CE Mark is an abbreviation for Conformité Européene, which means European Conformity. Initially, it was EC Mark, but was replaced by CE Marking; it is now officially used in all EU official documents.
What is CE Marking Certification?
CE Mark is a regulatory and related Directive requirement specified by the European Union for products entering the European market. It ensures compliance with the requirements mentioned in the “official journal of the European Union”.
CE marking on a product demonstrates that the product has been assessed by the manufacturer and meets the EU safety, health and environment protection requirements.
Why is there a need for CE Marking certification?
CE Marking Certification acts as a trade passport for Manufacturers and importers looking to sell their products in the European Economic Area (EEA). It offers a manufacturer access to the markets of 30 countries that are part of the EEA. It embeds different laws, regulations and standards into a single framework and eliminates international trade barriers.
Benefits of CE Mark
CE Mark is not owned by any particular body, as the European Union makes the manufacturer responsible for its proper use. A manufacturer, whether established outside or inside the EU, can affix a CE Mark. If the manufacturer is established outside the EU, then s/he may appoint an authorised representative to act on his behalf established in the EU.
- Provides global access to your organization as products with CE Mark can be sold in the European Economic Area (EEA) without barriers.
- Ensures the same level of health, safety and environmental protection for the consumers.
- Leverages your organization and gives a competitive edge when it comes to acquiring new clients and partnerships.
- Enhances your organization’s reputation and boosts the confidence and trust of your customers.
- Increases the reliability and credibility of your organization.
Checklist for getting a CE Mark
Goods produced to supply and sell in the European market require a CE mark, but not all products need a CE Mark. The six steps checklist to get a CE Marking depends on your products, so:
- Identify the Directive that applies to your product.
- Make sure your product complies with the essential requirements of the Directive.
- Checking whether there is a need for an independent conformity assessment for your product.
- Test your product for conformity, including a risk assessment.
- Prepare and maintain all the technical documentation required by the Directive.
- Get your product CE Marked.
A step-by-step guide to get CE Marking Certification in India
The CE Marking process consists of six simple steps that all manufacturers, importers, and distributors need to follow. These are:
- Identify the Directive that applies to your product- There are around 20 product directives covering a vast range of products, but not all products are required CE Marking. Firstly, an organization needs to identify whether its product falls within the scope of at least one of the CE Marking Directives.
- Make sure your product complies with the essential requirements of the Directive– Each Directive defines the EU legal requirements that a product must meet. Each Directive extensively describes the conformities that entirely depend on the classification of the product. The CE Marking contains harmonized European norms (harmonized standards) and non-harmonized standards, also known as industry standards.
- Checking whether there is a need for an independent conformity assessment by a notified body for your product- Some products need to be tested and notified by the third party (notified body) to ensure conformity with the essential requirements. Products that need to be tested by the third party include medical devices, the ATEX Directive, the gas appliance Directive, and the pressure equipment Directive to ensure safety.
- The CE Marking process is the mostly self-declarative process a manufacturer must select the conformity assessment process from the available Directives of your product. The Directives use a series of questions related to the product’s nature to classify the levels of risk and refer to a chart called Conformity Assessment Procedure.
- Test your product for conformity, including a risk assessment- A manufacturer needs evidence to show compliance with the requirements.
There are 8 conformity assessment modules. These are:
-
- Module 1: Internal production control
- Module 2: EC type examination
- Module 3: Conformity of type
- Module 4: Production quality assurance
- Module 5: Product quality assurance
- Module 6: Product verification
- Module 7: Unit verification
- Module 8: Full quality assurance
- Prepare and have available all the technical documentation required by the Directive– All manufacturers must maintain the technical files or documents containing information to ensure compliance with the requirements of the Directive. The file needs to be kept for at least 10 years from the date of product manufacturing unless the Directive prescribes the date.
- Technical documentation contains the information in the following format:
- Extensive technical description of the product
- Designs, drawings, and photos to provide details of the product
- Bills of materials
- Conformity declaration and specifications
- Details of design calculations and a list of applicable harmonized standards
- Reports of assessments
- Copy of declaration
- CE marking your product- The last step is the Declaration of Conformity, which is a document certifying compliance with the CE Mark Directives and also an acknowledgement by the manufacturer to comply with the applicable directives. CE Mark is compulsory in all new products, even if the manufacturer is a member state or in a third country. In some cases, the Directive may exclude the application of CE Mark on certain products, but it varies from product to product.
Which Products need CE Marking?
CE Mark is required for products sold in the European Economic Area (EEA), including the European Union and Countries such as Switzerland and Turkey. It is mandatory for products that cover at least one of the New Approach Directives. Products that require CE Marking are:
- Hot-water boilers
- Household refrigerator and freezers
- Medical devices
- Machinery
- Lifts
- Toys
- Electrical equipment
