New EU In vitro Diagnostics Regulation (IVDR) and Companion Diagnostics

By: Dr Tina Amini, Medical Device Division Director

Publ. 2020-04-02

The companion diagnostics market is an emerging market and is anticipated to experience significant growth owing to increase in targeted therapies, rise in demand for personalised medicine with increase in awareness in emerging economies, discovery of new biomarkers for various conditions, and higher number of unmet needs for the treatment of cancer.

The EU IVDR which has a five-year transition period, with full entry coming into force on 26 May 2022, marks a significant change in the regulation of companion diagnostic devices (CDx) in the European Union.

Dr. Tina Amini, Director of Medical Device Division, NDA Group, explains companion diagnostics are an indispensable part of personalised medicine. From an initial start of a handful of oncology drugs with corresponding diagnostics, the field has expanded to include multiple therapeutic areas, and the number of combinations has grown significantly. Based on drugs in clinical trials, the rapid growth will likely continue for the foreseeable future.

Dr Amini further explains that the greater degree of regulation for CDx as the result of EU IVDR compared to the current regulatory paradigm in the EU will require careful planning and integration of regulatory applications for the therapy and its CDx, as both will be regulated in tandem.

Dr Amini states “Combined with the change in classification for CDx and the requirements for a performance evaluation that includes significant evidence of clinical performance, as well as interaction with notified bodies and the involvement of the national competent authorities for medicines (or the European Medicines Agency) regulating the therapy to which the CDx refers, there will be a significantly increased burden on manufacturers. At NDA, we have the regulatory and technical knowledge and can support companies through the entire process to ensure timely market access.”


Contact us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World

  • This field is for validation purposes and should be left unchanged.