CE certification is a regulatory requirement for the sale of medical devices on the European Economic Area (EEA) market. CE certification ensures that products comply with European directives and standards to ensure their quality, safety, and performance. The following are the general CE marking process and steps:
Confirmation of applicable directives:
Identify applicable European directives, such as the Medical Device Directive (now superseded by the Medical Device Regulation (MDR) and the Medical Device Diagnostic Performance Directive (IVDR).
Classification of products: Classify the brain loop machine and determine the applicable risk category to determine the subsequent compliance process.
Preparation of technical documentation:
Preparation of technical documentation, including product design and manufacturing information, performance and safety assessments, test reports, instruction manuals, etc.
Select a qualified assessment route:
According to the characteristics and risk level of the product, select the appropriate compliance assessment route. This may include a self-declaration of conformity or an assessment through an authorised assessment body.
Compliance Assessment: If you choose to have an assessment through an assessment body, submit the technical documentation and be assessed by them. This may include document audits, on-site audits, and more.
Preparation of technical documentation:
Based on the results of the compliance assessment, the technical documentation that meets the requirements of CE certification is prepared.
Sign the Declaration of Compliance:
For products that have passed a self-declaration, manufacturers are required to sign a declaration of conformity, declaring that their products comply with applicable European directives and standards.
Affix the CE mark:
Affixing the CE mark to the product indicates that the product complies with the regulatory requirements of Europe.
Establishment of technical documentation archives:
Establish and maintain an archive of technical documentation for review by European regulators.