Essentials of European Medical Device Regulatory Affairs - October 2019

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

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Conformity Assessment Procedures: Annex IX to XI

Annex IX • Based on QMS & Assessment of Technical Documentation – Chapter I (1-3): QMS – Chapter II (4-6): Technical documentation – Chapter III (7-8): Administrative provisions • QMS audit every 12 month (minimum) • QMS certificate • Significant changes to QMS /device range require approval • Additional requirements some devices: – Technical document certificate - class III and some IIb – Additional assessment processes for some devices (section 5)

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