TMRW Vault® Receives CE Mark Under the European Medical Device Regulation (MDR)
WILMINGTON, Del., July 6, 2026 /PRNewswire/ -- Reprotech today announced that the TMRW Vault® has received CE marking as a Class IIa medical device under Regulation (EU) 2017/745, supporting commercialization in the European Union and other international markets that recognize the CE mark.
This achievement represents a major milestone for both the parent company, Reprotech, and the fertility industry, as the TMRW Vault combines digital chain-of-custody, advanced monitoring, and scalable cryostorage to help fertility clinics reduce risk, strengthen specimen traceability and support growth.
The TMRW Vault Freezer is a cryogenic freezer intended to provide liquid nitrogen storage for oocytes, embryos, and sperm and to facilitate the identification and traceability of specimens. The TMRW Vault Workstation allows users to transfer samples into and out of the TMRW Vault Freezer and complete orders through the Software Interface.
As fertility clinics manage rapidly growing volumes of frozen reproductive tissues, the need for safer, more scalable, and more traceable storage solutions has become increasingly important. Historically, clinics have relied on largely manual storage systems that create operational inefficiencies and increase the potential for human error.
The TMRW Vault was designed to modernize this process by combining advanced onsite cryostorage infrastructure with TMRW's proprietary ivfOS software platform, creating an integrated solution that enables digital specimen identification, continuous monitoring, real-time inventory management, and secure digital chain-of-custody that strengthens specimen traceability.
The TMRW Vault provides fertility clinics with a comprehensive onsite digital specimen management solution that includes:
- Digital specimen management through RFID-enabled CryoBeacons and ivfOS® software that digitally verifies specimen identity and location.
- Manual access to the Vault's tech-enabled tank, allowing embryologists to efficiently store and retrieve specimens while maintaining full digital traceability.
- Advanced monitoring through TMRW Overwatch®, which performs thousands of daily system checks supported by expert oversight.
- Scalable storage capacity, with a single Vault tank capable of holding as much as ten traditional dewars in approximately one-third of the footprint.
- Seamless integration with the broader TMRW ecosystem and offsite cryostorage services.
- Simple installation, enabling clinics to deploy the system quickly with minimal disruption.
The announcement follows the April 2026 business combination between Reprotech and TMRW Life Sciences, bringing together decades of cryostorage expertise and a U.S. national biorepository network, with next-generation digital specimen management technologies. Together with Reprotech's acquisition of IMT Matcher in June 2025, the combined organization now offers fertility clinics one of the most comprehensive ecosystems spanning specimen witnessing, digital traceability, onsite and offsite cryostorage, consent management and storage administration and billing.
About Reprotech
Reprotech is the leading provider of products and services for the safeguarding, management, and long-term storage of reproductive specimens. Reprotech's combined portfolio includes seven purpose-built biorepositories, advanced cryostorage management technologies and global digital chain-of-custody solutions. Through its TMRW, Matcher, and Cryologix family of companies, Reprotech partners with fertility centers to help reduce risk, improve traceability, streamline workflows, and safeguard specimens throughout their journey. Built on decades of experience and driven by continuous innovation, Reprotech's rigorous compliance standards and operational excellence set the benchmark for protecting specimens from clinic to cryostorage and back, ensuring customers have secure options for preserving what matters most, today and for the future.
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