TMRW Vault Obtains CE Marking Under European Medical Device Regulation (MDR)

Wilmington, Del., (ANTARA/PRNewswire)- Reprotech today announced that the TMRW Vault has received CE marking as a Class IIa medical device under Regulation (EU) 2017/745, supporting commercialisation in the European Union and other international markets that recognise the CE mark. This achievement marks a significant milestone for parent company Reprotech and the fertility industry, as the TMRW Vault combines digital chain-of-custody, advanced monitoring, and customisable cryogenic storage to help fertility clinics reduce risk, strengthen specimen traceability, and support growth. The TMRW Vault Freezer is a cryogenic freezer designed to provide storage in liquid nitrogen for oocytes, embryos, and sperm, while facilitating specimen identification and traceability. The TMRW Vault Workstation enables users to move samples into and out of the TMRW Vault Freezer and complete orders through a software interface. As fertility clinics manage increasingly large networks of frozen reproductive material, the need for safer, more scalable, and more traceable storage solutions becomes critical. Historically, clinics have relied on largely manual storage systems, leading to operational inefficiencies and increased risk of human error. TMRW Vault is designed to modernise these processes by combining on-site advanced cryogenic storage infrastructure with TMRW’s ivfOS software platform, creating an integrated solution that enables digital specimen identification, continuous monitoring, real-time inventory management, and a secure digital chain-of-custody that strengthens specimen traceability. TMRW Vault provides fertility clinics with a comprehensive on-site digital specimen management solution that includes: digital specimen management via RFID-enabled CryoBeacons and ivfOS software that digitally verifies specimen identity and location; manual access to advanced technology tanks within the Vault, allowing embryologists to store and retrieve specimens efficiently while maintaining a complete digital footprint; advanced monitoring through TMRW Overwatch, which performs thousands of system checks daily with expert oversight; customisable storage capacity, with a single Vault tank capable of holding as many as ten conventional dewars in approximately one-third of the footprint; seamless integration with the broader TMRW ecosystem and off-site cryogenic storage services; and a straightforward installation process, enabling clinics to deploy the system quickly with minimal disruption. This announcement follows the merger of Reprotech and TMRW Life Sciences in April 2026, combining decades of expertise in cryogenic storage and a national biorepository network in the US with next-generation digital specimen management technology. Together with Reprotech’s acquisition of IMT Matcher in June 2025, the combined organisation now offers fertility clinics one of the most comprehensive ecosystems spanning specimen oversight, digital traceability, on-site and off-site cryogenic storage, consent management, and storage administration and billing.