Stage 1: Masks to determine the applicable directives CE" mark is a safety certification mark, is considered a passport for manufacturers to open and enter the European market. More and more Chinese companies will export their products to the EU at the same time, the EU has taken tougher economic measures on China, requiring China to be able to fully implement the commitments related to accession to the WTO, the product meets the requirements of the European Union CE marking
CE certification
The first step is to determine whether the product needs to be with the CE mark. Not all products must bear the CE marking, only those that fall within the scope of at least one sectoral directive requiring CE marking. There are more than 20 sectoral product directives that require CE marking, but they are not limited to products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.
To determine which directives may apply, as there may be more than one, simply read the scope of each directive to determine which one applies to the product (an example of the scope of the Low Voltage Directive is shown below). If the product does not fall within the scope of any of the sectoral directives, the product does not need to bear the CE marking (in fact, it must not bear the CE marking).
Stage 2: Determining the use requirements of the directives
Each directive has a slightly different method of demonstrating compliance, depending on the classification of the product and its intended use. Each directive has a number of "essential requirements" that must be met before a product can be placed on the market.
The best way to demonstrate that these essential requirements are met is to meet the requirements of a practical 'harmonized standard', which provides a presumption of conformity with the essential requirements, although use of the standard usually remains voluntary. Harmonized standards can be identified by searching for "official journals" on the European Commission's website, or by visiting the new methodology website set up by the European Commission and the European Free Trade Association in conjunction with the European Organization for Standardization.
Stage 3: Determining the appropriate route to compliance
While the process is always a self-declaration process, there are various "routes to certification" that can be integrated, depending on the directive and classification of the product. Some products (such as invasive medical devices, or fire alarm and suppression systems) may have mandatory requirements for the involvement of an authorized third party or "Notified Body" to some extent.
There are various ways to demonstrate this, including: manufacturer's evaluation of the product. Manufacturer's assessment of the product and the additional requirement for a mandatory factory production control audit by a third party. Evaluation by a third party (e.g. EC type testing) with the additional requirement of a mandatory factory production control audit by a third party.
Stage 4: Assessment of Product Conformity
When all the requirements have been established, the product needs to be assessed for compliance with the essential requirements of the Directive. This usually involves evaluation and/or testing, and may include assessing whether the product meets the harmonization criteria identified in step 2.
Stage 5: Compilation of Technical Documentation
The need to compile technical documentation, often referred to as Technical Documentation, relating to the product or range of products. This information should cover every aspect related to compliance and may include details of the design, development and manufacture of the product.
Technical documentation typically includes:
Technical description drawings, circuit diagrams and photographs bill of materials material specifications and applicable EU declarations of conformity for key components and materials details of any design calculations test reports and/or evaluation notes EU declarations of conformity may be supplied in any of the forms of technical documentation (i.e., paper or electronic). and must be kept for up to 10 years after the manufacture of the last unit and in most cases located in the European Economic Area (EEA).
Stage 6: Declaration and CE marking
The EU Declaration of Conformity must be completed when the manufacturer, importer or authorized representative is satisfied that the product complies with the applicable Directive or, for partially completed machines under the Machinery Directive, the ECU Declaration of Establishment.
CE certification