Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0864. Online ahead of print.
ABSTRACT
INTRODUCTION: To analyse the structural and operational divergences between NF EN ISO 15189:2022 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the context of medical laboratory practice in Europe.
CONTENT: This article provides a structured comparative analysis of ISO 15189:2022 and the IVDR across key regulatory domains relevant to medical laboratories. The analysis focuses on legal scope, classification of in-house in vitro diagnostic devices, validation and performance evaluation requirements, quality management systems, risk management, traceability, and post-market surveillance. Particular attention is given to the implications of Article 5(5) IVDR governing health institution exemptions and its interaction with ISO 15189:2022 accreditation requirements. The comparison is based on a thematic framework synthesising regulatory texts, international standards, and interpretative guidance relevant to laboratory medicine practice.
SUMMARY: Although ISO 15189:2022 and the IVDR share the common objective of ensuring patient safety and diagnostic reliability, they are grounded in fundamentally different regulatory paradigms. ISO 15189:2022 is focused on healthcare service quality and laboratory competence, whereas the IVDR introduces a device-centric lifecycle approach. This divergence may result in overlapping or partially conflicting requirements, particularly for laboratories developing or modifying in-house diagnostic methods. In certain cases, laboratory activities compliant with ISO 15189:2022 may still fall within the scope of IVDR obligations.
OUTLOOK: Greater regulatory clarity and proportionate interpretation of IVDR requirements for health institution laboratories are needed to ensure both compliance feasibility and continued access to specialised and patient-specific diagnostic testing across Europe.
PMID:42504958 | DOI:10.1515/cclm-2026-0864