Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics

Abstract

The article covers the performance characteristics of in vitro diagnostics (IVD) medical devices, the systematic approaches to specify the performance characteristics of IVD medical devices, the review of regulations with specified performance characteristics, and the methods of validation and conformity assessment of performance characteristics.

Keywords

• in vitro diagnostics medical devices
• ivd
• precision
• reproducibility
• blank sample
• blank
• analytical sensitivity
• measuring range
• analytical interference
• selectivity