Roche Scores World's First CDx Certificate Under New EU Regulation

The companion diagnostic is a cancer biomarker assay used to identify patients most likely to benefit from a specific therapeutic treatment.

Amanda Pedersen

January 4, 2023

2 Min Read
vials of blood samples with label: cancer CDx
Image modified in Canva

Last year, Roche Diagnostics became the first manufacturer to score certification for a class D product under the new in vitro diagnostic regulation (IVDR) in the European Union. Now, Roche has scored the world's first CDx (companion diagnostics) certificate under the IVDR.

TÜV SÜD Product Service issued the certificate for Roche's companion diagnostics assay used to identify cancer patients who are most likely to benefit from a specific therapeutic treatment.

Companion diagnostics are key diagnostic tools to further enhance the emerging field of personalized medicine, TÜV SÜD noted. companion diagnostics are clinically validated to identify patient populations, allowing more individualized treatment based on a specific patient’s likelihood of response.

The IVDR introduced a new concept of risk classification for IVDs as well as a reorganization of the conformity assessment process. In general, the mandatory notified body involvement for IVDs to achieve a CE mark has increased significantly, from about 15% of IVDs with certification to the present level of more than 80% of IVDs.

While the EU Commission's new Medical Device Regulation (MDR) has drawn considerable criticism from industry, complying with the EU IVDR has been less burdensome than the diagnostics industry once feared it would be. In March 2022, RQM+, a regulatory consulting firm, published a paper highlighting synergies between the EU Commission's IVDR requirements and the requirements of FDA in the United States.

Previously, manufacturers could put companion diagnostics on the market without notified body involvement. Companion diagnostics are now classified as Class C and need to undergo a newly established conformity assessment in which the notified body is required to consult the respective competent authority (CA) for medicinal products according to the 2001/83/EC directive or the European Medicines Agency (EMA).

The involvement of an additional stakeholder – in the form of the EMA or the respective CA – increases the time needed for the overall notified body conformity assessment process, and this must be taken into consideration by companion diagnostic manufacturers, TÜV SÜD noted. The IVDR now requires Class C CDx products to be CE marked with the involvement of a notified body such as TÜV SÜD Product Service by May 2026.

More devices, fewer notified bodies

Introduction of the new risk-based classification system also means that manufacturers now have to involve a notified body in the approval of most IVDs, according to TÜV SÜD. The notified body acknowledged that the IVDR also establishes significantly stricter requirements for notified bodies, which now need to consult reference laboratories and other competent authorities. This extends the time taken up by conformity assessment processes.

These stricter requirements have had a negative impact on the number of available notified bodies in the EU. To prepare for the regulation, however, TÜV SÜD said it increased and qualified its resources over the last four to five years at a compound annual growth rate of nearly 20%.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like