Module 16 2024

17/10/2024

The post market surveillance plan

Complaint handling procedure – describes the processes for complaint management

Vigilance/reporting procedure – describes the processes for vigilance reporting

Risk-management procedure – describes the processes for risk assessing complaints

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The post market surveillance plan

5) Trend analysis and reporting processes:

Article 88 (Trend reporting)

Annex III, 1.1(a), Indent 3 - Information from trend reporting;

Annex III, 1.1(b), Indent 5 - Methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;

Complaint handling procedure – describes the processes for trending, including action thresholds

Vigilance/reporting procedure – describes the processes for vigilance reporting

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