IVDR challenge: balancing regulation, innovation, and patient care
Prof. Dr. Christa Cobbaert presents:
- Release Date: 05.06.2026
- Duration: 22 minutes
- Guest: Prof. Dr. Christa Cobbaert
- Host: Director Global Medical & Clinical Affairs Ana-Maria Å imundiÄ
- Introduction: Recorded in midā2025, this episode explores IVDR challenges and the need for simplification, resulting in the EUās amendment proposal, which was published in December 2025 and will soon enter the legislative process.
Timestamps for Episode 2
- 0:18 ā Introduction and Christa Cobbaert's roles
- 1:49 ā IVDR history & unintended consequences
- 9:46 ā Advocacy efforts by BioMed Alliance and MedTech Europe
- 14:28 ā Expected path to "IVDR 2.0"
- 17:37 ā Precision diagnostics & P4 medicine
- 20:00 ā Most memorable preanalytical moment
- 22:16 ā Post-recording update
What You Can't Miss – In a Nutshell
IVDRās Historical Roots and Overshooting Regulation
- The episode explains how earlier legislation was too soft and why the new IVDR, though needed, became overly stringent and difficult for laboratories and manufacturers to implement.
Unintended Consequences for SMEs, Labs, and Patients
- Christa Cobbaert describes how especially SMEs providing specialty tests struggled under the regulationās stringency, resulting in disruption for laboratories and potential risks for patient care.
Missing Regulatory Pathways for Innovation and Rare Diseases
- The discussion highlights the absence of dedicated regulatory routes for breakthrough technologies and rare disease diagnostics, leading to delays and uncertainty across the diagnostic ecosystem.
āBoth for the MDR and for the IVDR we really have to organize ourselves ā you can name it lobby ā just to explain to the European Commissioners what was going on. ā
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Media owner: Greiner Bio-One GmbH, Bad Haller Str. 32, 4550 KremsmĆ¼nster, Austria
Christa Cobbaert served as corresponding author of this paper.
All MedTech Europe resources for targeted evaluation of IVDR and MDR can be accessed through this dedicated webpage.
The Future of EU Medical Technology Regulatory System - MedTech Europe
