Specifies general requirements and provides guidance for the performance evaluation of in vitro diagnostic medical devices (IVD[GU1.1]). It addresses the planning, generation, appraisal, analysis, and reporting of evidence to demonstrate the scientific validity, analytical performance, and clinical performance of IVDs across the device life cycle, including pre-market and post-market phases.
This document is intended for use by manufacturers, regulatory authorities, conformity assessment bodies, and other stakeholders involved in the generation, assessment, or review of performance evaluation evidence for IVDs.
This document does not:
— apply to in-house manufactured tests (laboratory-developed tests) (See ISO 5649)
— apply to research-use-only products, or medical devices that are not IVDs;
— specify device-specific acceptance criteria;
— specify detailed requirements for the conduct of clinical performance studies (see ISO 20916).
— specify requirements for IVD quality or risk management systems.
NOTE: Regional or national regulations can include additional or different requirements.
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Registration number (WIID)
93316
Scope
Specifies general requirements and provides guidance for the performance evaluation of in vitro diagnostic medical devices (IVD[GU1.1]). It addresses the planning, generation, appraisal, analysis, and reporting of evidence to demonstrate the scientific validity, analytical performance, and clinical performance of IVDs across the device life cycle, including pre-market and post-market phases.
This document is intended for use by manufacturers, regulatory authorities, conformity assessment bodies, and other stakeholders involved in the generation, assessment, or review of performance evaluation evidence for IVDs.
This document does not:
— apply to in-house manufactured tests (laboratory-developed tests) (See ISO 5649)
— apply to research-use-only products, or medical devices that are not IVDs;
— specify device-specific acceptance criteria;
— specify detailed requirements for the conduct of clinical performance studies (see ISO 20916).
— specify requirements for IVD quality or risk management systems.
NOTE: Regional or national regulations can include additional or different requirements.
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