The UDI module has now passed its full audit. After several years of delays, the European Commission has finally concluded the assessment of the first four EUDAMED modules. With their publication in the Official Journal of the European Union (OJEU), the countdown has officially begun:
️In just 6 months, the UDI module will become mandatory.
For medical device manufacturers, this means action is required now. The UDI/product registration module—one of the most demanding parts of EUDAMED—will soon be compulsory.
Modules audited and approved
- Actor registration
- UDI / product registration
- Notified bodies & certificates
- Market surveillance
Why this matters
Failure to comply once the transition period ends may lead to significant consequences, including sales restrictions, product recalls, or financial penalties. With additional modules (like Vigilance) approaching, achieving UDI compliance is the cornerstone for all future EUDAMED obligations.
How Asphalion supports you
With AsphaEudaMate, our dedicated EUDAMED compliance Machine-to-Machine (M2M) software, you can efficiently manage and streamline all UDI-related processes in bulk.
Start using AsphaEudaMate, the only EUDAMED Manager without any subscription requirements.
️You can also request a no-obligation demo to explore the platform’s full capabilities and understand how our economic cost advantages compare to competitors.
Let us help you achieve seamless UDI–EUDAMED compliance: [email protected]
