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This research aims to evaluate the impact of the IVDR on pandemic preparedness and diagnostic development in Europe.

January 18, 2026EurosurveillanceOpen Access

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

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Analysis of IVDR regulations reveals negative effects on pandemic preparedness in Europe, suggesting improvements are necessary.

This research aims to evaluate the impact of the IVDR on pandemic preparedness and diagnostic development in Europe.
Reviewed the history of in vitro diagnostic regulations in Europe
Analyzed the effects of IVDR implementation from May 2022
Identified concerns regarding diagnostic disruptions and preparedness
IVDR has introduced uncertainties in the in vitro diagnostics market
Instances of disruption in diagnostic development have been observed
Concerns regarding the capacity for effective pandemic response have increased

Molenkamp et al. (2026) studied this question.

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