The Conformitè Europëenne (CE) Mark is defined as the European Union's (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer's declaration that products comply with the EU's New Approach Directives.
The CE mark is a Product Certification and it signals that the product meets the requirements of relevant European directives. It is mandatory for a wide product range sold within or exported to the European Country or market. Compliance of these standard or directive is mandatory.
The CE mark is a Product Certification and it signals that the product meets the requirements of relevant European directives. It is mandatory for a wide product range sold within or exported to the European Country or market. ... Compliance of these standard or directive is mandatory.
Six steps to get CE marking
Find the CE directive(s) that apply to your product
Know the essential requirements for your product
Determine if you need third-party certification
Assess product conformity
Create and maintain technical documentation
Declaration of Conformity & affixing the CE Mark
The manufacturer or the authorized representative can only affix CE marking.
The CE marking cannot be affixed on the product that doesn’t fall under the EU’s directives and regulations.
The CE marking shall be the only marking that attests to the product’s conformity with the relevant Community harmonization legislation’s applicable requirements providing for its affixing.
The appearance of the CE marking should not mislead concerned parties. The marking should be done as per the prerequisites mentioned in the EU’s legislation.
Member states are responsible for maintaining the integrity of the CE certification/marking. To do so, they need to deploy relevant penal provisions to counteract the cases of infringement. Those penalties will be imposed accordingly as per the felony’s intensity and implement the deterrent to avert unethical use of the CE logo.
The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EEA).
The great benefit for manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.
In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.
CE marking is the final stage of the conformity assessment process as specified in the relevant Directive for the product. The conformity assessment process (sometimes referred to as the CE marking process) is concerned with:
assessing the risks presented by a product throughout its lifecycle
meeting safety objectives by design and construction
taking account of the current best practice to ensure the safety for that product, known as the state of the art
in some cases the supply Directive will require the use of third parties who have been notified by an EU member state to the EU Commission (usually referred to as "Notified Bodies") to verify compliance
collecting and retaining information about the design, testing and construction process and the means by which the product complies with the essential requirements of all relevant product safety Directives in a technical file which in most cases must be kept for at least 10 years after the last product of the product line has been produced
declaring the product's conformity with all relevant product safety law by means of a document (the Declaration of Conformity), which in most cases must accompany the product down the supply chain to the end user
and the preparation and provision of comprehensive product User Instructions, in the language of the end user.
CE Directives & categories your product falls into:-
The European Union has a similar product classification system as the U.S.:
Before a medical device can be launched in the European Economic Area (EEA), it must receive a CE mark. The CE mark confirms that the medical device meets certain "essential requirements" of the European General Medical Devices Directive (i.e. that it is fit and safe for the intended purpose). It also shows that the medical device can be freely marketed anywhere in the EEA without further control.
CE marking is mandatory, even if the medical device was manufactured outside the EEA. It is the manufacturer's sole responsibility to obtain and place the CE mark on the product. If the product is imported from outside the EEA, then this responsibility falls to the importer within the community.
Placed on many categories of products, CE Marking is mandatory for machinery, electrical and electronic equipment, medical devices, hazardous location equipment, and other products. So if you are looking to sell an electronics product in the EU, you will need to apply a CE mark.
The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985
CE stands for Conformité Européenne (French), which means European conformity
CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product’s compliance with relevant requirements
With a CE mark, your product can be sold in the EU and in Iceland, Liechtenstein, and Norway
There are six steps to CE marking
Identify the relevant directives and standards,
Verify the product’s specific requirements,
Identify whether an independent conformity assessment (Notified Body) is necessary,
Create technical documentation,
Add CE mark to the product
CE marking is not evidence of compliance – your technical documentation/technical file is
The manufacturer or authorized representative must keep technical documentation for a number of years (the number is dependent on the product type) after the last product has been placed on the market
Each EU country is responsible to enforce CE marking, by banning products and levying fines for non-compliance
Unsafe products are shared in the EU a rapid alert system on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers
There is a very similar logo where the CE stands for Chinese Export or China Export – this has nothing to do with European conformity
Pre-testing early in the product development process can reduce cost and time to market
CE marking allows free movement and sale of goods throughout the European Economic Area. For you to grow your business and distribute your products in the European market, CE-marking is mandatory for many products. It is a self-declaration process that your product complies with the directives which may include EMC & wireless radio testing. Consult with E-certifications experts if you want to avail CE certification or explore more detail on the benefits of CE certification.
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