Impacts of European In Vitro Diagnostic Regulation (IVDR) - Head of Diagnostics, German Academic Medical Center

The head of a molecular diagnostics at a German academic research laboratory highlights the aims of IVDR to tighten regulation and monitoring of diagnostic assay production or usage. The stakeholder highlights how IVDR already influences their budget and overall lab work costs.They are skeptical towards the effectiveness of IVDR, suggesting that some notified bodies responsible for assessing compliance may lack the necessary expertise to scrutinize data correctly.While their organization has the freedom to choose the assays it uses, opting for a lab-developed test (LDT) instead of a commercially available IVDR-approved product requires extensive paperwork and validation to prove that the LDT’s performance is at least equal, if not superior, to available IVDR-approved assays.They prefer using LDTs due to in-house assays’ ability to detect a wider range of biomarkers relevant to their clinical trials. However, when anew technology or assay comes to the market, they expect to lean towards IVDR-cleared products for time-saving and cost-saving purposes. Despite this, they still emphasize the importance of validating any new test that enters their laboratory. Overall, the sentiment towardsIVDR is mixed. While it is recognized for its role in regulating and ensuring standardization of assays, there are concerns about its effectiveness and the burden it places on labs choosing to use LDTs.