The specific process of CE certification usually involves multiple steps, and the following is a general overview of the process:
Confirm the product category:
Determine the product classification of the Brain Loop** to determine the applicable European directives and regulations.
Preparation of technical documentation:
Preparation of technical documents, including product design and manufacturing information, performance and safety assessments, test reports, instruction manuals, etc.
Select the Compliance Assessment Route
According to the risk level of the product, select the appropriate compliance assessment route. This may be a self-declaration of conformity or an assessment through an authorized assessment body.
Assessment and Audit:
Submission of technical documentation to the assessment body for document review and possible on-site audit. If self-declared, conduct an internal assessment.
Declaration of Compliance: For products that have been assessed by an assessment body, manufacturers are required to sign a Declaration of Compliance, declaring that the product complies with applicable European directives and standards.
CE mark attached:
For products that have passed the conformity assessment, the CE mark is affixed to the product to indicate that the product meets the regulatory requirements of Europe.
Registration: For some classes of medical devices, registration may be required in the medical device database of European countries or relevant institutions.
Establishment and maintenance of technical documentation:
Establish and continuously update technical documentation to ensure product compliance. This also includes timely documentation of any changes to the product.
Market Monitoring and Adverse Event Reporting:
Implement market monitoring and promptly report any adverse events that may affect product safety.