Despite good intentions, the regulation on in vitro diagnostic medical devices (IVDR) in Europe could impact negatively on preparedness and response for the next pandemic
Publication date
2026-01-15
Authors
Molenkamp, Richard
Presser, Lance D.
Baize, Sylvain
Pannetier, Delphine
Reusken, Chantal
Drosten, Christian
Koopmans, Marion
Editors
Advisors
Supervisors
Document Type
Article
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Abstract
Currently, there is concern and uncertainty in the European and North American markets for in vitro diagnostics regarding the regulation of in vitro diagnostic tests. In the European Union, starting from May 2022, the regulation on vitro diagnostic medical devices (IVDR) has replaced the directive on in vitro diagnostic medical devices (IVDD). The IVDR, while written with the good intentions to ensure patient safety and health while supporting innovation and transparency, has resulted in uncertainty, instances of disruption of diagnostic development, and concerns related to pandemic preparedness and response. We here outline the history, current situation and concerns regarding pandemic preparedness in Europe. Finally, we make recommendations that could improve the IVDR while supporting pandemic preparedness.
Keywords
diagnostic test, Europe, In Vitro Diagnostics Regulations, IVDR, pandemic, preparedness, Epidemiology, Microbiology, Immunology and Microbiology (miscellaneous), Public Health, Environmental and Occupational Health, Microbiology (medical), Virology, Infectious Diseases, SDG 3 - Good Health and Well-being
Citation
Molenkamp, R, Presser, L D, Baize, S, Pannetier, D, Reusken, C B, Drosten, C & Koopmans, M 2026, 'Despite good intentions, the regulation on in vitro diagnostic medical devices (IVDR) in Europe could impact negatively on preparedness and response for the next pandemic', Eurosurveillance, vol. 31, no. 2, pii=2500553. https://doi.org/10.2807/1560-7917.ES.2026.31.2.2500553