Which item is required to demonstrate CE conformity?

Which item is required to demonstrate CE conformity?

• A. ISO 13485 certification
• B. Declaration of conformity
• C. Post-market surveillance
• D. CE assessment, technical documentation, declaration of conformity, and post-market surveillance

Answer: (D)

CE conformity is shown by a full conformity process tailored to the product, which includes performing the appropriate conformity assessment, assembling the complete technical documentation that demonstrates how the product meets the relevant requirements, issuing the Declaration of Conformity, and establishing post-market surveillance to monitor safety and performance after it’s on the market. ISO 13485 certification is a quality management system standard and can support the process, but it alone does not prove CE conformity. A Declaration of Conformity by itself lacks the technical evidence and the formal assessment path, and post-market surveillance by itself does not complete the initial conformity assessment. The combined set of conformity assessment, technical documentation, Declaration of Conformity, and post-market surveillance is what demonstrates CE conformity.

CE conformity is shown by a full conformity process tailored to the product, which includes performing the appropriate conformity assessment, assembling the complete technical documentation that demonstrates how the product meets the relevant requirements, issuing the Declaration of Conformity, and establishing post-market surveillance to monitor safety and performance after it’s on the market. ISO 13485 certification is a quality management system standard and can support the process, but it alone does not prove CE conformity. A Declaration of Conformity by itself lacks the technical evidence and the formal assessment path, and post-market surveillance by itself does not complete the initial conformity assessment. The combined set of conformity assessment, technical documentation, Declaration of Conformity, and post-market surveillance is what demonstrates CE conformity.