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. 


For further information, please contact:
Hilja Ibert, CEO
hilja.ibert@gentian.no
+47 919 05 242 (mobile)

Njaal Kind, CFO and COO
njaal.kind@gentian.no
+47 919 06 525 (mobile)
 
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.