Essentials of European Medical Device Regulatory Affairs - June 2020

Conduct Risk Assessment • ISO 14971 Harmonised standard • Risks need to be eliminated or reduced risk as far as practicable • Any remaining residual risk must be outweighed by the benefits associated with the device – risk benefit analysis. • Risk Assessment required throughout the product life cycle -Pre market AND post market. • EU specific requirements/deviations

TheOrganisation for Professionals in Regulatory Affairs

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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Conformity Assessment Procedures: Annex IX to XI Annex X

• Based on Type Examination • Assessment of the technical documentation • Assessment and testing of device – representative sample – Notified Body tests the device (or manufacturer) – Type examination certificate • Any changes to the device design require approval • Additional assessment processes for some devices (annex IX section 5)

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