Saphetor SA’s VarSome Clinical platform has received European CE mark approval, complying with the European Union’s In-Vitro Diagnostic Medical Devices Regulation (IVDR) (EU Regulation 2017/746). This certification, granted by the notified body TÜV SÜD, marks a pivotal milestone in the integration of Next Generation Sequencing (NGS) data analysis into routine clinical practice.
The IVDR, which became fully effective on May 26, 2022, supersedes the previous In-Vitro Diagnostic Medical Devices Directive (IVDD). It imposes stringent requirements for the classification, performance evaluation, and post-market surveillance of in-vitro diagnostic devices. VarSome Clinical’s IVDR certification assures compliance with these rigorous standards, underscoring its safety, performance, and reliability.
This approval highlights the maturity of NGS technology and its critical role in clinical settings. As clinical genomics shifts towards routine care, transparency and reproducible performance are essential. The certification also mandates that in-house tests, or Laboratory Developed Tests (LDTs), and Research Use Only (RUO) products adhere to IVDR standards, including quality management systems and General Safety & Performance Requirements (GSPR).
Andreas Massouras, CEO and Founder of Saphetor SA, emphasized the significance of this achievement: “The journey to IVDR certification has taken us more than two years, involving extensive planning and hard work. This sets a new standard for NGS diagnostic pipelines, ensuring patient safety through transparent and robust processes. Genomic data is increasingly impacting healthcare, making it crucial to meet established medical standards. We are proud to be among the first bioinformatics platforms awarded a CE mark under IVDR, advancing human health with our VarSome Clinical partners.”
Amélie Martinez, RAQA Director at Saphetor SA, added: “This certification rewards our efforts in meeting IVDR requirements, both in medical device documentation and our Quality Management System. We are proud to provide healthcare professionals and diagnostic labs with an IVDR-compliant device, reducing their workload for process validation and allowing them more time to care for patients.”