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Mainz Biomed Successfully Completes Conformity Assessment to IVDR Achieving New Level of EU Regulatory Compliance
New and stringent EU regulation on in vitro diagnostic medical devices sets a higher standard of quality and safety for in vitro diagnostic (IVD) products and
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[{"type":"text","content":"New and stringent EU regulation on in vitro diagnostic medical devices sets a higher standard of quality and safety for in vitro diagnostic (IVD) products and manufacturer process\nBERKELEY, Calif. and MAINZ, Germany, June 01, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has successfully completed the conformity assessment of its internal processes to In Vitro Diagnostic Devices Regulation (IVDR) compliance which becomes mandatory from May 26, 2022. Additionally, the ColoAlert patient kit is now CE marked to the IVDR requirements, a significant milestone and achievement for the company. The new, harmonized IVDR regulatory framework has been established to ensure the safety and performance of in-vitro diagnostic medical devices in the European market. Meeting conformity assessment requirements to IVDR compliance for ColoAlert, Mainz Biomed’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC), involves meeting new standards for the CE mark of its stool collection tool. “As a fast-growing organization and one looking to steadily unlock new global markets, it’s essential that we have watertight compliance across EU and other key jurisdictions,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The new IVDR framework is a major revision, focusing on patient safety and increasing the emphasis on the life-cycle management and continuous evaluation of products in the European market. While it significantly increases the regulatory burden for IVD manufacturers like ourselves, with the deep expertise of our team and existing sophistication of our internal processes and ColoAlert product, we’ve been able to successfully meet all the required criteria for compliance effectively and efficiently and in good time to meet the May 26th, 2022 deadline.” About ColoAlertColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IV...