Abstract
PurposeThis study aimed at the development of a regulatory strategy for compliance of laboratory-developed tests (LDTs) with requirements of the Regulation (EU) 2017/746 (“EU-IVDR”) under consideration of international requirements for LDTs as established in major regulatory regions. Furthermore, it was analysed in how far elements of current LDT regulation could qualify for an internationally harmonised concept ensuring quality, safety and performance of LDTs.MethodsA review of regulatory literature including legislation as well as guidance documents was performed. The regulatory strategy was adapted from international guidance concepts used for commercially marketed IVD. It was then applied to the example of a large medical laboratory in the EU. A high-level comparison was conducted to identify gaps and matches between the different international regulatory requirements for LDTs.ResultsA four-step strategy for compliance of LDTs with the EU IVDR was implemented in an exemplary medical laboratory. On the basis of an internationally used LDT definition, LDTs constitute nearly 50% of the total IVD devices used in the laboratory. While an ISO 15189-compliant QMS is a major component, it should be accompanied by the application of appropriate processes for risk management, performance evaluation and continuous monitoring of LDTs. At least six criteria represent common characteristics of a potential, internationally convergent concept for the regulation/standardization of LDTs.ConclusionsThis study confirms the impact of LDTs for individualized and innovative medical laboratory testing. Prerequisites for LDT use as especially given by the IVDR and missing interpretation in the EU with regard to the scope of LDT definition, the application of standards and the extent of documentation for LDTs currently lead to uncertainties for both laboratories and regulatory bodies responsible for LDT oversight. The characteristics identified as common criteria for ensuring quality, safety and performance of LDTs may be considered as central elements of future international consensus guidance.
Highlights
Laboratory developed tests (LDTs) or “in-house in vitro diagnostic medical devices (IVD)” are broadly used in medical laboratories
While the European Union (EU) IVDR according to Article 2 largely follows the international consensus with regard to the general definition of IVD [25, 28], it is of note
As Labor Berlin is accredited according to International Organization for Standardization (ISO) 15189 and has a full quality management system (QMS) in place, the strategy presented in this study does include a regulatory concept, and demonstrates how regulatory requirements for LDTs can be integrated into the quality framework of an accredited laboratory
Summary
Laboratory developed tests (LDTs) or “in-house IVD” are broadly used in medical laboratories. LDTs are in vitro diagnostic testing methods that are performed by using in vitro diagnostic medical devices (IVD) which are developed, manufactured, and used within a single health institution and its corresponding laboratory. They are not available on an industrial scale. The setting of quality, safety and performance requirements within a regulatory framework for LDTs is relevant and is expected to have a significant impact on both individual patient care and on public health and safety [3, 4]
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