Help disseminate IVDR Questionnaire - Share with diagnostic laboratories in your network

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The new EU Regulation on in vitro diagnostic medical devices (IVDR) will come into full effect per May 26, 2022 and will have substantial consequences for diagnostic laboratories. This means that the transition to the IVDR needs to be prepared carefully, and it is EHA’s aim to support European hematology laboratories with this preparation to ensure continuity in laboratory diagnostics in 2022 and onward.

The European Hematology Association Taskforce on IVD, in collaboration with the BioMed Alliance Taskforce on IVD and with expertise from Professor Christa Cobbaert from the European Federation of Clinical Chemistry and Laboratory Medicine, has elaborated a questionnaire on the current use of different IVD tests in diagnostic laboratories. The objective of the questionnaire is to gain insight into the current situation for medical laboratories, in particular the degree of (un)preparedness of medical laboratories for the IVDR implementation, and to make an accurate assessment of the potential impact that the IVDR will have on diagnostic laboratories and their test menu.

We are collecting information to be able to represent diagnostic laboratories in the process of the IVDR implementation, e.g., by providing critical advice to the European Commission and national competent authorities. At the same time, their input will help the BioMed Alliance and its associated medical societies to provide relevant information on this important topic. With these actions, we hope to ensure a feasible transition timeline and continuity in laboratory diagnostics after May 2022.

We kindly ask diagnostic labs to fill in the new questionnaire on their current use of IVD tests and their preparations for the IVDR by September 8, 2021.

 

Fill in the questionnaire here: https://www.surveyrock.com/ts/O63E2O.

 

For more information contact Dr Bart Lubbers (b.r.lubbers@lumc.nl) or Dr Isabel Dombrink (isabel.Dombrink@uksh.de).

What does the new EU Regulation on In Vitro Diagnostic medical devices (IVDR) mean for you?

Last Updated on Friday 20 August 2021.