CE Certification | CE Marking:
Many products require CE Certification / CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
What is CE Certification / CE Marking:
The CE mark is a symbol that when affixed to a product indicates that it complies with the relevant EU legislation, which enables the free movement of products within the European market. The CE mark is affixed by a manufacturer, importer or authorized representative, who are required to ensure and make a declaration that the product complies.
CE Marking is compulsory and must be affixed before a product is placed (for sale or own use) on the market within the 28 member states of European Economic Area. Not all products are required to be CE marked, only products that fall within the scope of a European Directive that has requirements for a product to be CE marked. Where a product is required to be CE marked, there is a simple process to follow.
Why CE Certification / CE Marking:
- Compliance of these standard or directive is mandatory.
- It is a legal obligation on the part of the manufacturer or his agent to ensure compliance of the specified requirements.
What benefits it bring to business:
- It is a mandatory requirement for the products exporting to European countries;
- Compliance with CE marking increases customer safety and low product liability risks;
- Marking enhances product design;
- Marking helps in creating product and brand image.
CE Marking is a applicable to below products:
- Appliances Burning Gaseous Fuels;
- Cable way Installations to Carry Persons;
- Low Voltage Electrical Equipment;
- Construction Products;
- Equipment and Protective Systems for Used in Potentially Explosive Atmospheres;
- Explosives for Civil Uses;
- Hot Water Boilers;
- Measuring Instruments;
- Medical Devices;
- Active Implantable Medical Devices;
- In Vitro Diagnostic Medical Devices;
- Non-automatic Weighing Instruments;
- Radio Equipment & Telecommunications Terminal Equipment;
- Personal Protective Equipment;
- Simple Pressure Vessels;
- Pressure Equipment;
- Recreational Craft;
Steps to achieve CE marking:
Identify the applicable Directive(s)
The first step is to identify whether your product can be CE marked or not. Not all products are required to be CE Marked, only the products that fall within the scope of at least one of the CE Marking Directives. There are more than 20 product Directives & Regulations covering a range of products. Such products include (but not limited to) electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices, and construction products.
Identifying which Legislation may be applicable involves a simple exercise of reading the scope of each Directive/Regulation. You then need to apply the scope to your product to establish which ones applies. (An example of the scope of the Low Voltage Directive below). Don’t forget that there may be more than one Directive/Regulation that applies to your product! Remember, if your product does not fall within the scope of any of CE marking Directives, then your product does not need to be CE marked, but is likely to fall within the scope of other product Directive(s).
Identify the applicable requirements of the Directive(s)
Each Directive has slightly different methods of demonstrating conformity. This usually depends on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ which the product has to meet.
The best way to demonstrate that these essential requirements have been met is by meeting the requirements of applicable ‘harmonized European Norms’ (Standard) known as hENs. Standards may offer a presumption of conformity to the essential requirements of the applicable legislation. However, do not forget that the use of standards usually remains voluntary. hENs can be identified by searching the ‘official journal’ on the European Commission’s website.
Identify an appropriate route to conformity
The CE Marking process is always a self-declaration process however you may need to involve a third party. This is set out in the ‘system of attestation’ and will vary between Directive. Some products (such as invasive medical devices or fire alarm systems) may, to some extent, have a mandatory requirement for some involvement of an authorized third party.
There are various attestation routes which include:
- An assessment of the product by the manufacturer.
- An assessment of the product by the manufacturer, with additional requirement for mandatory factory production control audits to be carried out by a third party.
- An assessment by a third party (e.g. EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party.
Assessment of the product’s conformity
When all of the requirements have been established, you need evidence that the product meets the essential requirements of the Directive(s).
This usually involves some assessment and/or testing. It will often involve ensuring that the requirements of the applicable harmonised standard(s), which were identified in step 2, have been met.
Compile the technical documentation
Technical documentation relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product. Technical documentation may also be known as the Technical File or Technical Construction File.
Technical documentation will usually include:
- Technical description.
- Drawings, circuit diagrams and photos.
- Bill of materials.
- Specification and, where applicable, Declarations of Conformity for the critical components and materials used.
- Details of any design calculations.
- Test reports and/or assessments.
- Copy of the Declaration.
- Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA).
Make a Declaration and affix the CE Mark
When the manufacturer, importer or authorized representative is satisfied that their product conforms to the applicable CE Certification / CE Marking Directives, they must complete a Declaration. Under most Directives, it is known as the EU Declaration of Conformity but other terms exist. Such as Declaration of Incorporation for partly completed machinery and Declaration of Performance for construction products.
The requirements for the Declaration vary slightly, but will at least include:
- Name and address of the manufacturer.
- Details of the product (model, description, and serial number where applicable).
- List of CE Marking Directives and standards that have been applied.
- A statement declaring that the product complies with all of the relevant requirements.
- Signature, name and position of the responsible person.
- The date that the Declaration was signed.
- Details of the authorized representative within the EEA (where applicable).
- Additional Directive/standard specific requirements.
In all cases, except for the PPE Directive, all of the Directives can be declared on one Declaration. Once a Declaration has been completed, the final step is to affix the CE mark to the product. When this has been done and all of the other CE Marking requirements have been met, the product can then be legally placed on the EU market.