Table 8.

Phases of Performance Evaluation of LDTs as

Adapted from Annex XIII of the EU IVDR.

Phase of the performance evaluation	Title of the phase	Performance evaluation activities
Phase I	Planning of performance evaluation	Determination of the scope of the performance evaluation; description of the device under evaluation; assignment of responsibilities for the performance evaluation; selection of relevant performance criteria to generate the necessary clinical evidence for the LDT
Phase II	Execution of performance evaluation	Identification of the scientific validity and relevant analytical and clinical performance data
		Generation of data through performance studies, if applicable
		Appraisal of relevant performance data
		Assessment of relevant performance data
Phase III	Documentation of performance evaluation	Documentation of the results of performance evaluation
Phase IV	Update of performance evaluation	Post-market performance follow-up, if applicable