Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
In vitro diagnostics (IVDs) play a critical role in diagnosis, proper treatment decisions, and monitoring patient outcomes. The European Union’s new In Vitro Diagnostic Regulation (IVDR) introduces significant changes for IVD manufacturers, necessitating a comprehensive understanding of the regulatory approval requirements to market a product in Europe. The requirements now include clinical and scientific evidence to support the validity of the IVD, as has been standard for reviews of therapeutic products for many years. Manufacturers should familiarize themselves with the key regulatory changes and adhere to the transition timelines specified by the IVDR to ensure compliance and continued access to the European market for their IVDs.
Related Insights
Case Study
Speed meets strategy: Delivering a critical FDA 1572 package in just seven days
Sep 9, 2026
Blog
Actioning the commitment letter: The PDUFA VIII changes that matter most to sponsors
Aug 25, 2026
Blog
Data without borders: Assessing China-only evidence for EMA approval – insights from ex-EMA and seasoned subject matter experts
Aug 19, 2026
Blog
The Next Frontier of ADC Development: Navigating an Evolving Regulatory Landscape
Aug 12, 2026
Webinar
From APAC to Global: Designing Data that Travels
Jul 16, 2026
Blog
Regulatory submissions as a source of insight: How AI can amplify the value of our work
Jul 15, 2026
Blog
Accelerating first-in-human studies: Why the FDA’s Expedited IND pilot signals a new era for early development
Jul 6, 2026
CTB Blog
A credible global regulatory strategy is an early-phase imperative, not a late-stage commercial exercise
Jun 23, 2026
CTB Blog
Understanding FDA complete response letters: Why CMC readiness must become a strategic priority
Jun 18, 2026
Case Study
Case study: Repositioning first-in-human development at speed
Jun 8, 2026
Blog
Beyond participation: How EU HTA is turning patient and clinician engagement into evidence architecture
May 26, 2026
Playbook
JCA in the EU: A roadmap for health technology developers
May 15, 2026
Related Insights
Case Study
Speed meets strategy: Delivering a critical FDA 1572 package in just seven days
Sep 9, 2026
Blog
Actioning the commitment letter: The PDUFA VIII changes that matter most to sponsors
Aug 25, 2026
Blog
Data without borders: Assessing China-only evidence for EMA approval – insights from ex-EMA and seasoned subject matter experts
Aug 19, 2026
Blog
The Next Frontier of ADC Development: Navigating an Evolving Regulatory Landscape
Aug 12, 2026
Webinar
From APAC to Global: Designing Data that Travels
Jul 16, 2026
Blog
Regulatory submissions as a source of insight: How AI can amplify the value of our work
Jul 15, 2026
Blog
Accelerating first-in-human studies: Why the FDA’s Expedited IND pilot signals a new era for early development
Jul 6, 2026
CTB Blog
A credible global regulatory strategy is an early-phase imperative, not a late-stage commercial exercise
Jun 23, 2026
CTB Blog
Understanding FDA complete response letters: Why CMC readiness must become a strategic priority
Jun 18, 2026
Case Study
Case study: Repositioning first-in-human development at speed
Jun 8, 2026
Blog
Beyond participation: How EU HTA is turning patient and clinician engagement into evidence architecture
May 26, 2026
Playbook
JCA in the EU: A roadmap for health technology developers
May 15, 2026