1. What is CE certification?CE certification is a mandatory mark required by the European Union (EU) to prove that the product meets the requirements of EU regulations and standards. It is one of the basic requirements for European market access. CE certification is not only a mark, but also indicates that the product has passed testing and evaluation and meets the technical specifications and safety standards of the EU market. Only products that meet CE certification standards can be legally sold and circulated in the EU market.2. What is the New Approach Directive?"New Approach Directives" are a series of regulations formulated by the European Union to regulate products sold in the EU market and ensure that products meet the technical requirements and safety standards of the EU.Simply put, the "New Approach Directives" formulate specific rules and procedures for companies to apply for CE certification.The following are the specific rules and procedures of the "New Approach Directives": 2.1 Compliance with basic requirements: According to the applicable "New Approach Directives", products must comply with the basic requirements specified therein, including safety, health, environmental protection and other aspects. Companies need to ensure that their product design, manufacturing and use meet these basic requirements.2.2 Conduct risk assessment: Enterprises need to conduct risk assessment, identify the potential hazards of products, and take appropriate measures to reduce or eliminate these hazards. Risk assessment needs to be conducted based on the characteristics and uses of the product, and continuous assessment should be conducted at all stages of product design and manufacturing.2.3 Prepare technical documents: Enterprises need to prepare technical documents, detailing the design, manufacturing and performance characteristics of the product, as well as evidence of compliance with the relevant requirements of the "New Approach Directive". Technical documents should include design documents, manufacturing process control documents, test reports, etc. 2.4 Comply with relevant standards: Enterprises need to ensure that their products comply with applicable European standards, which usually correspond to the requirements of the "New Approach Directive". By meeting the standards, it is proved that their products meet the technical requirements and safety standards of the European Union.2.5 Make a declaration of conformity: Enterprises need to make a declaration of conformity that meets the requirements, stating that the product complies with the requirements of the applicable "New Approach Directive" and bear the corresponding legal responsibilities. The declaration of conformity should contain basic information about the product, applicable directives, conformity assessment procedures, etc.2.6 Labeling and Documentation: Products that meet the requirements of CE certification should be affixed with the CE mark to prove that they comply with EU regulations and standards. In addition, relevant technical documents and declarations of conformity are required for review and supervision by regulatory agencies and market surveillance departments.European Commission official website "New Approach Directive" query URL: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en 3. Products must comply with directives when applying for CE certification 3.1 What are directives: Directives are regulatory documents issued by the European Union (EU) to regulate the free circulation and safety requirements of products in the European market. Directives set specific technical and safety requirements for different types of products to ensure that the products do not cause harm to human health, safety and the environment during use. Directives provide the legal basis and requirements for CE certification. Products must comply with applicable directives when applying for CE certification, and design, manufacture and test products in accordance with their requirements.