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

• 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?

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

Please contact: Kristen Schott – kristen.schott@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

• 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

• 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?