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
PDF deck with summarized feedback from stakeholders
Individual PDFs of call transcripts with stakeholders
This package includes both the PDF deck and transcripts, providing a comprehensive understanding of stakeholders' views. You will receive a summarized report in the form of a PDF deck, as well as the full transcript of the discussions.
Individual call transcript of a single stakeholder discussing their views. This option is ideal for those who are interested in a specific stakeholder's perspective and insights on the topic.