Dear All,
The BioMed Alliance Taskforce on IVD in collaboration with the European Haematology Association Taskforce on IVD, and with expertise from Prof. Christa Cobbaert from the European Federation of Clinical Chemistry and Laboratory Medicine, 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 would like to ask diagnostic laboratories in the EU to fill in a questionnaire on their current use of IVD tests and their preparations for the IVDR (the new EU regulation on in vitro diagnostic medical devices).
The BioMed Alliance is collecting this information 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 beyond May 2022.
Please return the questionnaire before September 8th, 2021, to Anne-Claire Cazottes: [email protected].
If you have any questions about filling in the questionnaire, please contact Dr. Bart Lubbers: [email protected] or Dr. Isabel Dombrink: [email protected]
Thank you in advance for your help!
Best regards,
Anne-Claire Cazottes
EU Public Affairs & Communication Assistant
Sq de Meeûs 29, 1000 Brussels – Belgium
@Biomedalliance
