Day 1 - Monday 15th JuneMonday, 15 June 2026 - CEST Time Zone

• Examining how EU MDR revisions are reshaping the definition of risk acceptance in medical device development.

• Adapting to change - providing actionable insights for manufacturers to align risk management practices with the new regulatory expectations.

• How evolving regulations are impacting the design, approval, and lifecycle management of single-use and reusable devices.
• Addressing the relationship between hospital autonomy and manufacturer-driven device usage recommendations.
• Legal and ethical implications of device failures, who bears the responsibility—manufacturers, hospitals, or third-party reprocessors?
  
  

• Risk mitigation in data infrastructure - addressing compliance risks within data management systems
• Streamlining internal communication - identifying friction points to enhance collaboration across teams
• Effective data protection prioritization for manufacturers - exploring strategies to prioritize data protection effectively

• Highlighting the latest regulatory changes and their implications for accelerating innovation in the MedTech sector.
• Addressing common hurdles and lessons learned to guide stakeholders in bringing breakthrough devices to market successfully.
• Exploring how SMEs can best leverage the breakthrough medical device pathway to compete in the MedTech industry.

For more information, please contact Neha Singh at niha.singh@informa.com

• Strategies for aligning product development and approval processes to meet diverse regulatory requirements across regions.

• Exploring opportunities for harmonization and collaboration to streamline global market access and reduce regulatory complexity.

For more information, please contact Neha Singh at niha.singh@informa.com

• Exploring the key components and objectives of the Medical Devices Ordinance (MedDO) and Swissdamed integration.
• Addressing the challenges and opportunities in aligning with Swiss-specific requirements while maintaining compliance with broader EU frameworks.
• Providing strategies for manufacturers to navigate the integration process and ensure seamless market access in Switzerland.