Essentials of European Medical Device Regulatory Affairs - June 2020

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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Define intended purpose of the device

‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the labelling , in the instructions or in promotional or sales materials or statements and as specified… in the CER”

intended use indications contraindications warnings and precautions claims and benefits

who user

expertise

whom patient population where environment environment when concomitant compatibility

Align marketing materials with technical information and CER – Needs upfront agreement and documentation in the tech file – Needs approval process with regulatory review to prevent ‘drift’

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Establish Quality Management System (QMS)

EN ISO 13485 – the harmonised standard ● Framework for the policies, procedures, work

instructions, records etc., that are needed to bring your device to market. ● Includes regulatory requirements (vigilance, Field safety corrective actions (FSCA), risk management etc.) ● Needs to be assessed and certificated ● Watch out: – Ensure scope of QMS certification covers the devices you wish to CE mark – Ensure all activities are covered between yours, your suppliers and distributors certificates

TheOrganisation for Professionals in Regulatory Affairs

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