Module 16 2024

17/10/2024

The post market surveillance plan

3) Risk management and benefit/risk processes:

The PMS plan shall cover…

Annex III, 1.1(b), Indent 3 - Suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit/risk analysis and of the risk management as referred to in Section 3 of Annex I;

Risk management procedure – describes the risk evaluation thresholds for acceptability

Clinical evaluation procedure – describes how benefit/risk is determined

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The post market surveillance plan

4) Complaint investigation and analysis processes:

Article 89 (Analysis of Serious Incidents)

Annex III, 1.1(a), Indent 1 - Information concerning serious incidents, including information from PSURs, and field safety corrective actions;

Annex III, 1.1(a), Indent 2 - Records referring to non-serious incidents and data on any undesirable side-effects;

Annex III, 1.1(a), Indent 5 - Information, including feedbacks and complaints, provided by users, distributors and importers; and

MDR Annex III, 1.1(b), Indent 4 - Effective and appropriate methods and tools to investigate complaints and analyses market-relate experience collected in the field;

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