Companion Diagnostic (IVDR)
IVD that is essential for the safe and effective use of a corresponding medicinal product to identify eligible patients or monitor treatment response.
Definition
Article 2(7) of the IVDR defines a companion diagnostic as a device essential for the safe and effective use of a corresponding medicinal product to (a) identify, before or during treatment, patients most likely to benefit, or (b) identify patients likely to be at increased risk of serious adverse reactions. Rule 3(c) of Annex VIII classifies companion diagnostics as Class C.What this means in practice
CDx conformity assessment requires a mandatory consultation between the notified body and the EMA (or a Member State competent authority) on the suitability of the device in relation to the medicinal product. This adds meaningful lead time versus a non-CDx Class C IVD and requires the manufacturer to align its evidence package with the drug label.- •Assuming a biomarker assay is a CDx only if the drug label names it. IVDR looks at the intended purpose claimed by the IVD manufacturer.
- •Underestimating the EMA consultation timeline in project plans.
- •Failing to coordinate label changes between pharma partner and IVD manufacturer, which can invalidate the CDx claim.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsThe ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).
The association of an analyte with a clinical condition or physiological state.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Article 2(7) and Article 48(5)VerifiedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2020-16 Rev.2 Guidance on ClassificationUncheckedMDCGhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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