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CE Marking (Notified)

About of Service

  • Purpose: The CE marking demonstrates that a product meets EU requirements for health, safety, environmental protection, and consumer protection. It signifies conformity with applicable EU directives or regulations, ensuring a high level of product quality and safety for consumers within the EEA.

  • Applicability: CE marking applies to a wide range of products sold or placed on the market within the EEA, including machinery, electrical and electronic equipment, medical devices, toys, construction products, personal protective equipment (PPE), and more.

  • Legal Basis: CE marking is mandatory for products covered by EU directives or regulations that require conformity assessment and the affixing of the CE mark as proof of compliance. These directives and regulations set out essential requirements that products must meet to obtain CE marking.

  • Conformity Assessment: The process of obtaining CE marking involves assessing the product's conformity with applicable requirements through conformity assessment procedures. These procedures may include testing, documentation review, quality management system assessment, and involvement of notified bodies where required.

  • Technical Documentation: Manufacturers must prepare and maintain technical documentation demonstrating compliance with applicable requirements. This documentation typically includes product specifications, test reports, risk assessments, instruction manuals, and declarations of conformity.

Uses and Benefits
  • Product Categories: CE marking applies to a wide range of products across various sectors, including machinery, electrical and electronic equipment, medical devices, toys, construction products, personal protective equipment (PPE), and more.
  • EU Directives and Regulations: CE marking is required for products covered by EU directives or regulations that specify the use of the CE mark as a declaration of conformity to applicable requirements. These directives and regulations set out essential health, safety, and environmental requirements that products must meet to obtain CE marking.
  • Essential Requirements: Products must meet essential requirements relevant to their category, such as safety, performance, health, and environmental protection. Compliance is typically demonstrated through conformity assessment procedures, including testing, documentation review, and quality management system assessment.
  • Conformity Assessment Modules: CE marking may require different conformity assessment modules depending on the type of product and its associated risks. These modules range from self-certification by the manufacturer to involvement of notified bodies for testing, inspection, or certification.
  • Technical Documentation: Manufacturers must prepare and maintain technical documentation demonstrating compliance with applicable requirements. This documentation typically includes product specifications, test reports, risk assessments, instruction manuals, and declarations of conformity.

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Charges Structure & Our Scope of Work

Additional Disclosure

1. CE Marking Details

  • Certificate Information: Details of the CE marking certificate, including the certificate number, the name of the notified body that issued it, and the scope of the certification.
  • Notified Body Information: Information about the notified body, including its name, address, and accreditation status.

2. Product Information

  • Product Description: Detailed description of the product covered by the CE marking, including technical specifications, model numbers, and intended use.
  • Compliance Specifications: Identification of the specific EU directives and harmonized standards that the product complies with, such as the Machinery Directive, Low Voltage Directive, or EMC Directive.

3. Compliance Documentation

  • Technical File: A comprehensive technical file containing all documentation related to the product’s design, manufacturing process, and conformity assessment. This includes:
    • Product design and manufacturing specifications
    • Test reports and certificates
    • Risk assessments and safety evaluations
    • Instructions for use and maintenance
  • Declaration of Conformity: A copy of the EU Declaration of Conformity, which states that the product meets the relevant EU regulations and standards.

4. Testing and Certification

  • Testing Reports: Documentation of testing conducted by accredited laboratories or notified bodies, including test results and compliance with relevant standards.
  • Certification Process: Details of the certification process undertaken by the notified body, including the assessment procedures and any corrective actions taken.

5. Product Marking and Labels

  • CE Marking: Information on how the CE mark is applied to the product, including placement, size, and visibility requirements.
  • Labels and Warnings: Details of any additional labels or warnings required by the relevant EU directives or regulations.

6. Manufacturer Information

  • Manufacturer Details: Contact information for the manufacturer, including name, address, and any other relevant identification details.
  • Authorized Representative: If applicable, details of the authorized representative within the EU responsible for ensuring compliance and communication with regulatory authorities.

7. Compliance Monitoring

  • Ongoing Compliance: Information on how ongoing compliance with EU regulations is maintained, including procedures for monitoring and addressing any non-compliance issues.
  • Periodic Reviews: Details on any periodic reviews or audits conducted to ensure continued adherence to CE marking requirements.

8. Regulatory Communication

  • Regulatory Authorities: Contact details for EU regulatory authorities or bodies responsible for oversight of CE marking and product compliance.
  • Notifications of Changes: Procedures for notifying regulatory authorities of significant changes to the product or its compliance status.

9. Risk Management

  • Risk Assessment: Documentation of risk assessments conducted to identify and mitigate potential hazards associated with the product.
  • Incident Reporting: Procedures for reporting any incidents or safety issues related to the product to the relevant authorities.

10. Market Surveillance

  • Market Surveillance Reports: Information on market surveillance activities, including any inspections or investigations related to the product’s compliance with CE marking requirements.
  • Recalls or Withdrawals: Details of any recalls or withdrawals of the product from the market, including reasons and actions taken.

Terms & Conditions

Documents & Detail Required

  • Official EU Websites: The European Commission's website offers comprehensive information on CE marking, including guidelines, directives, regulations, and technical documentation. You can visit the European Commission's website on Product Safety and Market Surveillance for details.

  • National Standards Bodies: National standards bodies in EU member states may provide guidance documents, standards, and resources related to CE marking. For example, the British Standards Institution (BSI) in the UK and the German Institute for Standardization (DIN) in Germany offer relevant materials.

  • Industry Associations: Industry associations and trade organizations may offer guidance and resources specific to certain sectors or product categories. These organizations often publish best practices, technical guides, and training materials related to CE marking compliance.

  • Notified Bodies: Notified bodies designated by EU member states for conformity assessment under specific directives or regulations may provide information on conformity assessment procedures, requirements, and documentation. Notified bodies' websites or contact information can be found through official directories.

  • Consultants and Legal Experts: Consulting firms, legal experts, and compliance specialists with expertise in CE marking and EU regulations may offer guidance, training, and documentation services to help manufacturers navigate the CE marking process and ensure compliance.

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FAQ'S

What is CE marking?

CE marking is a symbol that indicates a product's compliance with European Union (EU) regulations, allowing it to be legally sold within the European Economic Area (EEA).

What products require CE marking?

CE marking applies to a wide range of products sold within the EEA, including machinery, electrical and electronic equipment, medical devices, toys, construction products, and more.

Is CE marking mandatory?

CE marking is mandatory for products covered by EU directives or regulations that specify its use as a declaration of conformity to applicable requirements.

What are the benefits of CE marking?

CE marking facilitates the free movement of goods within the EEA by providing a common regulatory framework for product safety and compliance. It enhances consumer confidence, fosters fair competition, and promotes trade between EU member states.

How do I obtain CE marking for my product?

To obtain CE marking, manufacturers must assess their product's conformity with applicable EU requirements, including essential health, safety, and environmental requirements. This typically involves conformity assessment procedures such as testing, documentation review, and quality management system assessment.