Proteomedix receives IVDR certification for Proclarix®
Zurich-Schlieren, Switzerland, October 18, 2022. Proteomedix, a Swiss diagnostics company committed to advance prostate cancer care, today announced that is has received IVDR certification for its prostate cancer diagnostic test Proclarix® from TÜV SÜD.
The new In Vitro Diagnostic Regulation (IVDR) recently replaced the IVD Directive. Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low risk) to class D (highest risk). Proclarix as class C was assessed by TÜV SÜD for conformity resulting in IVDR certification.
“We are extremely proud about the certification of Proclarix under the new IVDR demonstrating compliance to the highest quality standard currently in force for tests used in screening, diagnosis, or staging of cancer,” said Ralph Schiess, CSO and co-founder of Proteomedix and added: “Offering Proclarix as one of the first IVDR compliant cancer tests demonstrates our commitment to highest analytical and clinical performance.”
As the regulatory landscape evolves toward a lifecycle approach that emphasizes risk management, Proteomedix incorporated the risk-based processes throughout its business by integrating risk management into its quality management system.
Martin Rhiel, Head of Quality and Regulatory Affairs at Proteomedix commented: “The IVDR requirements impact the entire IVD lifecycle, from development through clinical investigations and regulatory approval through post-market surveillance. IVD manufacturers must demonstrate proper technical documentation, conformity assessments, quality management requirements and post-market surveillance for ensuring continued safety and performance.