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Publications

Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities
Lubbers BR, Dombrink I, Kalina T, Hofmans M, Bruun MS, Stanworth SJ, Béné MC, Döhner K, Brüggemann M, Macintyre E, van Dongen JJM.…

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IVDR

As of May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect.

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Program

Saturday, June 15, 2024 - Presidential Session I

Conducting multinational RCTs in pregnancy to improve maternal health in thrombosis: it CAN be done   

Prof.  Saskia Middeldorp, The Netherlands

Targeting the epigenome in lymphoma 

Prof.

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SWG Grant-funded projects, 2024

In November and December of 2023, SWGs were invited to develop project ideas and apply for a 2024 SWG Grant. ApplicationsWe received 11 different applications from 9 SWGs. This was two more applications than we received in 2022.

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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…

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