Impacts of European In Vitro Diagnostic Regulation (IVDR) - Molecular Pathologist, Spanish Academic Lab

A molecular biologist and director of a molecular pathology lab in a public healthcare organization in Catalonia, Spain, describes how the introduction of IVDR has significantly impacted their organization, prompting major changes in purchasing and personne l. A specialized IVDR unit has been established in the hospital to ensure readiness and compliance with the new regulations. This has resulted in a considerable amount of work, particularly in the molecular pathology lab. While the stakeholder acknowledges the challenges and complexities of implementing IVDR, including a substantial amount of paperwork and the need for reclassification of products, they also highlight its potential benefits. IVDR is expected to standardize IVD across Europe, ensuring that a ll medical devices and assay kits used on patients are validated , thereby enhancing patient safety. Despite the intensive work and changes already needed for implementation, t he organization aims to be fully compliant by the following year, ahead of the co untry's 2025 deadline