Module 16 2024

17/10/2024

The post market surveillance plan

10) Specific methods of PMS:

Identify any methods of PMS that are specific to the devices and not part of established procedures, for example enhanced monitoring in the case of Field Safety Corrective Actions or to verify the effectiveness of corrective actions, etc.

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The post market surveillance plan

11) PMCF plan:

Annex III, 1.1(a), Indent 4 - Relevant specialist or technical literature, databases, and/or registers; (PMCF Plan, general method, literature searches) Annex III, 1.1(a), Indent 6 - Publicly available information about similar medical devices (PMCF Plan, general method, literature searches) Annex III, 1.1(b), Indent 10 - A PMCF plan, as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable;

PMS Plan – Reference the PMCF plan and summarize the general and specific methods of PMCF

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