dRAST solution receives European CE Marking IVDR
- European in vitro diagnostic device CE-IVDR with enhanced safety and performance requirements
- Accelerated European and global market penetration with a solution that is two days faster than existing antimicrobial susceptibility tests.
The in vitro diagnostic medical device industry is in the midst of transitioning from CE-IVDD to CE-IVDR. The transition is essential as the CE-IVDR regulation comes into effect, and while passing the CE-IVDR has been challenging due to the COVID-19 pandemic and an overwhelming number of applicants, we were able to respond quickly to market requirements and obtain the CE-IVDR for its dRAST solution. We believe that the CE-IVDR will be a significant sales boost, as it will give them the perception that they are supplying a reliable product that has passed stringent European regulations.
"With the endorsement of CE-IVDR for dRAST, we plan to closely respond to the strengthened in vitro diagnostic medical device regulations in Europe and perfect the post-approval system," said Sung Hoon Kwon, CEO of QuantaMatrix. "We will accelerate our efforts to target the European market as well as other global markets that comply with CE-IVDR regulations."