European Day for Organ, Tissue and Cell Donation: Safe testing for safer donations

European Day for Organ, Tissue and Cell Donation: Safe testing for safer donations The use of human organs, tissues, cells and other substances of human origin (SoHO) has transformed modern medicine, offering life-saving and life-changing treatments to patients around the world. A single donor can potentially save up to eight lives, while tissue donation can improve the lives of as many as 100 people. Organ, tissue and cell donations can help patients whose organs are damaged or failing, support the treatment of people living with blood cancers and other haematological conditions, help fulfil a person’s wish to have children and improve or save lives in many other ways. However, the demand for donated SoHO remains higher than the available supply, highlighting the continuing importance of donation.  When organs, tissues and cells are donated for transplantation, reliable testing is essential to assess their safety and reduce the risk of transmitting infections. The EU4Health project EURL-IVD.3 contributes to safer organ, tissue and cell donations by supporting harmonised testing and quality assurance of high-risk (class D) in vitro diagnostic devices (IVDs). These devices are used to detect infectious agents, help assess the safety of donated blood, organs, tissues and cells, and identify life-threatening infectious diseases  Under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746, class D IVDs are subject to rigorous conformity assessment (‘CE-marking’) procedures involving a notified body. For certain class D IVDs, where an EU Reference Laboratory (EURL) has been designated, the notified body must request the EURL to independently verify the performance of the IVD and confirm the claims of the manufacturer. EURLs also do batch testing of these devices to help ensure consistent performance and quality across production batches. The EURLs therefore provide an additional layer of specialised scientific and technical verification in the conformity assessment process required for CE-marking.   EURL-IVD.3 project supports these laboratories in working together to strengthen cooperation and promote consistent testing practices across the EU. It builds on past projects EURL-IVD.1 and EURL-IVD.2, also funded through the EU4Health Programme. By supporting a coordinated approach to assessing high-risk diagnostic tests, the project helps laboratories provide reliable and comparable assessments, contributing to the protection of patients who depend on donated organs, tissues and cells.  Learn more:  European Donation Day (EDD) - European Directorate for the Quality of Medicines & HealthCare  EU reference laboratories (EURLs) - Public Health - European Commission  Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices - Public Health  Regulation - 2017/746 - EN - IVD - EUR-Lex  Background     EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe.     HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and tenders from 2021 to 2027.