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Update on Leica Biosystems Progress Toward In Vitro Diagnostics Regulation (IVDR) Compliance

Leica Biosystems is pleased to announce its latest update for In Vitro Diagnostics Regulation (IVDR) certification from the notified body BSI for the immunohistochemistry (IHC) portfolio.

The IVDR is a piece of European Union legislation that aims to ensure the safety and performance of in-vitro diagnostic medical devices on the European market. Prior to the May 2022 deadline for Class A medical devices, Leica Biosystems ensured that all its applicable products fully met the new regulation. These products are available for purchase.

In addition, the company has made its first 63 BOND Ready-to-Use antibody products available under the IVDR requirements, as well as enabling validated use upon the BOND-PRIME immunostainer.

Medical devices that fall under Classes B, C and D have deadlines in 2027, 2026, and 2025, respectively. The company is working toward compliance for its remaining products and has just achieved its first certification for a companion diagnostic, the Bond Oracle HER2 IHC System.

The Bond Oracle HER2 system is a fully automated assay to accurately determine HER2 oncoprotein status in breast cancer tissue, which can help a clinician assess whether the patient would respond well to a particular drug treatment.

“I am proud of the great work our many colleagues have done thus far on this project,” said Ronald Dunn, Vice President of Global Regulatory and Clinical Affairs at Leica Biosystems. “As we continue the IVDR transition, our goal is to maintain a seamless supply of high-quality, fully compliant products to our customers.”

All Leica Biosystems products that are to be maintained on market in Europe will be transitioned to be fully IVDR-compliant prior to the Class C deadline of May 2026.