In December 2022, the Medical Device Coordination Group published various templates on performance study application and PMPF (Post Market Performance Follow-up) study notification.
Documents for performance study
When performing a study, the sponsor of the study should submit a notification or application to the Member state where conducting the study. In addition to the notification or application, the sponsor should also provide the documentation referred to in Chapter I of Annex XIV of Regulation on in vitro diagnostic medical devices (IVDR).
According . . .
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