Journal
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
Volume 56, Issue 1, Pages 47-64Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s43441-021-00323-7
Keywords
Laboratory-developed tests; LDT; In-house IVD; IVDR; Validation; Conformity assessment
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Funding
- Projekt DEAL
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This study aimed to develop a regulatory strategy for compliance of laboratory-developed tests (LDTs) with EU IVDR requirements, taking into account international requirements. By reviewing regulatory literature and applying the strategy to a large medical laboratory in the EU, a four-step strategy for LDT compliance was implemented. Key criteria were identified for ensuring quality, safety, and performance of LDTs, with potential for future international consensus guidance.
Purpose This 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. Methods A 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. Results A 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. Conclusions This 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.
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