Industry data survey shows roadblocks persist to full transition to the IVD Regulation

Posted on 02.03.2023

In October 2022, MedTech Europe ran its latest survey to gather data from IVD manufacturers on the state of the IVDR regulatory infrastructure. The survey represents an estimated 75% market revenue coverage. The full report and its annex with visuals of the results may be read here.

The survey indicates that around 21% of today’s total IVD market is already certified under the IVDR. This represents a three-fold increase compared to July 2021. At the same time, there are significant challenges which must be addressed to ensure a successful transition by the May 2025, May 2026, and May 2027 regulatory deadlines.

To support the transition to the IVD Regulation for legacy and innovative IVDs alike, more work is needed to further build the infrastructure of the regulatory system, and to make conformity assessments shorter, more efficient, and more predictable.

For further information, please contact Iana Slobodeaniuc, Manager In Vitro Diagnostics