New EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect

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On May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) came into effect, mandating stricter and more comprehensive certification and testing protocols for in vitro diagnostic medical devices. The IVDR, whose objective is to ensure that all marketed in vitro diagnostic devices (IVDs) are registered, traceable, safe, high-quality and performing, will have a major impact both on current commercially available IVDs (CE-IVDs) and in-house devices (IH-IVDs).

To address experts’ concerns that the IVDR would get national authorities, health institutions, notified bodies and industry unprepared, which would most certainly lead to shortages and disruption of care, the Council and the European Parliament adopted in December 2021 a European Commission proposal amending the IVDR implementation timelines.

EHA contributed to this achievement through widespread advocacy activity, engaging with EU authorities and aligning with fellow diagnostic disciplines via the BioMed Alliance and its EHA-led IVDR Taskforce. This BioMed Alliance IVDR Taskforce has recently published the article “Critical Implications of IVDR for Innovation in Diagnostics”, which addresses different elements around the IVDR implementation and its consequences for innovation and the work of laboratories. The article can be accessed on the HemaSphere journal website via the following link:

https://journals.lww.com/hemasphere/Fulltext/2022/06000/Critical_Implications_of_IVDR_for_Innovation_in.11.aspx

EHA is also raising awareness and continuously providing relevant and timely information on the IVDR to laboratory hematologists, clinicians and researchers. More information in the EHA IVDR webpage here: https://ehaweb.org/advocacy/ivdr/

Last Updated on Friday 03 June 2022.