Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

a physiological or pathological state

congenital physical or mental impairments

The specific information that is intended to be provided by the manufacturer in the context of

the predisposition to a medical condition or a disease

the determination of the safety and compatibility with potential recipients

the prediction of treatment response or reactions

the definition or monitoring of therapeutic measures

Specific information for what ?

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The Organisation for Professionals in Regulatory Affairs

The medical interpretation becomes more important

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‘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

- patients likely to be at increased risk for serious adverse reactions as a result of treatment with

the corresponding medicinal product

Class C / Classification Rule 3 (f) = Devices intended to be used as companion diagnostics

IVDR introduces a definition for Companion Diagnostics for the first time in the EU

The Organisation for Professionals in Regulatory Affairs

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