Day Three – 18 June 2025Wednesday, 18 June 2025 - CEST Time Zone

• investigations?

• Which new guidances have been released?

• Which areas are working best and which need further reform?

• Future vision

  • What's in the pipeline for H2 2024 and beyond?

  • Are there big updates which industry could prepare for now?

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• In these 15 minutes before the break, take the time to reflect on your current EU MDR journey and discuss with colleagues

• Use the post-it notes provided to write down your top comment, question or concern

• These will then be addressed by our expert panel during tomorrow’s final session

• With the UK moving further along in their regulatory journey, what clinical regulations are there for manufacturers?

• Do they align closely with those of Europe, or other regions?

• Are approved body expectations similar to notified bodies?

• Implications for industry

  • Can data be used cross-regionally?

  • Comparison of documentation requirements between UK and EU

• 2 years since the project was launched, what are the current findings?

  • Which key challenges have been indentified?

  • Are there proposed solutions?

• The future of the project

  • Next priorities and steps

• Following Articles 78 MDR/74 IVDR a coordinated assessment procedure for clinical investigations and performances studies should be provided.

• Solutions without Eudamed

• Purpose of the pilot

• Intended outcomes

• Current status

• Current procedure

• Are there any current learnings from the pilot?

• How will this pilot pave the way for future mandatory implementation?

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• Defining the State of the Art (SotA)

• Why the SotA is important and how it can be leveraged by MedTech business functions

  • What business functions can benefit from an early SotA

  • Role of SotA in the CEP and CDP

  • How conducting the CEP early in the design process assists design and development

• Keeping up with times: continuous evolution of the SotA and the clinical evaluation

• How are notified bodies assessing clinical and performance evidence on manufacturers?

  • Are expectations aligned?

  • Is there further work going into harmonising expectations?

  • Can industry help in harmonisation efforts?