Companion Diagnostic (CDx) Products: EU Regulations
A companion diagnostic is an in vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment. In vitro diagnostics (IVD) can be used alone or in combination with other devices and/or therapies, when used in combination with a therapeutic drug, they are referred as Companion Diagnostics (CDx).
CDx products are specifically intended to identify patients who are targeted for therapy and who have a previously identified disease or genetic risk. A new classification system for companion diagnostics is introduced by the In Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) along with the requirement to submit to conformity evaluation by a designated authority. The Regulation is effective from May 26, 2022, after a five-year transition period.
Topics covered in this Whitepaper include:
- Background and Objective of Companion Diagnostic (CDx)
- Role of EMA
- Overview of EU- Regulation IVDR 2017/746
- For CDx, in accordance with Annex IX, section 5.2 of Regulation (EU) 2017/746
- Practical recommendations
