Day Three – 18 June 2025Wednesday, 18 June 2025

• 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

• 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 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?
  
  
• Where does the AI Act sit within our regulations
  • Link to EU MDR / IVDR, GDPR, Cybersecurity, etc...
• What are the ethical considerations in regard to the AI Act
  • Importance of considering ethics for regulatory affairs teams
• Use cases

• 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: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• 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?

• 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

Abstract: An overview of the complex landscape of PFAS usage in medical devices by exploring regulatory requirements and emerging litigation risks.

Key Highlights:

• Classification of PFAS under current EU and UK chemical regimes
• Impact of upcoming PFAS restrictions and related considerations relevant to medical device manufacturing
• Product liability and risk management

• 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

• 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

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• 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.

• Best practice for interactions with Notified Bodies
• Managing timelines, internally and externally
• Claims when you market both MDD and MDR products
• Transparency and how this impacts claims and communications

• 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?

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• 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.

• 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

• 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

• 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?

• 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

• 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?

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

• Once desirable data has been identified, how do you collect this data and use it to support claims?
• Which types of studies are most effective for collecting data in regard to the EU AI Act?

• 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

Please contact: Kristen Schott – kristen.schott@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?

  • How do you ensure the data is GDPR compliance?

• 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?

• 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?

• Which special considerations are there for designing quality systems in line with the AI Act?
• Can manufacturers utilise their pre-existing system, or is a new one needed