A RISK BASED APPROACH FOR THE （基于风险的方法）.pdfVIP

P r e q u a l i f i c a t i o n T e a m A RISK BASED APPROACH FOR THE ASSESSMENT OF IN VITRO DIAGNOSTICS (IVDs) Prequalification of Diagnostics PQDx_152 v1 13.05.2014 Table of Contents 1. Introduction 3 2. Intended Audience and Scope 3 3. Definitions 3 4. Abbreviations 4 5. Risk Classification 5 6. Assessing IVDs – Critical Elements 7 7. Performance Evaluations and Lot Release Testing 12 8. Conclusion 13 9. References 13 Annex 1. GHTF Classification Rules (refer to GHTF/SG1/N045:2008 “Principles of In Vitro Diagnostic (IVD) Medical Devices Classification”) 14 PQDx_152 v1 13.05.2014 Page 2 of 17 1. Introduction In vitro diagnostic medical devices (IVDs) play a critical role in both individual health and public health. Individual patient management depends upon the availability of reliable and accurate IVDs for clinical decisions on diagnosis and treatment, as does screening of blood/blood products for transfusion and human organs/tissues for transplantation . Likewise, good quality IVDs for the detection of infectious agents, for example, are crucial to controlling their transmission and to the appropriate allocation of valuable and often limited resources (i.e. medicines, laboratory testing, clinical expertise). Therefore, incorrect test results carry with them the potential to have serious health consequences. For this reason, a growing number of authorities assess IVDs for quality, safety, and performance prior to acceptance for procurement (generally known as pre-market assessment) and following their placing on the market (generally referred to as post-market surveillance). W