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
Molenkamp, Richard Presser, Lance D Baize, Sylvain Pannetier, Delphine Reusken, Chantal Bem Drosten, Christian Koopmans, Marion
Molenkamp, Richard
Presser, Lance D
Baize, Sylvain
Pannetier, Delphine
Reusken, Chantal Bem
Drosten, Christian
Koopmans, Marion
Series / Report no.
Open Access
Type
Journal Article
Article
Article
Language
en
Date of publication
2026-01
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
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
Translated Title
Published in
Euro Surveill 2026; 31(2):2500553
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.