OGT, a Sysmex Group company, announced that IVDR-certification has been granted for eight CytoCell fluorescence in situ hybridisation (FISH) probes designed for patient management in haematological cancers and prenatal conditions.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) replaced Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) on May 26, 2022. From this date, any new IVD products placed on the EU market must comply with the IVDR.
To avoid the anticipated backlog of IVDR conformity assessments, OGT committed early to IVDR and began discussions with a notified body, BSI, back in 2019, the company says. Since then, OGT has been working to be 100% IVDR-ready and to meet conformity requirements under the regulation. The culmination of this work has led to the certification of its first tranche of eight existing FISH probes as Class C devices under the IVDR, with further products to follow.
Being IVDR-compliant and already having products certified will also help to future-proof customer supply chains—adoption of OGT’s products will avoid the need to change suppliers and revalidate if IVDR products are not available from other companies.
“IVDR is all about patient safety and effectiveness, and at OGT, we’re really committed to compliance with changing worldwide regulations and providing products that meet these needs, for clinicians and patients alike,” says Steve Chatters, executive VP of Regulatory, Medical and Quality Affairs at OGT. “We have a great team that got us ahead of the game and in a rare position of not only being 100% IVDR-ready, but gaining certification for our first set of CytoCell FISH probes. This demonstrates that OGT means what it says and that our products live up to the claims. Our IVDR FISH probes are still the same trusted products that we’ve always had—the certification has further validated our quality, safety and effectiveness. These are products and a company you can depend on.”
OGT is in the final stages of commercialization, with launch anticipated early this year.
“I’m incredibly proud that OGT is the first FISH probe manufacturer to bring its probes to market under the new IVD Regulation,” says Adrian Smith, CEO of OGT. “Gaining IVDR certification is a challenging process. This achievement is a testament to the clinical efficacy and safety of our products, the dedication of our people and our unwavering commitment to quality.”