Day Four – 19 June 2025Thursday, 19 June 2025 - CEST Time Zone

• What is classified under Annex 16?

• What is the latest update to the common specifications?

• Are there proposed changes which will affect manufacturers?

• Collecting clinical evidence

  • When and how to collect clinical data under Annex 16

  • How to demonstrate benefit risk

• 1 year on from the MDCG guidance on Orphan devices, what are the current experiences in regulating them?

• Is the guidance clear or is further guidance needed?

• How many have been certified so far?

• How does the future look for Orphan devices?

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

• With the documentation for clinical and performance evidence ever increasing, can companies use AI to help with workload?

• Use of generative-AI in documentation completion or answer generation

• Working example

  • Successful uses of AI

  • Risks to be considered

    • Patient safety

• With EMA’s Darwin Project now in full operation, what are the implications for medical device and in vitro diagnostic manufacturers?

  • Intersection with the European Health Data Space (EHDS)

• Which lessons can be implemented cross-industry

  • Implementation of platforms for data and real world management

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

• MDR vs MDCG definition for WET devices

• Example of WET devices: perspective from notified body

• Level of clinical evidence required for WET devices.

Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any leftover burning questions!