Property defines if the Device corresponds to a device that has a role of Companion Diagnostic device or not.
"Companion diagnostic" means a device which is essential for the safe and effective use of a corresponding medicinal product to:
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.