• What to do if the device has no direct effect on the patient?
• How to identify gaps in evidence?
• What can be discussed with the Notified Body and what does leveraging clinical evidence mean?
• What guidance and standards for clinical evidence is coming?
• How to structure clinical evidence?
• What to do if there is not sufficient clinical evidence?

• Identifying audit essentials
  • Required data and documentation for audits
• Common questions
• Best practices for audit planning

• Classification of substance-based devices
  • What falls under this category under the MDR?
  • Identifying mechanism of action
• Working with Notified Bodies in certification process
  • Sufficient clinical data
  • Documenting intended purpose
• Route to market

• Current status
  • How many health systems are involved?
  • Integration status
  • Interaction with EU MDR, UKCA and Swiss
• Paving the way
  • Next steps in integration
  • Future implications on healthcare industry and patient care

• Background and definitions
• Process overview
• Case stories and examples
• Considerations to make when identifying the right outcome parameters

• Obligations of medical device manufacturers
  • Benefit Risk Assessment (BRA)
  • Examples & challenges
• Implementation and Practical Issues
  • Raw material specification
  • Supplier documentation

• Latest modules released
• Complying with EUDAMED
  • Deadlines
  • Bottleneck
  • Practical solutions
• Roadmap for EUDAMED

The introduction of new UDI requirements in the EU MDR/IVDR regulations has fueled an increased focus by regulatory affairs teams. However, Europe is not the only region that is adding UDI requirements for medical technology products. Countries around the world from Saudi Arabia to Singapore have implemented some aspects of UDI, and many more will come online in the coming years. While UDI and other product labeling information have typically been maintained separately from other regulatory information, the growing complexity of supporting multiple markets is introducing compliance challenges. Companies can no longer treat it simply as an operational or supply chain process.

EUDAMED delays have given companies a slight reprieve, but the time to get a handle on UDI data is rapidly running out. This session will explore UDI requirements across several major markets, including the types of devices that are covered and the expected implementation timelines. We’ll discuss best practices for managing UDI information – including new Basic UDI-DI fields – by centralizing it alongside product registrations, certificates, manufacturing site licenses, and other critical regulatory information.

Attendees will learn:

• How products will be impacted by MDR/IVDR as well as other global UDI requirements
• Data requirements and issuing entities for different regions
• How to curate “universal” UDI data for reuse across country-specific submissions

• MDR requirements on UDI system
• Timeline to keep in mind
• Actors involved and relevant requirements: a visual summary
• Where information on UDI is available

• Status update on global UDI implementation
• EUDAMED and GUDID
• Adopting a global labelling system to streamline approaches
• Key challenges with implementation
• How is industry handling data?
• Addressing bottlenecks for manufacturers

• The current MDR deadlines
  • What are the new deadlines for each device type?
  • Does everyone qualify for the extensions?
• Impact on the medical device hierarchy
  • Do industry really have more time for MDR submissions with these extensions?
  • How does this affect Regulatory Authority and Notified Body capacity?
  • Best practices from all stakeholders to meet the new deadlines
  • Perceived effect on medical device market in light of the new deadlines
• Will enough devices be certified to cope with market demand by 2027/2028?