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> CE marking process
CE marking process
Product Identification
Identify the product and its intended use.
Determine applicable EU directives and regulations.
Classify the product according to relevant categories.
Conformity Assessment
Select the appropriate conformity assessment procedure.
Conduct a risk assessment to identify potential hazards.
Gather technical documentation and create a technical file.
Perform necessary tests and evaluations to ensure compliance.
Declaration of Conformity
Prepare the EU Declaration of Conformity.
Include all relevant information such as product details, directives, and standards.
Ensure that the declaration is signed by an authorized representative.
Marking the Product
Affix the CE mark to the product in accordance with regulations.
Ensure the CE mark is visible, legible, and indelible.
Include any additional markings required by specific directives.
Post-Market Surveillance
Implement a post-market surveillance plan to monitor product performance.
Keep records of complaints and incidents related to the product.
Be prepared to take corrective actions if non-compliance is identified.
Documentation and Records
Maintain all documentation related to CE marking.
Ensure records are up-to-date and readily available for inspection.
Review and update the technical file as necessary to reflect changes in the product or regulations.
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