OXFORD, UK — Some eight CytoCell® fluorescence in situ hybridisation (FISH) probes, critical for patient management in hematological cancers and prenatal conditions, were recently awarded the in vitro diagnostic medical devices (IVDR) certification. Oxford Gene Technology IP Limited (OGT), a Sysmex Group company, is the first manufacturer of FISH probes to obtain the new IVDR certification—demonstrating continued safety, reliability, and effectiveness under this substantially more stringent regulation.
ssssssRegulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) replaced Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) on 26 May, 2022. Per this, any new IVD products placed on the EU market after May 2022 must comply with the IVDR.
The IVDR certification means that customers can be confident in the continued quality, safety, and performance of OGT’s products and manufacturing processes. Being IVDR-compliant and already having products certified will also help to future-proof customer supply chains—adoption of such 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 we’re really committed to compliance with changing worldwide regulations and providing products that meet these needs, for clinicians and patients alike,” said Steve Chatters, executive vice president 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 percent IVDR-ready, but gaining certification for our first set of CytoCell® FISH probes.”
“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,” said Adrian Smith, CEO of OGT.
- This press release was originally published on the Oxford Gene Technology IP Limited (OGT) website