PMCF plan/outcome


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This really seems like a weird request and I would ask for clarification. Before that you probably should be sure that you can defend your approach but it sounds like you do.

My two cents
As stated in annex XIV "PMCF shall be understood to be a continuous process that updates the clinical evaluation".
Therefore, all activities (or not taking specific activities) listed in the PMCF should be justified based on the initial MDR CER. This interface is crucial.
For example, during the clinical evaluation process you may have identified that your device is used within another approach or in combination with devices not considered initially (both still within the intended purpose). The data did not yet allow any conclusions though. Now you may add activities to the PMCF plan to gather more data on these topics within the upcoming period.
A lot of devices will not have any specific topics to watch out for. In these cases I would state that the last clinical evaluation report did not result in specific topics to watch but that, of course, basic PMCF activities (e.g. update of the literature search, customer feedback, market data) will be conducted.
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