NEW YORK – MGI Tech said last week that it has signed the EU Declaration of Conformity for its DNBSeq-G99 sequencer, granting the instrument CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR).
According to an MGI spokesperson, DNBSeq-G99 has been classified as a Class A IVD device under IVDR, meaning it has "low patient and public health risk." As a result, the company can affix the CE mark to the instrument after signing the EU Declaration of Conformity without an independent assessment by a notified body.
With the CE mark in hand, MGI can now sell the DNBSeq-G99 in the EU and other regions that accept the designation.
First launched in China last year, the DNBSeq-G99 is a benchtop ultra-high-speed, low-to-mid throughput sequencer that promises 8 Gb to 48 Gb of data per run.
Last month, MGI unveiled the DNBSeq-G99 in the US through its Complete Genomics subsidiary at the Advances in Genome Biology and Technology (AGBT) annual meeting. The company said it plans to make the platform available in the US in the second quarter.