Compliance with CE Marking Requirements for Medical Devices Workflow

CE Marking Application

Type: Fill Checklist

The CE Marking Application process involves several key steps: 1. **Initial Review**: The company reviews its product against the Essential Requirements of the EU's Low Voltage Directive (LVD), Machinery Directive (MD), or other relevant directives to determine if it meets the necessary criteria. 2. **CE Mark Calculation**: If the product meets the requirements, a CE mark calculation is performed to ensure compliance with the directive's technical specifications. 3. **Documentation and Testing**: The company must prepare all necessary documentation, including technical files and user manuals, and conduct testing and evaluation to verify conformity. 4. **Self-Certification**: Based on the results of the above steps, the company self-certifies its product, confirming it meets the relevant directive's requirements. 5. **EC Declaration of Conformity**: The company issues an EC declaration of conformity, stating that the product complies with the applicable EU directives and regulations. 6. **CE Mark Affixation**: The CE mark is affixed to the product or packaging, indicating compliance with EU safety standards. 7. **Record Keeping**: Companies must maintain records of the design, manufacture, testing, and evaluation of their products for at least 10 years after they are placed on the market.