IVD Companion Diagnostics
Overview
A companion diagnostic (CDx) is an IVD that is essential for the safe and effective use of a corresponding medicinal product. CDx devices are subject to specific requirements under IVDO because their performance directly affects the therapeutic decision for a potentially high-risk medicinal product.
Classification
CDx devices are typically classified under IVDO classification Rule 3 — companion diagnostics that determine patient suitability for a specific treatment. The classification depends on the risk associated with the corresponding medicinal product and is typically List B or above.
Co-development
The Swiss regulatory approach to CDx co-development aligns with MDCG guidance. Key aspects:
- The CDx label must specifically reference the corresponding medicinal product(s)
- The NB assessing the CDx must consult with Swissmedic's drug division (or the drug regulatory authority for the corresponding medicinal product)
- Clinical performance data should ideally be generated alongside the clinical trials for the corresponding medicinal product
Simultaneous Authorisation
Where possible, CDx registration with Swissmedic should align with the medicinal product authorisation timeline. Swissmedic coordinates between its medical device and drug divisions for CDx assessments.
Official Sources
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