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 . . .

 

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