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

• What does the latest revision to ISO 10993-1 really mean for you?

• What are the biggest changes between versions?

• What do manufacturers and testing facilities need to do differently?

• Case study example of adhering to –1 before and after revision

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 biocompatibility 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

• One of the key revisions for –1 centres around genotoxicity, but what does this mean?

• Which groups is this endpoint applicable to now?

• Why has this change materialised?

• What does this increased evaluation mean for wider public health?

• Best practices for applying genotoxicity to those who have not previously

• With –17 having been in place for 1 year, what are industry’s first experiences of adhering to the standard?

• Are there differences in EU and FDA acceptance?

• Can we expect further alignment?

• Which parts are causing the most confusion?

• Possible solutions to ease working under -17

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

• What are these updates?

• Are there any impacts for manufacturers?

• Do biological evaluations and modalities need to be revised?

• Which alternatives are available, and should we consider using them?