Day Two – 11 June 2024Tuesday, 11 June 2024

• Current status of diagnostics certified under IVDR
  • Is there set to be a shortage of diagnostics in Europe?
  • How are diagnostic and pharma companies coping with the regulations?
• Upcoming deadlines
  • Class Ds
  • Expected timelines for manufacturers to transition

• 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

• 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

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

• 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?

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

• Current requirements for approving CDx
  • Navigating both IVDR and EMA requirements
• Route to market
  • Required data and documentation
  • Hurdles and solutions along the way
• Future considerations

• Utilizing Design inputs
• How to properly define intended use and device categorization
• Literature search
• How to reference competitive devices
• Clinical evaluation data integration
• Group divisions and BEP creation exercise

• 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

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

• Addition of all test data and results determination
• Gap assessment to data, deviations, historical testing
• Developing a final conclusion
• Group division and BER completion

• 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

• E&L test requirements and set up
  • Correct Dose Base Threshold (DBT) for device
  • Calculation of Analytical Evaluation Threshold (AET)
  • Method Uncertainty Factor (UF), sensitivity, solvent selection
  • Applying to intended use and materials
• Traditional endpoint tests and critical factors
  • In-vitro vs In-vivo
  • Extraction time, temp, and ratios.
  • Determining gaps from E&L, literature, etc to determine appropriate endpoint test
• Group division and BEP completion

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!

• E&L test reports and applying AET for compound analysis
• Acceptance criteria for traditional endpoint tests
• Common deviations
• What to do if you fail

• Defining LDTs
• Where are LDTs covered in both European and US legislation?
  • Overview of proposed rule from the FDA & impact for industry
• Replacement of proposed VALID Act
• Impact of IVDR on clinical trials
  • Do commercial labs qualify?

• IVD lifecycle success requires insights-driven decisions across all stages, such as R&D, regulatory submissions, and post-market surveillance.
• Finding relevant evidence in published literature is crucial but challenging.
• Is there a place for AI in this?

• Evaluating compounds
  • NOAEL/LOAEL
  • Cramer categorization
  • Unknown determination
• MOS calculation per ISO 10993-17
• Group division and Tox assessment

• Current status of regulations for IVDs in Switzerland
• Comparison with rest of Europe
• Case study: end-to-end process of gaining approval
• Common pitfalls and solutions
• Status of FDA approved products for Switzerland

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.

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

• The beginnings of the BE
• Intent of a BE
• Definitions and foundations
• Standard intent vs regulator interpretation

• 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

• How has the introduction of the IVDR influenced innovation?
  • Is there a lack of innovation in Europe?
  • Why?
  • Pathways for industry to expedite market access – international recognition pathways
  • How do innovation pathways in Europe compare to other regions?
  • Future of diagnostic innovation
  • How can all stakeholders encourage innovation in Europe?
  • What is the risk of a fall in innovation?

• With the new UK regulation coming into force from July 2025, what can we expect for placing IVDs on this market?
  • Status of approved bodies
• Timelines for manufacturers
  • Transition periods
  • Timelines from documentation submission to gaining approval