CE Marking
CE Marking certificate helps to meet sales and quality objectives. CE Mark certificate opens the door for entry the product to Europe.
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.
Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.
If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the members states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Product Directives contains the “essential requirements” and/or “performance levels” and “Harmonized Standards” to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
CEN stands for European Committee for Standardization
Cenelec stands for European Committee for Electrotechnical Standardization
CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country
CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 30 countries)
CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities
Along with more directives’ becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market. However, many non-EU exporters are still unaware of or unsure about this fact and its impact on their business.
How Do You Benefit From CE Marking?
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.
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.
Additional benefits may include your product being made safer for end-users
Develop new EU markets more easily
When your products carry the CE Marking you will find that importers, distributors and sales agents will be easier to appoint as they do not have to deal with complex compliance regulations. They will not want to get involved with product certification which requires complex professional expertise. They will probably excel in marketing and sales, but are they equipped in handling regulatory and legal issues?
General principles of the CE marking
Only the manufacturer or his authorised representative shall affix the CE marking.
The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonization legislation, and shall not be affixed to any other product.
The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonization legislation providing for its affixing.
The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
Many products require CE marking before they can be sold in the ACS EU+ Iceland, Liechtenstein and Norway). The CE mark demonstrates that your product has been evaluated and meets the EU’s safety, health, and environmental protection requirements. It is valid for products manufactured inside and outside the EEA, which are then marketed in the EEA.
To place the CE marking on your product, you must create a technical file that demonstrates that your product answer to all European requirements. As the manufacturer of the product, you are solely responsible for the declaration of conformity with all the requirements. Once your product is CE marked, you may need to provide your distributors and/or importers with all supporting documents related to the product. CE marked
How to get the CE marking?
- Identify the EU requirements for your product
- Check if your product meets specific requirements
- Check whether your product has to be tested by a notified body
- Test your product
- Compile the technical file
- Place the CE marking and write a declaration of conformity
The guidelines often use a series of questions about the nature of their product to classify the risk level and refer to a table called “Conformity assessment procedures”. The table includes all acceptable options available for a manufacturer to certify their product and affix the CE marking.
Minimal risk
Options for products with minimum risk include self-certification when the manufacturer prepares a Declaration of Conformity and place the CE marking on your own product.
More risks
Many Directives require products/systems with major risks to be independently certified; this must be done by a “Body notified”. It is an organization designated by a member government and notified by the European Commission. The notified bodies serve independent testing laboratories and perform the steps indicated by the instructions. They must have the necessary qualifications to meet the test requirements set out in the guidelines. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any Member State of the European Union.
