Day One – 16 June 2025Monday, 16 June 2025 - CEST Time Zone

• With the first set of deadlines now only months away, how are all stakeholders coping?

  • Are notified bodies keeping up with submissions?

  • Are manufacturers submitting in time?

• Current European outlook

  • Does Europe look to be in a better shape, having extended the transition deadlines?

  • Which areas are still causing concern?

  • Proposals for ensuring European healthcare continues moving forward

• What is the latest news on UK regulations for medical devices?

  • What do we know in terms of alignment with Europe, Switzerland and beyond?

  • Will manufacturers have transition times and what are the proposed dates?

  • What can manufacturers do now to prepare?

• 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

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

• Latest news on the regulatory pathway to Switzerland

• The role of the CH-REP

• Status of acceptance of FDA-products

• Status of the MRA EU-CH

• Priorities for 2025

• Since the Battery Regulation was released in July 2023, how have manufacturers been coping with adhering to the new regulation?

  • How does it tie in with the overall MDR?

  • How are notified bodies assessing batteries in devices?

  • What is the wider impact on public health?

• With Article 10a now having been in place for a few months, what initial learnings are there?

  • Is guidance clear on responsibilities?

  • Are there any common pain points arising from the process?

  • Are there any further plans to further reform the process for shortages?

• New regulatory frame in Europe - MDR challenges for all the stakeholders

• Compliance strategies to fulfil the requirements – ROBUST RECEPTION

• Lessons learned from our experience

• Reflecting on the MDR journey so far, how efficient is the current process?

  • Which processes cause the most delays in product certification?

• Future reform: how can efficiency be improved?

  • Use of digital tools and AI

  • Multistakeholder collaboration