Day Two – 11 June 2024Tuesday, 11 June 2024 - CEST (Cent Europe Summer, GMT+2)

• A review of the current regulatory ecosystem within Europe
  • Is this the most effective way to get devices onto the market?
  • What hurdles are there with the current system?
  • Which solutions are there for increasing efficiency?
• The future of regulatory
  • What opportunities and risks are there with a more centralised approach?
  • How would this affect regulatory teams?
  • What would the knock-on affect for the wider population be?

EUDAMED is coming with mandatory usage from Q4 2025, do not be fooled it takes a long time to correctly prepare for EUDAMED. This session will highlight some of the pitfalls, experiences to date, and what is needed to submit your data to EUDAMED while keeping budgets as low as possible.

• Experience with MDR as of today
• Challenge(s) accepted! How far are the solutions?
• Perspectives on running a study in the EU

• With the abundance of MDD devices and components still available on the market, is MDR certification always commercially necessary for a legacy device?
• What kind of maintenance and repairs can be performed without triggering a significant change?
• Planning ahead: creating a plan for maintenance and transition

• Regulatory requirements
  • Who needs to have a PRRC
  • Qualifications to be a PRRC
• Responsibilities and Liability of a PRRC
• Knowledge gained from interactions with Notified Bodies and Competent Authorities

• Exploring the most common regulatory submission preparation pathways
• Discussing concerns regarding the current method of submission
• Looking at where regulatory submission and AI interlink and how this can streamline submissions
• Uncovering which parts of the regulatory submissions process can utilize AI most effectively
• Sharing resources and practical tips for implementation

• With the approval timeline expected in Q2 2024, what do we already know about the EHDS?
  • Expected responsibilities of regulators, notified bodies and manufacturers
  • Where does this link into the MDR & IVDR?
  • Link to pharmaceutical industry
• Putting the EHDS into practice: a working example

• Introduction to GS1 as Issuing Agency
• Implementation of GS1 standards for Medical Devices. How to verify that the UDI-DI and B-UDI are valid? Latest information on Master UDI-DI.
• GS1 Belgium & Luxembourg solution to publish B-UDI and UDI-DI to the EUDAMED module Devices

• With MDR now in full swing, how are teams coping with the workload?
  • Impact of MDR on budgets and recruitment
• How can teams ensure employees remain happy and healthy at work?
  • Strategies for coping with increased workloads on the same teams

Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!