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

• 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

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

• include?

• How does this interact with other pre-existing medical device and ESG legislation?

• MDR

  • Batteries

  • REACH

• Current adoption status
• Best practices to ensure readiness to comply

• With Product Liability Directive 85/374/EEC having been adopted, what does this mean for medical device manufacturers?

  • What’s changed and what does it mean for liability looking ahead?

  • How does the directive interact/overlap with other regulations (eg MDR; AI Liability Directive; RAD)?

  • What should manufacturers be doing now to prepare?

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

• With so much buzz around the EU AI Act, what actually is it and why is it so important for industry?

  • Does it only affect manufacturers with AI-enabled devices?

  • Is it already implemented and are there transition times?

  • What implications are there for industry, notified bodies and regulators?

• The regulatory landscape before the introduction of the EU AI Act vs now

  • Which regulations do manufacturers need to be aware of in addition to the EU AI Act?

  • How does the Act interact with EU MDR/IVDR, as well as data protection regulations?

• 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

• Does the AI Act describe data requirements?

  • Which evidence is required for certification under the Act?

  • How does this interact with data requirements from other regulations?

  • Does it differ based on device risk class?

  • How do you know if it is sufficient?

• Collecting suitable data: a working example

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

• A year on from the decision by the Hanseatic Higher Regional Court Hamburg (OLG Hamburg, file reference: 3 U 3/24) regarding telemedicine app – where are we now?

• Competition law and advertising considerations

• How can this situation be avoided?

• Importance of accurate qualification and classification of software and apps

• How does the EU AI Act interact with post-market surveillance and vigilance requirements?

  • Are there additional requirements which need to be considered?

  • How do you monitor post-market for non-static devices and diagnostics?

• Are there any regulations or frameworks around ethics for AI, including in the EU AI Act itself?

• What ethical considerations need to be taken into account?

  • Algorithm transparency and bias

  • Data protection and security

• 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?

• As the debate rumbles on, where are we with global acceptance of in vitro vs in vivo testing?
  • Has the US moved more towards acceptance?
• Industry implications
  • Can industry streamline testing methods to be applicable for both regions?
  • Which areas commonly cause issues with submissions?
    • Practices to overcome

• Summary of the case

• Process of original ruling and subsequent appeal

• Grounds of appeal

• Outcome of case for both RRR and BSI

• Lessons to takeaway for manufacturers and notified bodies

• From a legal perspective, what is the state of play and what are the main elements of new proposals?

• Where will the respective proposals take us and are they a route forward?

  • What would it mean for all stakeholders if the proposals are adopted and do they solve all problems?

• Take this time to put together a mock submission for a device in line with the Act

• Compare and contrast with other workshop participants and gain invaluable feedback from trainers

• Open Q&A