Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Step 2: Conduct

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Clinical Performance Study Plan (Annex XIII 2.3.2)

The clinical performance study plan (CPSP) defines the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study. It shall contain in particular the information as laid down below. If part of this information is submitted in a separate document, it shall be referenced in the CPSP. • (a) Identification of the clinical performance study and the CPSP by the single identification number.

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