Ecker, W. (2022). Performance Evaluation and Performance Studies of in Vitro Diagnostic Medical Devices Under the IVDR. In: Baumgartner, C., Harer , J., Schröttner, J. (eds) Medical Devices and In Vitro Diagnostics. Reference Series in Biomedical Engineering(). Springer, Cham. https://...
Performance Evaluation Report (PER) The performance evaluation report is an output of the process of performance evaluation activities populated from the results of applying the performance evaluation plan. Annex XIII, Part A (1.3.2) of the IVDR outlines the specific components of the PER ...
1IVDR,Article29(1) 2ThemanufacturershouldverifywhetherupdatesofitsPMPFevaluationreport(Article56(6))andtheperiodicsafety updatereport(PSUR,Article81(1))requirealsoanupdateoftheSSP. Page3of10 MedicalDevices MedicalDeviceCoordinationGroupDocumentMDCG2022-9Rev.1 added: Followingthisinformationthereisasummaryinten...
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