Ready for mandatory EUDAMED registration? How LORENZ drugTrack simplifies Medical Device compliance
Posted on March 3, 2026
Regulatory requirements for medical devices in Europe are increasing – and EUDAMED is a key part of this change. For companies placing medical devices and systems or procedure packs on the European market, registrations in the EUDAMED database will be mandatory from May 28, 2026.
EUDAMED requires validated, structured data and defined submission formats – making manual processes and spreadsheets inefficient and risky.
With drugTrack, you are prepared! drugTrack will introduce support for medical device registration in EUDAMED from Q2 2026.
Preparing early is essential to ensure compliance, data quality, and efficient regulatory processes.
What is EUDAMED?
EUDAMED is the European database established under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It provides a centralized view of medical devices available in the EU and aims to improve transparency and coordination between Member States.
EUDAMED consists of six modules. Of these, the first four — actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, and clinical investigations and performance studies — will become mandatory in May.
How drugTrack supports EUDAMED preparation
With the upcoming major release 26.1 on April 30, drugTrack will support the EUDAMED data model and will allow you to manage your medical device data in a compliant way. Medical device registration in EUDAMED will be included from Q2 2026, simplifying and automating the registration processes. This enables manufacturers to prepare early for upcoming regulatory requirements and approach EUDAMED registrations with greater confidence.
Key capabilities include:
- UDI Data Management submit UDIs, Basic UDI-DIs, and container packages
- Automated XML Generation aligned with EUDAMED specifications
- Secure Submission Gateway for encrypted transmission to EUDAMED
- Validation Engine for real-time compliance checks before submission
- Multi-Device & Multi-User Support with role-based access control
With drugTrack your company can:
- Reduce manual data entry
- Ensure compliance with the UDI and device registration module
- Save time and reduce regulatory risk
- Improve data quality and integrity
- Maintain audit-ready logs for transparency
EUDAMED readiness starts with the right tools
EUDAMED readiness requires more than technical access – it requires clean data, structured processes, and reliable validation. drugTrack helps manufacturers prepare early and approach EUDAMED with confidence.
Contact us for more information about drugTrack and EUDAMED preparation by clicking on the button below.
This entry was posted in LORENZ Solutions and Services.