Navigating the IVDR: Challenges, Opportunities, and a Path to Safer Diagnostics

Contributors

4Bases is a Swiss-based company specializing in the development, production, and commercialization of clinically validated diagnostic purpose reagent kits for somatic and germinal analyses in NGS. 4bases is ISO 13485:2021 certified, continuously developing new solutions and addressing evolving regulatory needs. Contact: info@4bases.ch. Learn more: www.4bases.ch

Platomics automates regulatory processes and connects IVD manufacturers and laboratories to accelerate compliance and enable innovation. The PlatoX® platform saves time, resources, and costs by digitalizing regulatory work on the basis of intelligent data, not docs Learn more: www.platomics.com

Veranex is a global medtech service provider, offering regulatory strategy, clinical development, and market access support. They help companies navigate complex regulatory landscapes, including IVDR, to accelerate certification and ensure compliance. Learn more: www.veranex.com

Saphetor is the creators of VarSome; a platform offering advanced variant interpretation tools for clinical diagnostics and research. Interested in an IVDR-certified solution for NGS analysis? Let us know!

What's Covered?

This white paper provides a detailed breakdown of the IVDR landscape, covering the biggest challenges and how to overcome them:

• Understanding the IVDR shift: What changed from IVDD and why it matters
• Notified body shortages and certification delays: How they impact market access and strategies to mitigate risks
• Article 5(5) Compliance requirements for In-House IVDs: What labs need to do to maintain compliance
• Economic and operational impact: How IVDR affects costs, resource planning, and business strategy
• EUDAMED and regulatory transparency: How the European Database on Medical Devices will improve compliance

IVDR 2.0