Essentials of European Medical Device Regulatory Affairs

Module 5

• Conformity Assessment Process

• Specific Requirements

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Process (Conformity Assessment) 1. Define intended use of the device 2. Classify device 

3. Establish Quality Management System 4. Establish post market surveillance system 5. Choose a conformity assessment procedure  6. Conduct Risk Assessment 7. Prepare technical documentation (incl essential requirement (ER) checklist) 8. Submit to NB if required and get issued certificates 9. Sign the declaration of conformity 10. “Affix” the CE mark and place on the EC market 11. Register the Product (if necessary)

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