What makes the UK cryogenic equipment market different from European and US markets and what should UK IVF laboratories check when buying?
The UK cryogenic equipment market diverged from the European regulatory framework following the UK’s departure from the EU in 2021. Since January 2022, products placed on the UK market must carry UKCA marking rather than CE marking to demonstrate conformity with UK product safety requirements. CE marking remains valid for products already on the UK market under transitional arrangements, and products supplied to European IVF clinics by UK-based suppliers still require CE marking. For UK IVF laboratories, this means checking both marks when sourcing equipment from suppliers who operate across both markets.
The US market operates under entirely different regulatory frameworks, with FDA oversight for medical devices and different standards for cryogenic vessel construction and testing. US-manufactured equipment without UKCA or CE marking is not suitable for use in HFEA-licensed UK facilities without additional conformity assessment. Cryolab operates exclusively in the UK and international biological cryogenic sector and has supplied UKCA and CE marked equipment to UK IVF clinics, NHS fertility units, and sperm banks for over 40 years. View the full Cryolab product range or contact us for compliance documentation specific to your facility’s requirements.
