The Medical Devices Introductory Course 2020

BS EN ISO 14971: Overview of structure and contents

7.4 Benefit-risk analysis If a residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to determine if the benefits of the intended use outweigh this residual risk. If this evidence does not support the conclusion that the benefits outweigh this residual risk, then the manufacturer may consider modifying the medical device or its intended use (go back to 5.2). Otherwise, this risk remains unacceptable. If the benefits outweigh the residual risk, then proceed to 7.5

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

The effects of the risk control measures shall be reviewed with regard to: a) new hazards or hazardous situations are introduced; b) the estimated risks for previously identified hazardous situations are affected by the introduction of the risk control measures 7.5 Risks arising from risk control measures

Risk control option analysis (Clause 7.1)

Implementation of risk control measures (Clause 7.2)

Residual risk evaluation (Clause 7.3)

Benefit-risk analysis (Clause 7.4)

Risks arising from risk control measures (Clause 7.5)

Completeness of risk control (Clause 7.6)

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