MDCG template for substantial modification of performance study

Performance evaluation data can derive from performance studies. Data generated in performance studies must be reliable and robust, as stated in the Regulation on IVD medical devices (IVDR). Additionally, it is crucial to protect the safety of subjects participating in such studies.

An additional template for performance studies

A performance study must have a sponsor. According to the IVDR definition, a sponsor means “any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study”.

Together with the required documentation, the sponsor submits the performance study application or the PMPF (Post Market Performance Follow-up) study notification to the Member State where the study is taking place. The sponsor shall notify the same Authority if they intend to perform modifications to the study which can have a significant impact on the subjects involved or on the data generated.

In addition to the templates provided in the previous document, the Medical Device Coordination Group (MDCG) provided:

  • Template for ‘Substantial modification of performance study under IVDR

The MDCG publishes such templates to use only in absence of the full functionality of EUDAMED. The last templates can be found here.

Check out all relevant documents in our Library of Documents.

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