Wednesday, June 22, 2022
Time: 10:00 - 16:30 hrs
Format: Online Webinar
Programme: The new IVD EU regulation (IDVR 2017/746) has major implications on the use, availability and associated costs of in vitro diagnostic tests. But on the other hand, it also builds in many ways new assurance points to improve and monitor the quality of our diagnostic services. The previous directive (IVDD 198/79/EC) exempted laboratory developed tests (LDTs / in-house IVD) from all requirements of an IVD. Under the IVDR, LDTs are subject to additional requirements and may only be used if no alternative CE IVD kit is available on the market. A justification for hospital exemption of the use of an IH-IVD has to be given. A European study shows that genetic diagnostics is largely based on tests developed in-house. All players in the field of medical genetics will have to comply with the new European Regulation on in vitro diagnostic medical devices (IVDR) by May 2022 (and for some parts May 2024 and May 2028).
To help laboratories prepare for the IVDR, including compliance with IVDR requirements for in-house devices, the ESHG is hosting a full-day webinar on IVDR, providing the basics and latest updates on implementation, as well as tips and tricks for working towards compliance.
During these webinar presentations we invite speakers from the EU Commission, Notified Bodies, Compent authorities, national IVDR working groups, lab people working on the implementation of the IVDR will share their knowledge and experience.
Who should attend: Clinical Scientists, Lab Technicians, Lab Managers, Quality Managers, Lab Directors, Bioinformaticians
Plus d'informations sur https://www.eshg.org/index.php?id=ivdrday
Programme et contact dans le document associé