Agenda - Day 1 - Monday 15th June

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EU Regulatory Affairs - Day 1

11:05 - 11:10

Chairperson Remarks

11:10 - 11:55

Balancing Risk and Patient Safety: Redefining Risk Acceptance in the Wake of EU MDR/IVDR Revisions

Examining how EU MDR/IVDR revisions are reshaping the definition of risk acceptance in medical device and IVD development.
Adapting to change - providing actionable insights for manufacturers to align risk management practices with the new regulatory expectations.

Gwennaelle Even - Deputy Director of Division for Medical Devices, Cosmetics and in vitro Diagnosis Devices, ANSM
Gert Bos - Executive Director & Partner, Qserve Group

11:55 - 12:40

Streamlining EU Medical Device Conformity Assessment: Navigating the proposed Annex VII Implementing Act

Goran Adburrahman - Senior IVD Product Specialist, TÜV Rheinland
Giacomo Cargnello - Head of Quality Assurance & Regulatory Affairs, C&C Solutions, Varex Imaging
Marta Carnielli - Head of Certification IVD, TÜV SÜD
James Shearn - Director, Regulatory Intelligence & Policy, Steris

12:40 - 13:10

Strategizing Data Protection in MedTech: Compliance, Communication, and Prioritization

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

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EU Regulatory Affairs - Day 1

14:35 - 15:20

Roadmap for Breakthrough Medical Devices: Strategies, Updates, and Key Takeaways

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.

15:20 - 15:50

Spotlight Presentation Opportunity

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

15:50 - 16:20

Bridge between different regulatory landscapes (EU; FDA; Asia)

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.

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EU Regulatory Affairs - Day 1

16:50 - 17:20

Spotlight Presentation Opportunity

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

17:20 - 17:50

swissdamed and Swiss Medical Devices Ordinance: integration in the European context

Exploring the objectives and key differences between the Swiss and the EU regulatory system.
Addressing the key challenges and timelines
Practical strategy for manufacturers to navigate swissdamed and ensure seamless market access in Switzerland.

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