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?

Please contact: Kristen Schott – kristen.schott@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?

The MedTech industry is facing an increasingly complex regulatory environment, with recent updates like the EU MDR, EU IVDR, and the FDA's shift toward ISO 13485 requiring rapid compliance adjustments. Traditional, siloed systems often impede efforts to keep up, as many manufacturers have historically focused on physical products rather than embracing digital innovation. With emerging priorities such as Software as a Medical Device (SaMD), cybersecurity, and sustainability, MedTech companies must adapt quickly or risk falling behind. As regulatory updates become more frequent, digital transformation and real-time traceability are no longer optional—they’re essential for staying competitive. This session will explore practical strategies for navigating these challenges, balancing compliance with innovation, and ensuring sustained success in MedTech. Attendees will gain actionable insights on rethinking strategy and embracing digital solutions to meet evolving regulatory demands, stay competitive, and go to market faster.

Attendees will learn actionable strategies for navigating the complex regulatory landscape and driving digital transformation, ensuring MedTech companies stay compliant, competitive, and innovative in a rapidly evolving market and ultimately go to market faster.

• 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?

• Be a Success-Enabler
• Secure a Place at the Table as a Full Partner
• Better Processes Produce Better Products

• 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