Bad Hersfeld, Germany, 04. November 2025 – p36 GmbH, a leading provider of digital compliance solutions for the life sciences sector, announced the release of UDI Platform Release 3.4, introducing vital enhancements designed to help medical device manufacturers and regulatory teams stay on top of evolving compliance requirements.

Key Highlights from Release 3.4:

• Advanced EUDAMED Update Capabilities:
  For the first time, users can update Basic UDI-DI (BUDI) records after initial publication and submission to EUDAMED. With the new dedicated “Update BUDI Information Basket,” teams can handle regulatory-driven changes swiftly – without impacting device data or duplicate submissions.
• Support for Legacy and Master UDI-DI Devices:
  The platform now offers complete support for EUDAMED content packages for both legacy and master UDI-DI devices. This update enables bulk management of legacy devices and introduces automated ID generation, making it easier to differentiate and process regulated and legacy products in line with the latest EUDAMED specifications.
• Electronic Signatures:
  UDI Platform 3.4 now supports electronic signatures using Microsoft EntraID, allowing organizations to leverage existing company-wide security policies.

“At p36, we understand that regulatory requirements are always changing. With our latest release, we are making it easier for our customer to manage their UDI data, adapt to new rules, and keep the focus on patient safety and innovation,” says Alexander Parr, Division Lead Products at p36.

About p36 GmbH
Since 2019, p36 GmbH has been empowering world-leading life science companies across the globe with tailor-made cloud software. As an independent technology company, we develop SaaS solutions like UDI Platform that simplify regulatory processes, drive digital transformation, and help organizations stay compliant in an ever-evolving industry. Discover more about our commitment to innovation at: http://www.p36.io 

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