CE is a compulsory conformity marking for certain products sold within the European Countries. This marking make recognizable to product in European Countries.
The CE Marking is a product certification.
The CE marking declaration of is the manufacturer that the product is according to requirements of the applicable EC directives.
“CE” is short form of Conformité Européenne, meaning European Conformity.
Not every products is required CE registrations. Products which are interactive with some categories are required CE registrations.
Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. In order to self-certify, the Manufacturer must do several things:
1. Decide whether the product needs to have a CE marking. The product must conform to all Directives that apply to the product.
2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:
- Module A – Internal production control.
- Module B – EC type-examination.
- Module C – Conformity to type.
- Module D – Production quality assurance.
- Module E – Product quality assurance.
- Module F – Product verification.
- Module G – Unit verification.
- Module H – Full quality assurance.
- MACHINERY DIRECTIVE
- LOW VOLTAGE DIRECTIVE
- EMC DIRECTIVE
- MEDICAL DEVICES DIRECTIVE
- PERSONAL PROTECTIVE EQUIPMENT DIRECTIVE
- CONSTRUCTION PRODUCTS REGULATION
- PRESSURE EQUIPMENT DIRECTIVE
- ROHS – RESTRICTION OF HAZARDOUS SUBSTANCES – DIRECTIVE
- WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT DIRECTIVE
- ATEX DIRECTIVE
- TOY DIRECTIVE
- R & TTE DIRECTIVE
- RECREATIONAL CRAFT DIRECTIVE
- ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE
- EXPLOSIVE FOR CIVIL USE DIRECTIVE
- NOISE EMISSION IN THE ENVIRONMENT DIRECTIVE
- GAS APPLIANCES DIRECTIVE
- LIFTS DIRECTIVE
- PYROTECHNIC DIRECTIVE
- MEASURING INSTRUMENTS DIRECTIVE
Steps For Self Certification
Stage 1: Identify the applicable Directive(s)
The first step is to identify whether the product needs to bear CE marking or not. Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectoral directives requiring CE marking. There are more than 20 sectoral product directives requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.
Stage 2: Identify the applicable requirements of the Directive(s)
The best way to demonstrate that these essential requirements have been met is by meeting the requirements of an applicable ‘harmonised standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary. Harmonised standards can be identified by searching the ‘Official Journal’ on the European Commission’s website, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardisation Organisations.
Stage 3: Identify an appropriate route to conformity
The process is not always a self-declaration process, there are various ‘attestation routes’ to conformity depending on the Directive and classification of the product. Many products (such as invasive medical devices, or fire alarm and extinguisher systems, Pressure Equipment, Lifts etc.) in most cases, have a mandatory requirement for the involvement of an authorised third party e.g. a “notified body”.
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.
Stage 4: Assessment of the product’s conformity
When all of the requirements have been established, the conformity of the product to the essential requirements of the Directive(s) needs to be assessed. This usually involves assessment and/or testing, and may include an evaluation of the conformity of the product to the harmonised standard(s) identified in step 2.
Stage 5: Compile the technical documentation
Technical documentation, usually referred to as the technical file, 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 description
- Drawings, circuit diagrams and photos
- Bill of materials
- Specification and, where applicable, EU declaration of conformity for the critical components and materials used
- Details of any design calculations
- Test reports and/or assessments
- EU declaration of conformity
- 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).