Performance evaluation (Annex XIII)
IVDR Art. 56 and Annex XIII. Performance evaluation for IVDs is the IVDR equivalent of clinical evaluation under MDR. It is mandatory for all IVD classes and must be maintained as a continuous lifecycle process.
IVDR Art. 56 and Annex XIII. Performance evaluation for IVDs is the IVDR equivalent of clinical evaluation under MDR. It is mandatory for all IVD classes and must be maintained as a continuous lifecycle process.