Bremerhaven, April 2024 - The mir|detect GmbH provides the successful IVDR certification their M371-Test announced. The company thus officially fulfils all requirements of the European In Vitro Diagnostics Regulation (Regulation (EU) 2017/746 IVDR). The M371-Test is a CE-IVD-certified blood test for the precise and non-invasive detection of testicular cancer.
Important milestone for molecular diagnostics
Certification in accordance with the IVDR is considered one of the most demanding regulatory procedures in the European medical device market. It confirms that the M371-Test fulfils the highest standards in terms of quality, safety and clinical performance.
"The IVDR certification marks a decisive step in the development of mir|detect," said Dr Nina Winter, CEO at mir|detect. "It underlines our claim to offer laboratories and doctors a scientifically sound, reliable and compliant solution for the diagnosis of testicular cancer."
With the certification, the M371-Test The official authorisation for clinical use in the European Union. It ensures that the product fulfils the strictest requirements for clinical evidence, performance evaluation and quality management.
This counts mir|detect is one of the few companies in Europe to have successfully completed IVDR certification for a microRNA-based liquid biopsy test.
