The regulatory landscape for in vitro diagnostic (IVD) devices in the European Union has evolved significantly with the introduction of the In Vitro Diagnostic Regulation (IVDR). To help clinical researchers, regulatory professionals, and IVD manufacturers navigate these complex requirements, Quanterix recently hosted the webinar ‘From Compliance to Success: How to Create Efficiency and Effectiveness in EU IVDR Readiness for Clinical Studies’. 

This insightful session brought together the Quanterix experts to discuss key strategies for ensuring compliance while optimizing operational efficiency in IVDR performance studies. Below, we highlight the most important takeaways from this discussion. 

The Shift from IVDD to IVDR: What You Need to Know  

One of the biggest changes in EU diagnostics regulation is the shift from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR). Since its enforcement in May 2022, IVDR has introduced more stringent performance evaluation requirements, including: 

• Expanded clinical evidence requirements for market authorization 
• More rigorous oversight from Notified Bodies 
• A greater emphasis on analytical and clinical performance studies 
• Stronger risk management and data security protocols 

When Are Performance Studies Required?  

During the webinar, our experts clarified the situations in which IVDR mandates performance studies, emphasizing that compliance begins with understanding the intended use and clinical purpose of the device. 

Under IVDR, a performance study is required when: 

• The device’s test results impact patient management or guide treatment decisions. 
• Additional invasive procedures are conducted as part of the study. 
• The device is classified as an Investigational IVD, requiring additional regulatory oversight. 

Aligning Performance Studies with Clinical Trials: A Strategic Advantage: One of the most valuable insights from the webinar was the importance of integrating performance studies with clinical trials to maximize efficiency. By aligning study protocols, companies can: 

• Ensure regulatory compliance by meeting both IVDR and drug trial requirements. 
• Improve data integrity with standardized collection and analysis methods. 
• Reduce development timelines by conducting clinical and performance studies in parallel. 
• Mitigate risks early, avoiding costly delays and regulatory pushback. 

How Quanterix Supports IVDR Readiness 

A key theme of the webinar was how Quanterix helps companies navigate IVDR compliance with efficiency and confidence. Through our Accelerator Laboratory Services, we provide end-to-end support for IVDR performance studies, including: 

• Regulatory-compliant clinical testing aligned with IVDR expectations. 
• Custom assay development optimized for sensitivity, specificity, and reproducibility. 
• Analytical and clinical validation ensuring performance criteria meet regulatory standards. 
• Comprehensive regulatory support, including study design, documentation, and submission preparation. 
• High-quality, scalable assay production for clinical and research applications. 

Estimated Timelines for IVDR Submissions 

A frequently asked question is: How long does the IVDR submission process take? 

While timelines vary by country, a typical IVDR performance study submission follows this general 12-month framework: 

• Months 1-6: Preparation of Submission Packages 
• Months 7-8: Submission and Validation Phase
• Months 9-10: Final Assessment and Decision 
• Months 11-12+: Substantial Modification, if needed 

By leveraging Quanterix’ existing regulatory documentation templates and relationships with local regulatory liaisons to navigate country-specific requirements, IVDR performance study submission timeline can be accelerated, allowing sponsors to initiate their clinical trial sooner.

Overcoming Challenges in IVDR Compliance 

The panel also discussed some of the most common challenges companies face in IVDR performance study execution, including: 

• Complex regulatory requirements that vary by country. 
• Increased documentation burdens for performance study submissions. 
• Tight deadlines requiring early engagement with regulatory teams. 
• Integration hurdles when aligning performance studies with clinical trials. 

Final Thoughts: Moving from Compliance to Success 

By partnering with Quanterix, companies can navigate IVDR with greater confidence, efficiency, and effectiveness, supporting a faster path to market approval while maintaining the highest standards of diagnostic accuracy and reliability. 

If you missed the live session, don’t worry! The full webinar recording is now available on demand. Watch it to gain deeper insights into IVDR requirements, performance study best practices, and strategies for success in clinical trials. 

• Watch the full webinar recording here

Have questions or need IVDR support? Reach out to Quanterix to learn how we can help streamline your IVDR compliance journey!

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