IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland

Coste, Alix T; Egli, Adrian; Schrenzel, Jacques; Nickel, Beatrice; Zbinden, Andrea; Lienhard, Reto; Dumoulin, Alexis; Risch, Martin; Greub, Gilbert

doi:10.3390/diagnostics13182910

Citations

Citation copied

Coste, A. T., Egli, A., Schrenzel, J., Nickel, B., Zbinden, A., Lienhard, R., Dumoulin, A., Risch, M., & Greub, G. (2023). IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland. Diagnostics, 13(18), 2910. https://doi.org/10.3390/diagnostics13182910

Abstract

IVDR regulation represents a major challenge for diagnostic microbiology laboratories. IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variety of samples submitted for analysis. The regular emergence of new pathogens (including Echovirus E-11, Adenovirus 41, Monkeypox virus, Alongshan virus, and Enterovirus D68, as recent examples in Europe in the post SARS-CoV-2 era) is another factor that makes IVDR regulation risky, because