Moss, 28 September 2022
Gentian Diagnosis ASA, a fast-growing developer and manufacturer of innovative and efficient diagnostics for better treatment decisions, is pleased to announce that the first products have been certified by TüV SÜD as complying with the European In-Vitro Diagnostic Regulation (IVDR), EU 2017/746. This certification granted by notified bodies such as TüV SÜD is required for in-vitro diagnostics products to continue being sold in the European Union. The extensive requirements of IVDR were adopted by the European Parliament in 2017 with gradual implementation from 26 May 2022.
Gentian has implemented the EU regulatory requirements in its systems and processes to ensure continuous compliance and made all necessary preparations to have the first products certified.
Commenting on the achievement, Anne-Mette Akre, VP Quality Assurance and Regulatory Affairs of Gentian Diagnostics says: “This is a very important milestone for us and an extraordinary team achievement to receive this IVDR certification. Since we have a commitment to deliver products of the highest standard and meet our customer needs, we are very proud to have received this certificate for our first products”.
The risk classification of products and involvement of a notified body in the regulatory procedures have been one of the major changes with the implementation of the IVDR. Under the 98/79/EC Directive, 80% of the products were classified as self-declared and the majority of these products will end up in a higher risk class under IVDR. This new regulation calls for additional performance assessments based on scientific, clinical and analytical data. It also improves traceability in the supply chain and establishes a proactive monitoring system for the early detection of issues in products already in circulation. Although the introduction of IVDR is a considerable regulatory burden for the industry, it aims to increase the protection of health for patients and users.
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About Gentian Diagnostics Gentian Diagnostics (OSE: GENT), founded in 2001, develops and manufactures high-quality, in vitro diagnostic reagents. Gentian’s expertise and focus lies within immunochemistry, specifically infections, inflammations, kidney failures and congestive heart failures. By converting existing and clinically relevant biomarkers to the most efficient automated, high-throughput analysers, the company contributes to saving costs and protecting life. Gentian is based in Moss, Norway, serving the global human and veterinary diagnostics markets through sales and representative offices in Sweden, USA and China. For more information, please visit www.gentian.com.