MDCG templates for performance study application and PMPF study notification

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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