EU Medical Device Tracking Requirements
Medical device manufacturers are entering a more demanding phase of EU MDR and EUDAMED readiness. This webinar helps teams understand the latest regulatory expectations, prepare the right data, and avoid gaps that can create compliance risk.
Compliance gaps rarely appear overnight. They build quietly in data, process, and ownership.
Is your EUDAMED strategy ready for what comes next?
With mandatory EUDAMED usage on the horizon, medical device manufacturers need more than surface-level awareness. Regulatory oversights, incomplete data preparation, and unclear ownership can lead to costly disruptions and compliance exposure.
This session is designed for teams that are starting their EUDAMED readiness journey as well as organizations already navigating the complexity of EU MDR, UDI data, and submission preparation.
SCW experts break down what manufacturers need to understand, where the common gaps appear, and how teams can move forward with more confidence and structure.
Practical guidance for medical device compliance teams
The webinar focuses on the operational side of compliance, connecting regulatory requirements with the data, process, and internal alignment needed to execute.
Latest EU MDR developments
Understand the evolving regulatory landscape and the key deadlines medical device manufacturers should keep on their radar.
UDI essentials explained
Clarify the difference between Basic UDI-DI, UDI-DI, and UDI-PI so your team can prepare more accurate device data.
EUDAMED data preparation
Learn how to approach submission readiness, data quality, internal ownership, and cross-functional coordination.
Compliance risk reduction
Identify the hidden gaps that may create regulatory risk before they become urgent business disruptions.
Internal alignment
See how regulatory, quality, master data, IT, and supply chain teams can work from a shared readiness model.
Actionable next steps
Leave with a clearer understanding of what needs to happen next and how to close the gaps with structure.
A focused webinar built for readiness and execution
The session connects regulatory context with hands-on preparation so teams can move from awareness to action.
EU MDR and EUDAMED context
Review the latest requirements, timelines, and why medical device tracking readiness needs attention now.
UDI concepts and data readiness
Break down UDI terminology and connect each requirement to the operational data your organization needs to prepare.
Submission strategy and internal ownership
Explore how teams can structure responsibilities, align stakeholders, and reduce submission-related delays.
Common gaps and practical next steps
Identify the issues that often appear across data, systems, process, and governance before they become compliance blockers.
Led by SCW experts in compliance, project execution, and traceability
Mia Van Allen, MMath, PMP
Managing Partner at SCW. Mia brings deep expertise in serialization, traceability, compliance strategy, and global life sciences transformation programs.
Gözde Çulcu Bozkurt
Project Manager at SCW. Gözde supports complex project execution across regulated life sciences environments, with focus on structure, alignment, and readiness.
Missed the session? Connect with SCW Academy.
This webinar has already taken place. For questions about EU MDR, EUDAMED readiness, UDI strategy, or future SCW Academy sessions, reach out to the team.
