We are pleased to announce that SpermSearch.AI is now UKCA marked and registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a Class I medical device. It is now available for supply in Great Britain, so IVF and andrology laboratories in England, Scotland and Wales can bring it into their sperm search workflows.
What UKCA marking means
UKCA marking and MHRA registration mean SpermSearch.AI can be legally supplied in Great Britain as a medical device. NeoGenix supports it through its quality management system and an ongoing post-market surveillance program.
Regulatory status
SpermSearch.AI is UKCA marked, registered with the MHRA as a Class I medical device and available for supply in Great Britain. It is included in the Australian Register of Therapeutic Goods (ARTG 528777) and is available for supply in Australia. It is intended to assist trained embryologists and andrologists in the real-time visual search for sperm, and does not replace clinical judgement. Our UK Responsible Person is MG Regulatory.
Thank you
A big thank you to MG Regulatory, our UK Responsible Person, for guiding us through the process. They have been an amazing team to work with. Thank you also to everyone else who helped get this over the line. We can’t wait to start working with clinics in Great Britain.
If you run an IVF or andrology laboratory and would like to see SpermSearch.AI in action, we’d love to show you. Email sales@neogenixbiosciences.com or request a demo. You can read more about how it works on the SpermSearch.AI page.
