European Federation of Clinical Chemistry and Laboratory Medicine
EFLM
Clinical Chemistry and Laboratory Medicine is at the heart of modern healthcare, and plays a vital role in screening for disease, diagnosis, risk assessment, treatment selection, monitoring of therapy, prognosis and other aspects of clinical decision-making.
ID: 400550533169-85
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
3 Oct 2025
Feedback on the current IVDR and proposal for change on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) by their Committee European Regulatory Affairs chaired by Prof. Dr. Christa Cobbaert of its Division of Quality, Standards and Regulations, chaired by Prod. Dr. Marc Thelen In the current IVDR paragraph 9 on performance characteristics requires that calibrators and control materials have documented metrological traceability to higher order reference materials and reference measurement procedures. In practice however, that leaves room for results in patient materials to lack metrological traceability to reference materials and procedures. As a consequence that leads to possible differences in the result from patient samples between two IVD-CE marked IVDs even if both calibrator and control materials in those methods share metrological traceability to an identical reference material and/or method. In the light of the European Health Data Space (EHDS) this would lead to the dangerous risk of unrecognised clinical inequivalence of results produced with different IVD for the same meaurand, allowing health care provider to misinterpret the shifts and trends in results of their patients produced in different health care institutions with different IVDs. We therefore strongly recommend to extend the required documented metrological traceabilty of results in the IVDR to routine patient samples. This will bring the regulation in line with ISO-EN-17511:2021 which is already harmonised to the IVDR. This standard requires metrological traceability of results in routine patient samples to reference measurement procedures and reference materials of the highest available level in an unbroken chain of value transfer between methods and materials with proven commutability between methods used in each step of the value transfer. Below we suggest how the current requirement in 9.3 can updated to accommodate our concerns which will future proof the IVDR to make the EHDS more safe. We are available for any further help in the reformulation if required. Current 9.3. Where the performance of devices depends on the use of calibrators and/or control materials, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures and/or suitable reference materials of a higher metrological order. Where available, metrological traceability of values assigned to calibrators and control materials shall be assured to certified reference materials or reference measurement procedures. Proposed 9.3 Where the performance of devices depends on the use of calibrators and/or control materials, the metrological traceability of routine patient samples to reference measurement procedures and/or suitable reference materials of a higher metrological order shall be ensured by a documented unbroken metrological traceability chain in which the materials used for the value transfer in each step is commutable between the methods in the particular step. Where available, metrological traceability shall be assured to certified reference materials or reference measurement procedures.
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