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Day Two – 17 June 2025 - CEST Time Zone
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
With eyes mainly focusing on the EU MDR, which other wider regulations are there to be aware of which affect the medical device industry?
Sustainability
Data
Digital
How can all stakeholders keep on top of this web of regulatory web?
- Gert Bos - Executive Director & Partner, Qserve Group
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
- Alexander Wenzel - Supervising Associate, Simmons & Simmons LLP
- Svetlana Bykanova - Senior Vice President, Global Quality and Compliance, HOYA Surgical Optics
- Giacomo Cargnello - Head of Quality Assurance & Regulatory Affairs, C&C Solutions, Varex Imaging
- Carmen Ruiz-Villar Fernandez-Bravo - Deputy Director, Medical Devices Department, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
End to end case study of successful certification
Technical file preparation and submission
Notified body review
Common questions, pain points and lessons
- Heinrich Martens - Vice President Regulatory Affairs, Fresenius Kabi Deutschland GmbH
- Beau Rollins - Head of Biocompatibility, ConvaTec
The beginnings of the BE
Intent of a BE
Definitions and foundations
Standard intent vs regulator interpretation
- Tom Patten - IVDR/IVD International Manager, GMED
As IVDs and Pharmaceuticals become ever more intertwined, how are both industries finding collaboration?
Commonalities in regulatory processes, experiences and pain points
How can both sides support each other?
How does increased collaboration impact diagnostic market availability?
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
- Vihanga Pahalawatta - Director Regulatory Affairs Companion Diagnostics, AbbVie
- Lindsay Darling - Director, Companion Diagnostics Portfolio Management & Operations, Regeneron
- Philipp Schatz - Global Regulatory Lead, Bayer
- Vihanga Pahalawatta - Director Regulatory Affairs Companion Diagnostics, AbbVie
- Kristiane Schmidt - Team Manager IVD & Principal Consultant, Qserve Group
With a bigger focus on bringing innovation back to Europe, which innovation pathways are available?
Comparison of pathways from Europe, US, and beyond
Industry case study: getting an innovative device to market
Lessons learned and alterations for other submissions
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Bianca Lutters - Head of Clinical Affairs, Qserve Group
- Vishal Thakker - Head of UK Approved Body, BSI
Your EUDAMED challenge as a manufacturer? Achieve a smooth, efficient, compliant and on-time registration of all your devices in 2025. Based on our multi-year expertise of accompanying manufacturers to become live in EUDAMED, we now unveil to you how you will be able to make it happen in a practical "do's and don't" session
- The surprising roadblocks of the "do it yourself" pathway
- Learnings coming from your peers - based on various company size/product portfolio/data quality and IT maturity
- How to trust both your data and your registration processes to be compliant
- Lionel Tussau - Lead Healthcare, BYRD Health
Utilizing Design inputs
How to properly define intended use and device categorization
Literature search
How to reference competitive devices
Clinical evaluation data integration
Group divisions and BEP creation exercise
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
E&L test requirements and set up
Correct Dose Base Threshold (DBT) for device
Calculation of Analytical Evaluation Threshold (AET)
Method Uncertainty Factor (UF), sensitivity, solvent selection
Applying to intended use and materials
Traditional endpoint tests and critical factors
In-vitro vs In-vivo
Extraction time, temp, and ratios.
Determining gaps from E&L, literature, etc to determine appropriate endpoint test
Group division and BEP completion
- Harmonization of CTA and PSA
- Timing of therapeutic product and CDx approval/co-approval- Oncology and Beyond
- Use of in-house testing exemption to support CDx as needed
- Product Labeling- SmPC and SSP
- Intended purpose/off-label use
- Changes to a CDx Device and Communication with HA
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
- Jörg Engelbergs - Scientific-Regulatory Expert Targeted & Personalized Biomedicines, Paul-Ehrlich-Institut
- Rolf Thermann - Section Manager IVD and Companion Diagnostics Lead, TUV Rhineland
- Camilla Recke - Director Regulatory Affairs - Companion Diagnostics, Agilent
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
With devices having to be registered in EUDAMED by Q3 2026, what is the current state of play?
Early experiences with using EUDAMED
Comparison to SWISSDAMED
Is there also a UK equivalent?
Moving towards end of 2026 grace period – what do manufacturers need to do?
- Janine Reudt-Demont - Partner, Niederer Kraft Frey
- Richard Houlihan - Founder & CEO, EirMed
- Ricky Wong - Regulatory Projects Specialist, MED-EL
Regulatory Affairs is undergoing a transformation as AI and automation replace traditional, manual processes. Through case studies and expert insights, we’ll discuss the balance between human expertise and AI-driven decision-making which ensures efficiency without compromising regulatory integrity. Don't get left behind, embrace the future of Regulatory Affairs today!
We will discuss:
- The shift from manual regulatory tracking to AI-powered automation
- How real-time regulatory intelligence can prevent compliance bottlenecks
- The role of predictive analytics in forecasting regulatory trends
- Case studies on how automation accelerates submissions & approvals
- The balance between human expertise and AI-driven decision-making
- Priya Bhutani - CEO, RegDesk
- Beau Rollins - Head of Biocompatibility, ConvaTec
E&L test reports and applying AET for compound analysis
Acceptance criteria for traditional endpoint tests
Common deviations
What to do if you fail
Addition of all test data and results determination
Gap assessment to data, deviations, historical testing
Developing a final conclusion
Group division and BER completion
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
tests and LDTs
How does regulation differ between the EU and US?
What was changed for all stakeholders?
Areas of particular consideration for manufacturers
Longer term impact of more stringent regulations
- Future outlook on wider patient health and safety
- Alexander Wenzel - Supervising Associate, Simmons & Simmons LLP
- Marta Montilla Gispert - Group IVDR Regulatory Affairs Manager, Unilabs
- Philipp Schatz - Global Regulatory Lead, Bayer
Understanding the EHDS Act
Developments
Primary and secondary use
The regulatory scope of the EHDS Act: MDR, IVDR, data legislation and AI Act
Opportunities for innovation with the EHDS Act
Key risks and mitigation
Future proofing compliance and strategy in light of the EHDS
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any leftover burning questions!
- Gert Bos - Executive Director & Partner, Qserve Group
- Giacomo Cargnello - Head of Quality Assurance & Regulatory Affairs, C&C Solutions, Varex Imaging
Evaluating compounds
NOAEL/LOAEL
Cramer categorization
Unknown determination
MOS calculation per ISO 10993-17
Group division and Tox assessment
Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!
- Tom Patten - IVDR/IVD International Manager, GMED
- Heike Möhlig-Zuttermeister - Global Director in-vitro Diagnostics (IVD), TÜV SÜD
- Rob Laport - Project Manager and Certification Manager Medical Devices, DEKRA Certification B.V.