Essentials of European Medical Device Regulatory Affairs

Conformity Assessment Procedures - Options

Custom made devices: • Annex XIII • Class III: + QMS (via Annex IX or Annex XI Part A)

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Conduct Risk Assessment

ISO 14971 Harmonised standard

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• 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 & post market. • EU specific requirements/deviations

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