Effect of new European Diagnostic regulations

Effect of new European Diagnostic regulations

Our panel discussed the upcoming changes in the new European in Vitro Diagnostics Regulations (IVDR) and the ramifications for different stakeholders. The IVDR will be fully applicable from May 2022, a new provision that is going to change the European regulatory environment by ensuring more stringent clinical data requirements, extended data management, complex conformity assessment procedures (particularly for high-risk tests) and introduction of product liability and penalties.

While there are short term challenges and limitations, these regulatory changes are a golden opportunity to put effective communications in place ensuring that unmet needs in clinical pathways are taken into consideration in research and biomarker development. This could lead to innovative solutions that provide better patient outcomes.


Key Speakers:


Prof. Christa Cobbaert is the head of the Department of Clinical Chemistry and Laboratory Medicine at Leiden University Medical Centre in the Netherlands. 

Prof. Christian Mueller is the director of the Cardiovascular Research Institution at University Hospital of Basel in Switzerland. 

Prof. Christian Zaugg is the head of clinical science at Roche Diagnostics Core Lab customer area and is representing the manufacturers perspective in this discussion.

Key facts
  • IVDR is becoming fully applicable from May 2022.
  • To ensure a successful transition to the new regulations and improve the quality and safety of in-vitro diagnostics, a call to action from the panel includes:
    • Being involved and aware of the upcoming changes.
    • Participating and bringing different perspectives to find the balance between regulation and quick availability of tests.
    • Using evidence to highlight the value and benefit of diagnostic solutions for the healthcare system and patients.