Roche scores world’s first companion diagnostic certificate under new EU regulation

SWITZERLAND — Roche has received the first In Vitro Diagnostic Regulation (IVDR) certificate for a companion diagnostic (CDx), according to TÜV SÜD Product Service, the notified body that assessed the device.

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.

The IVDR certificate covers a test for expression of PD-L1, a biomarker that influences how likely a cancer patient is to respond to immune checkpoint inhibitors such as Merck & Co.’s Keytruda and Roche’s Tecentriq.

TÜV SÜD stated that companion diagnostics are critical diagnostic tools for furthering the emerging field of personalized medicine.

Companion diagnostics have been clinically validated to identify patient populations, allowing for more individualized treatment based on the likelihood of response of a specific patient.

The IVDR reorganized the conformity assessment process and introduced a new concept of risk classification for IVDs.

In general, the mandatory notified body involvement for IVDs to obtain a CE mark has increased significantly, from approximately 15% of IVDs with certification to more than 80% of IVDs today.

While the EU Commission’s new Medical Device Regulation (MDR) has received widespread criticism from the industry, compliance with the EU IVDR has proven to be less onerous than the diagnostics industry had feared.

RQM+, a regulatory consulting firm, published a paper in March 2022 highlighting synergies between the EU Commission’s IVDR requirements and the FDA’s requirements in the United States.

Previously, manufacturers could place companion diagnostics on the market without the involvement of a notified body.

Companion diagnostics are now classified as Class C and must go through a newly established conformity assessment in which the notified body must consult the respective competent authority (CA) for medicinal products under the 2001/83/EC directive or the European Medicines Agency (EMA).

The involvement of an additional stakeholder, such as the EMA or the respective CA, lengthens the overall notified body conformity assessment process, which must be considered by companion diagnostic manufacturers, according to TÜV SÜD.

The IVDR now requires Class C CDx products to be CE marked by a notified body, such as TÜV SÜD Product Service, by May 2026.

News of the companion diagnostic IVDR certificate arrived about five months after TÜV SÜD named Roche as the recipient of the first IVDR certificate for a Class D medical device.

Class D covers the highest-risk medical devices. Products in the class must complete a process involving notified bodies and EU reference laboratories to come to market under IVDR. Roche received the certificate for a COVID-19 antibody test.

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