Asphalion launches AsphaEudaMate, the new M2M tool for large-scale UDI uploads to EUDAMED

Asphalion launches AsphaEudaMate, the new M2M tool for large-scale UDI uploads to EUDAMED

Barcelona, December 4, 2025 — Asphalion, an international consultancy specializing in medical device and pharmaceutical regulation, has officially announced the launch of AsphaEudaMate, a digital solution specifically designed to support medical device manufacturers in the bulk upload of UDI data into EUDAMED, the European database for medical devices.

The release comes at a pivotal moment for the industry: the UDI module of EUDAMED has successfully passed its full audit, and the European Commission has published in the Official Journal of the European Union the completion of the review of the system’s first four modules. This means that manufacturers now have only six months left before the UDI module becomes fully mandatory.

A critical milestone for the MedTech sector

The UDI/Device Registration module—one of the most complex components of EUDAMED—is essential for ensuring device traceability, transparency, and regulatory compliance across the EU market. Failure to meet the requirements after the transitional period may lead to serious consequences, including financial penalties, marketing restrictions, or even product withdrawals.

With additional modules such as Vigilance expected to follow soon, achieving UDI compliance becomes the regulatory foundation for all upcoming EUDAMED obligations.

AsphaEudaMate: full automation and up to 70%-time reduction

To support manufacturers in meeting these demanding requirements, Asphalion has developed AsphaEudaMate, a Machine-to-Machine (M2M) platform fully integrated with EUDAMED’s DTX (Data Exchange) system.

The tool enables automatic, large-scale data transfer between an external backend system and EUDAMED’s backend services, allowing manufacturers to upload all their UDI records in a single step—without manually entering information into the EUDAMED interface.

Using a simple, pre-structured spreadsheet, Asphalion’s team can generate and upload all required XML files, dramatically accelerating the process. The tool is especially advantageous for manufacturers with more than 50 SKUs or product references, achieving up to a 70% reduction in workload.

Key features of AsphaEudaMate

• M2M bulk upload functionality fully integrated with EUDAMED’s DTX system
• End-to-end support: from spreadsheet preparation to XML generation and upload
• No need for costly external software
• Fully aligned with EUDAMED’s official data structure
• Fixed-price packages tailored to UDI volume
• Optional data-entry and validation services at discounted rates
• No recurring fees — updates only when necessary
• Developed and operated by MedTech regulatory experts

AsphaEudaMate positions itself as an essential solution for manufacturers needing to scale and secure their UDI compliance ahead of EUDAMED’s upcoming mandatory phase.