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?

• Learn about the new version of the good clinical practice standard ISO 14155 by reflecting on the published final draft
• Reflect on the key updates brought forward by the new version in the area of risk management
• Understand the update timelines and implications to ongoing and future clinical investigations.

Please contact: Kristen Schott – kristen.schott@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

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

  • Which key challenges have been identified?

  • Are there proposed solutions?

• The future of the project

  • Next priorities and steps

• Combined studies - the Swiss approach

  • Combined studies are challenging authorities around the globe. Swissmedic (The Swiss Agency for Therapeutic Products) is approving both, clinical trials with Medical Devices and clinical trials with Medicinal Products, but these procedures differ between the approving divisions within Swissmedic. Accordingly, Swissmedic had to harmonize procedures in order to enable a coordinated approval for combined studies in Switzerland. This Swiss solution is briefly presented.

• 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: Kristen Schott – kristen.schott@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?