The ISO 15189-IVDR dilemma in medical laboratory practice

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.

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.

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.

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.