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IVD/CDx
Develop your IVD and companion diagnostics faster with our comprehensive solutions
Specialized IVD & CDx Development Expertise
Comprehensive support for every phase of IVD and CDx development, from early-stage biomarker identification and assay development to clinical trials and regulatory submissions. Our expertise ensures that your diagnostics are developed with precision and meet the highest regulatory standards, leading to broad patient access.
Global Market Access and Regulatory Leadership
Our IVD and CDx market access and regulatory acumen helps lead your product to patients, faster.
FAQs
How does the new IVDR impact the development and regulatory approval of IVD and CDx products?
The In Vitro Diagnostic Regulation (IVDR), which came into full effect in the EU in May 2022, significantly raises the requirements for IVD products, including companion diagnostics (CDx).
The IVDR introduces stricter classification rules, more rigorous clinical evidence requirements, and increased oversight from Notified Bodies. For IVD and CDx developers, this means preparing comprehensive clinical performance data and ensuring compliance with new labeling, documentation, and post-market surveillance obligations. We help you navigate the new IVDR requirements, ensuring your diagnostics meet these higher standards and achieve successful market access in the EU.
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Who decides the class of my device?
The classification of the device is decided by the legal manufacturer. If your Notified Body disagrees with your classification, they may consult their local Competent Authority. The Notified Body and the manufacturer’s Competent Authority may consult among themselves, if they are different. The MDCG will be involved in decisions of classification for borderline products.
Related Glossary
In Vitro Diagnostic Medical Device (IVDMD)
Incident for IVDMD (IVDR definition)
Notified Body
Post-Market Surveillance
Pre-Market Approval (PMA)
Pre-Market Notification (510(k))
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.