Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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IVDR Annex II, 4. General safety and performance requirements (GSPR’s), example table

The Organisation for Professionals in Regulatory Affairs

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‘Evidence of the "life-cycle management" concept must be provided, … from design to disposal, considering all the appropriate PMS data. Note that risk management documentation shall comprise all parts / components of a device. Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. The requirements also apply in case of outsourced processes.’

IVDR Annex II, Benefit risk analysis and risk management

The Organisation for Professionals in Regulatory Affairs

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