Day 1 - Monday 15th June - CEST Time Zone
- Kaitlin Dailey - Senior Conference Producer, Informa Connect
- Key Updates in the EU MDR revision proposal - Overview of proposed changes and latest negotiations
- Implications for Stakeholders - Challenges for manufacturers, Notified Bodies, and healthcare providers, including dual compliance burdens and patient safety improvements.
- Global and Strategic Outlook - Anticipating future bottlenecks, and positioning of the EU within the global MedTech landscape.
- Jeppe Larsen - Director of Medical Devices, Danish Medicines Agency
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD
- Erik Vollebregt - Partner, Axon Lawyers
- Nataliya Deych - Vice President Regulatory Affairs EMEA, Latam, Canada, Edwards Lifesciences
- Bassil Akra - CEO, AKRA TEAM
- The clash between the Digital Omnibus on AI and the MDR/IVDR Proposal - What does this mean for MDAI manufacturers?
- The role of Article 6(1) in defining high-risk AI systems and its impact on medical devices.
- Strategic planning for manufacturers - Preparing for dual compliance or streamlined MDR/IVDR obligations.
- The broader implications of regulatory uncertainty for innovation in MedTech AI.
- Abhineet Johri - Regulatory Affairs Manager & Senior Key Expert-AI, Siemens Healthineers
- Leo Hovestadt - Director Governmental Affairs EU, Elekta
- Felicity Ellis - Head of Legal and Compliance, Scarlet
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD
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.
- Gert Bos - Executive Director & Partner, Qserve Group
- Mahshid Vashaghian - Director of Regulatory Affairs, Edwards Lifesciences
- 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?
- Goran Adburrahman - Senior IVD Product Specialist, TÜV Rheinland
- 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
- Discussing the MDR/IVDR proposal -moving MDAI from Section A to Section B of Annex I
- Extended grace periods under the Digital Omnibus on AI - What do the new timelines mean for compliance planning?
- Arne Sunaert - Inspector Medical Device Software, FAMHP
- Jamie Gallagher - Partner, Mason Hayes & Curran
Exploring the importance of explainable AI in building trust among stakeholders by making AI decisions more transparent and understandable.
Addressing the growing demand for explainability in AI to meet regulatory requirements and ensure ethical decision-making in critical applications.
Discussing tools, techniques, and challenges in integrating explainable AI into real-world systems without compromising performance.
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Vanda Almeida - Responsible AI Clinical Lead, Philips
- Ebube Ogbuagu - Medical Doctor, Royal Derby Hospital, NHS/ Committee Expert AI Airlock, MRHA
Exploring how AI drift impacts the accuracy and reliability of medical devices over time and the need for proactive monitoring strategies.
Evolving Post-Market Surveillance - addressing the role of PMS in detecting and mitigating AI drift through continuous monitoring, real-world data validation, and performance assessments.
- Stephanie Berger - Director Global PMS, Philips
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
- Vaso Basinou - Freelance Consultant, Zena
- Vicky Valla - Freelance, Consultant Regulatory Compliance & Intelligence
- 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.
- Ella Helgeman - Senior Regulatory Director, Radiometer
- Christophe Lahorte - Quality Assessor, FAMHP
- Kerli Kustola - COO, Muun Health
- Esmeralda Megally - CEO & Co-Founder, Xsensio
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.
- Mahua Yasmin - Senior Regulatory Affairs Specialist, Johnson & Johnson
Defining the Gray Zone - examining the challenges of regulating AI-enabled medical devices and their convergence with non-device technologies.
Exploring existing and emerging regulatory approaches to address the blurred lines between AIeMD and non-device solutions.
Highlighting the impact of this convergence on manufacturers, regulators, and healthcare providers, with strategies to navigate compliance and innovation.
- Rebecca Mathias - Research Associate, Medical Device Regulatory Science Group, Else Kröner Fresenius Center for Digital Health
- Leo Hovestadt - Director Governmental Affairs EU, Elekta
- An overview of the key features of new EU product liability framework, with a focus on new legal risks for software developers.
- An understanding of the growing role of product safety compliance in product liability litigation.
- An update on transposition across the EU, and how to prepare for claims alleging harm caused by SaMD and AI.
- Jamie Gallagher - Partner, Mason Hayes & Curran
- Reviewing key insights gained from data collection requirements under the AI Act and their implications for compliance.
Addressing practical obstacles in meeting data collection standards, including transparency, quality, and governance.
Exploring how organizations can adapt their data strategies to align with evolving requirements and ensure long-term compliance.
- Petr Brat'ka - Preclinical Evaluation Manager, Czech Metrology Institute
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
- Vaso Basinou - Freelance Consultant, Zena
- Vicky Valla - Freelance, Consultant Regulatory Compliance & Intelligence
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.
- André Breisinger - Expert Medical Devices Regulation, Swissmedic
For more information, please contact Neha Singh at niha.singh@informa.com
Sharing first-hand experiences of SMEs in preparing for compliance, including resource and knowledge gaps.
Offering actionable steps and best practices for SMEs to meet the EU AI Act deadline effectively.
- Leon Doorn - Chair Medical Device / AI Working Group, NEN (Dutch Standardisation Institute)
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
- Vaso Basinou - Freelance Consultant, Zena
- Vicky Valla - Freelance, Consultant Regulatory Compliance & Intelligence