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IVDR resources
IVD Taskforce Videos:Konstanze Döhner
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Monika Brüggemann
IVDR Sessions:
HemaSphere articles:
Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force
The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories
EU-Wide Access to…
Highlights from the SWG
Impactful activitiesSymposium at EHA2023The SWG held a symposium on ‘2. 0 diagnostics in hematology: the role of AI’ at the EHA2023 Congress. EHA2023 took place from June 8–11, 2023, in Frankfurt, Germany.
Read moreWhat to expect from European Affairs at EHA2024
European Affairs gives a voice to hematology professionals in Europe. The department ensures that the interests of EHA members are duly represented in policy, regulatory and scientific areas and networks.
Read moreClinical trials
The advance of highly innovative, increasingly personalized therapies in hematology requires novel clinical trial designs and more flexible, adaptive regulatory frameworks and improved data generation to support decision making both during and after clinical studies.
Read moreRegulation on Health Technology Assessment
The Regulation on Health Technology Assessment (HTAR) was proposed by the European Commission in 2018. It was formally adopted in December 2021 and will apply from January 2025.
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