CE marking is one of the statutory requirements for the sale of medical devices in the European market. The following are the steps for CE certification of the Emotional Scene Dynamic Training System under normal circumstances:
Confirm product classification: Find out which class of medical device your EOS training system belongs to and determine the applicable CE marking directives.
Choose the appropriate CE marking directive: Choose the appropriate CE marking directive based on the characteristics of the product, such as the Medical Device Directive (MDD) or the Medical Device Regulation (MDR).
Appointment of a certification body: Choose a certification body that is accredited in Europe and sign a contract with it. The certification body will be responsible for assessing whether your product meets the requirements of CE marking.
Conduct a risk analysis: Conduct a risk analysis of the product to identify potential hazards and implement appropriate control measures.
Preparation of technical documents: Preparation of detailed technical documents, including product design, performance specifications, manufacturing processes, quality control, and other information. Ensure that the documents comply with the requirements of the CE marking directive.
Performance Testing and Validation: Conduct the necessary performance testing and verification to ensure that the product meets the relevant standards and requirements.
Implement a quality management system: Establish and implement a quality management system in accordance with ISO 13485 or other applicable standards to ensure the quality and compliance of products.
Apply for CE marking: Submit the application for CE marking to the certification body, including technical files and other necessary documents.
Audit and Assessment: The certification body will conduct an audit and evaluation of the technical documentation, which may include document review, laboratory testing, on-site audit, etc.
Issuance of CE certificate: If the product passes the assessment, the certification body will issue a CE certificate, which certifies that the product complies with the regulations and requirements of the European market.
Development and updating of technical documentation: Continuous monitoring of product conformity and regular updating of technical documentation to ensure that products continue to meet the requirements of CE marking.