment Directive – 2012/19/EU
- ATEX Directive – 2014/34/EU
- Toy Directive – 2009/48/EC
- Radio Equipment Directive – 12014/53/EU
- Recreational Craft Directive – 94/25/EC
- Active Implantable Medical Devices Directive – 90/385/EEC
- Explosive for Civil Use Directive – 93/15/EEC
- Noise Emission in the Environment Directive – 2000/14/EC
- Gas Appliances Directive – 2009/142/EC
- Lifts Directive – 1995/16/EC
- Pyrotechnic Directive – 2007/23/EC
- Measuring Instruments Directive – 2004/22/EC
When a products bears the CE mark it has free access to the market. The EU Member States’ authorities are not allowed to have conditions for market access. However, that does not mean that the authorities have no right to investigate the product’s compliance. Not only can they investigate, but they can also take measures against infringements. These measures may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary.
Please note that there is not a single, European Union enforcement agency or service. Enforcement of CE marking legislation is performed by national market surveillance authorities of the EU Member States. Enforcement is done in accordance with their national laws and procedures. These national market surveillance authorities work together closely. They share information about non-compliant and unsafe products. They also coordinate their market surveillance campaigns. If a non-compliant CE marked product is discovered in one of the EU countries, all the other market surveillance authorities will be informed about it within 24 hours.
How to get CE marking for your products?
Despite what many people believe, a manufacture does not “get” the CE mark from a third party certification body or a European or national authority. The manufacturer affixes the CE marking in his own right and is allowed to do so when all requirements are fulfilled. A test or certification body may be involved in the process merely as a service provider. However, the body will not take over responsibility for CE compliance. Responsibility for CE compliance will always remain with the manufacturer (or private labeler).
The CE marking rules typically require the following steps to be fulfilled before the CE mark may be affixed:
- Define the intended purpose of the product
- Determine the applicable CE directives/regulations
There are more than 25 different CE marking directives and regulations for different products or product-aspects. Multiple directives/regulations can apply to a single product.
- Identify the relevant essential requirements from the applicable CE directives/regulations
The product must fulfil all relevant essential requirements.
- Identify the applicable European harmonized standards
European harmonised standards are standards that may be used to prove conformity with the essential requirements.
- Identify which requirements of the European harmonized standards apply to the product
Not every clause from the applicable standards may apply.
- Conduct and document the conformity assessment against the essential requirements and the requirements from the standards (this may entail visual inspection, testing etc.)
Conformity assessment may include testing, measurements, risk assessment, visual inspections, calculations etc.
- Provide the user with the information required to use the product safely
This typically entails a user manual or instructions for use, installation instruction, and warning labels.
- Ensure consistency of production, thus proving the assessed sample and the production are identical
- Compile a Technical File
All technical documentation that proves the product safety and conformity with all relevant requirements are brought together in the Technical File.
- Draw up and sign the EU Declaration of Conformity
For construction products a Declaration of Performance.
- Affix the CE marking
- Continuously monitor developments related to CE directives/regulations and European harmonized standards.
Apply new rules and amendments where appropriate.
CE Marking: Frequently Asked Questions
By affixing the CE marking to a product, the manufacturer indicates that the product has been checked and found to be in conformity with the applicable European Union product safety requirements requirements. The CE marking is sometimes referred to as a “trade passport” in the meaning that products that bear the CE marking are presumed to be in compliance and do not need to fulfil any other condition for free circulation in the European Union market.
No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU Declaration of Conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.
No. The CE marking is not a mark of origin. The CE marking only indicates that all EU requirements have been fulfilled when the product was manufactured. A product affixed with the CE marking may have been produced anywhere in the world.
CE marking is required for a great range of industrial and consumer equipment, medical devices and toys. A full list can be found here. The CE marking is not required for foodstuffs and feed, for cosmetics and for chemicals or pharmaceuticals. We will be glad to assist you to determine if your products require CE.
In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.
The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. In accordance with these national laws, and depending on the seriousness of the crime, economic operators may be punished for false CE marking with fines, prohibition of sales, product recalls or withdrawals and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to take the product off the market.
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