With the 26.1.0.0 release on April 30, 2026, the medical device module has been redesigned and now supports the EUDAMED data model. You can easily manage your medical device data in full compliance and the registration process directly from our RIM solution. This will allow you to approach EUDAMED registrations with greater confidence.
Find out what LORENZ drugTrack can do for you
Leverage LORENZ RIM Workflows & Capabilities
All-in-one efficiency: automate workflows, reduce manual effort, and stay in control with powerful dashboards, approvals, and audit trails.
Ensure EUDAMED Compliance with Confidence
Built for compliance: manage UDI data and registrations seamlessly with a system aligned to every EUDAMED requirement.
Identify Relevant Data with Ease
No more guesswork: instantly spot required fields with smart tagging and guided insights for accurate, complete data.
Dedicated EUDAMED Views for Full Visibility
See it before you send it: preview your submission in one click and eliminate uncertainty.
Built-In Validation for Reliable Compliance
Get it right the first time: real-time validation catches errors early and ensures submission-ready data.
Automated XML & Secure Submission Gateway
From data to submission in one step-auto-generated EUDAMED XML files are securely transmitted via AS4, with no need for your own access point. Fast, encrypted, effortless.
How drugTrack can help you with EUDAMED registration
Utilize LORENZ RIM workflows & capabilities
Benefit from all the well-known capabilities such as dashboards, reports, 4-eyes-approval, audit trails, volume create & edit functionalities and even more.
Streamline the process of managing product information by also reducing the amount of data entry required and therefore minimize the risk of errors.
Use your medical device product information from your RIMS to submit your registration. Transparency is essential for control and traceability and our solution offers a full overview of processes, versioning, as well as audit trails, giving you greater control over your work and content.
Ensure EUDAMED compliance with confidence
drugTrack's database is fully EDUAMED-compliant and has all necessary fields for registering your medical devices in EUDAMED.
Easily manage product information and your UDIs, Basic UDI-DIs, plus packaging data.
Full compliance with the UDI and device registration module for manufacturers is ensured.
Identify relevant data
Manage your data for the EUDAMED standard: Let drugTrack show you which fields are relevant for EUDAMED (or any other standard) with colored tagging and mouseovers.
This supplementary information outlines the exact EUDAMED requirement for these fields.
You can even create additional specific tags for data that is owned by various dedicated departments.
Dedicated EUDAMED Views of your medical device data
See what you will be sending to EUDAMED at once glance. Unsure of what you will be sending? Simply click one button to check.
Built-In Validation
Real-time data validation against the EUDAMED specification ensures data accuracy and compliance before submission.
By validating your data within drugTrack, you can make sure that your data is technically compliant and any error can then directly be corrected before submitting.
Automated XML Generation & Secure Submission Gateway without the need to apply for your own access point
drugTrack auto-generates XML files that meet EUDAMED standards to be submitted via AS4-gateway Encrypted, direct transmission to the EUDAMED database.
Our RIM Solution offers you the possibility to use our multi-tenant access point making it quick, easy and effortless to register your medical device data without the need to apply for your own access point.
