The European Metrology Network TraceLabMed : coordinating activities of European NMIs/DIs and calibration laboratories in the field of laboratory Medicine

Abstract

Metrologically-based quality assessment (QA) of clinical laboratory testing for in vitro diagnostic devices (IVD) is now compulsory for meeting the new European In-Vitro Diagnostic Device Regulation (IVDR) 2017/746 which requires traceability of values assigned to calibrators and control materials. To support IVD manufacturers meet these requirements, EURAMET approved the establishment of the European Metrology Network on Traceability in Laboratory Medicine (EMN TLM). The EMN TLM brings together metrology institutes and stakeholders in this field, such as External Quality Assessement (EQA) providers, IVD manufacturers, clinicians, and regulators. The primary goals of the EMN TLM are to identify and prioritise stakeholder needs, coordinate the provision of metrological services, and foster the development of new standards. Serving as a central point of contact for calibration and reference laboratories as well as for IVD manufacturers, the EMN TLM helps to ensure the traceability of their procedures and IVDs to metrological reference points in compliance with the IVDR requirements. The main achievements of the Network so far include: 1. The development of a plan for a joint sustainable European metrology infrastructure for traceability in laboratory medicine that stimulates smart specialisation of European NMI facilities and services. It describes processes to promote a constructive dialogue between NMIs/DIs and stakeholders such as clinicians, medical associations, External Quality Assurance (EQA) providers, regulators and IVD manufacturers. 2. The creation of a coherent strategy for a joint European response to the need for establishing and verifying results metrological traceability in accordance with the IVD Regulation (EU) 2017/746. This accommodates the need for sufficient redundancy while avoiding unnecessary duplication of work. A demonstrator comparison has been organized to show the ability of EMN TLM members to provide a coordinated response. A web portal was created which serves as a single access point. In the future, it will direct customers’ requests for specific calibration services and reference materials to the service providers. 3. Through the organization of online surveys and input from key stakeholders (IFCC, EQA providers, IVD manufacturers, NMIs/DIs and calibration laboratories), a priority list measurands for which Reference Measurement Procedures, Certified Reference Materials and calibration services are urgently needed has been established. 4. A roadmap addressing the further development of the EMN both regarding timing and content of the activities and services offered has been established. This has been formalized by the preparation of a Stragegic Research Agenda. Broadening the scope of the activities may include but is not limited to a better coverage of molecular diagnostics and genomics. Other developments include enhenced engagement with (a) clinicians, to support the identification and quantification of novel biomarkers and the definition of more reliable clinical thresholds, (b) IVD manufacturers, to provide tools for the metrological validation of new assays in accordance with the IVDR, (c) emerging European NMIs/DIs or even non-EU countries, to organise knowledge transfer by provision of support and training such as staff exchange and the organisation of interlaboratory tests.