1. Pre-analytical processes in medical diagnostics: New regulatory requirements and standards
- Author
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Uwe Oelmueller, Ulrike Schröder, Penelope Kungl, Karl-Friedrich Becker, Pamela Pinzani, Robert Sjöback, Andrea Wutte, Serena Bonin, Cornelia Stumptner, Georges Dagher, Paola Turano, Mikael Kubista, Peter Riegman, Stefania Gelmini, Helen C. Parkes, Carole A. Foy, Kurt Zatloukal, Pathology, Dagher, G, Becker, K-Friedrich, Bonin, S, Foy, C, Gelmini, S, Kubista, M, Kungl, P, Oelmueller, U, Parkes, H, Pinzani, P, Riegman, P, Schro ̈der, U, Stumptner, C, Turano, P, Sjo, ̈ back R, Wutte, A, and Zatloukal, K
- Subjects
0106 biological sciences ,in vitro diagnostic regulation ,molecular diagnostics ,in vitro diagnostic ,medical device ,pre-analytics ,ISO standard ,CEN Technical Specification ,Standardization ,Computer science ,Pre-Analytical Phase ,Bioengineering ,Context (language use) ,Certification ,01 natural sciences ,03 medical and health sciences ,pre-analytic ,CEN technical specification ,In vitro diagnostic medical device ,In vitro diagnostic regulation ,Molecular diagnostics ,Pre-analytics ,010608 biotechnology ,Humans ,Relevance (information retrieval) ,Product (category theory) ,Molecular Biology ,Diagnostic Techniques and Procedures ,030304 developmental biology ,0303 health sciences ,Scope (project management) ,molecular diagnostic ,General Medicine ,Service provider ,Reference Standards ,3. Good health ,Social Control, Formal ,Workflow ,Risk analysis (engineering) ,Equipment and Supplies ,Biotechnology - Abstract
In May 2017, the European In Vitro Diagnostic Regulation (IVDR) entered into force and will apply to in vitro diagnostics from May 26th, 2022. This will have a major impact on the in vitro diagnostics (IVD) industry as all devices falling under the scope of the IVDR will require new or re-certification. It will also affect health institutions developing and using in-house devices. The IVDR also has implications with respect to product performance validation and verification including the pre-analytics of biological samples used by IVD developers and diagnostic service providers. In parallel to the IVDR, a series of standards on pre-analytical sample processing has been published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). These standards describe pre-analytical requirements for various types of analyses in various types of biospecimens. They are of relevance for IVD product developers in the context of (re)certification under the IVDR and to some extent also to devices manufactured and used only within health institutions. This review highlights the background and the rational for the pre-analytical standards. It describes the procedure that leads to these standards, the major implications of the standards and the requirements on pre-analytical workflows. In addition, it discusses the relationship between the standards and the IVDR.
- Published
- 2019