Essentials of European Medical Device Regulatory Affairs

Process (Conformity Assessment)

Definition: MDR article 2 (40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

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Process (Conformity Assessment)

1. Define intended purpose of the device 2. Classify device 

3. Establish Quality Management System (QMS) 4. Choose a conformity assessment procedure 5. Establish post market surveillance system 6. Conduct Risk Assessment 7. Prepare technical documentation (incl general safety and performance requirements ( GSPR ) checklist 8. Submit to NB if required and get CE certificate(s)

9. Register the device Electronic system 10. Sign the declaration of conformity 11. Place on the EC market

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