The varvis® Software: The First Genomics End-to-End Software Certified as IVDR Class C Device

ROSTOCK, Germany - June 3, 2024 - PRLog -- Limbus Medical Technologies, a medical device manufacturer and software development company based in Rostock, Germany, has successfully completed the conformity assessment by a notified body and obtained certification for its varvis® software under the new In-Vitro Diagnostic Regulation EU 2017/746 (IVDR) as a Class C device.

The IVDR, which replaced the previous directive (IVDD) in 2022, not only imposes updated and more stringent requirements on IVD devices, and software devices in particular, but it also introduces a new risk-based classification scheme. Under the IVDD, only 8% of all IVD devices were subject to an independent review by a notified body. Under IVDR, 80% of all IVD devices will be subject to such review. More importantly, IVDR now also specifically regulates laboratory developed tests (LDTs) (https://blog.limbus-medtec.com/the-ivdr-affects-how-genetic-testing-laboratories-can-operate-all-over-europe-c39749e8ef07). This has a significant impact on rapidly evolving disciplines such as genetic diagnostics, as devices used in this field are classified in the second highest risk class 'C' under IVDR.

While genetic diagnostics has rapidly become a powerful tool for many different medical specialties, the majority of devices involved in critical aspects of the process have remained labelled 'research-use only' (RUO), have not been classified properly as Class C, or have not yet completed the challenging conformity assessment by an independent notified body under IVDR.

"Since its inception in 2015 our cloud-based software solution has been developed in such a way and with the goal of quickly meeting the new regulatory requirements," says Ben Liesfeld, Managing Director of Limbus Medical Technologies. "This is a team effort, and the entire team must be aligned with such a goal. Reaching this milestone faster than anyone else proved that our strategy paid off."

Sonja Strunz, Head of Regulatory Affairs at Limbus, adds, "We have demonstrated that our software is a reliable solution for diagnostic laboratories that complies with the latest regulations." She goes on to say, "To our knowledge, the varvis® software is the first Class C software that covers the entire process from raw data to genomic variant classification. Both SNV/Indel and CNV analysis are covered by our IVDR certificate."

About varvis®
The varvis® software is a clinical decision support system developed by Limbus Medical Technologies GmbH, a medical device and software development company. The cloud-based genomics platform is tailored to support the entire NGS workflow, from raw data processing to genomic data management and variant interpretation. Automated CNV and SNV analysis is fully integrated into the NGS workflow and clinically validated for panels of all sizes, including WES and WGS.