Completion requirements
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1. Medical Device development and lifecycle management under the MDR and IVDR
1.5. Lifecycle management
Lifecycle management includes:
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- revisiting D&D (e.g., changes to the device or manufacturing process design)
- incorporating feedback from post market surveillance (PMS) and market surveillance
- incorporating new insights from e.g., complaints
- risk management, clinical evaluation processes and PMS will be interdependent and will be periodically updated.