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?
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
- Gert Bos - Executive Director & Partner, Qserve Group
- Annabelle Bruyndonckx - Partner, 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
Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
Description: Serious incidents related to medical devices must be reported to Swissmedic in Switzerland. The Medical Devices Vigilance (MDV) department is responsible for processing all incoming cases on time. TRICIA can carry out a risk assessment for reports from medical device manufacturers, which supports the MDV department in Swissmedic in assessing the risks of event reports. Internal figures show that the number of reported cases increases every year. With the introduction of the IvDV and the development of the GPx, a further increase in reported cases is also expected over the next few years. Automating the assessment would mean considerably less work for triage. Reports with little relevance can be processed independently, so that they can be better managed by employees therefore increasing organizational effectiveness. In addition, a more homogeneous assessment of cases is possible through the usage of TRICIA. TRICIA is a wonderful case within Swissmedic of what is possible when AI is integrated and thoroughly tested in a meaningful process within the organization.
- Beau Rollins - Head of Biocompatibility, ConvaTec
The beginnings of the BE
Intent of a BE
Definitions and foundations
Standard intent vs regulator interpretation
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina
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, Bayard
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
Current status of regulating companion diagnostics under both IVDR and EMA
Are there differences in regulating oncology CDx vs others?
Does every assay need to be CE marked?
Experiences with regulating these types of diagnostic
Comparison of competent authority, notified body, and industry experiences
Common challenges and methods to overcome
- 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?
- Richard Houlihan - Founder & CEO, EirMed
- Janine Reudt-Demont - Partner, Niederer Kraft Frey
- Ricky Wong - Regulatory Projects Specialist, MED-EL
- 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
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina
Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
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
- Annabelle Bruyndonckx - Partner, Simmons & Simmons LLP
- Marta Montilla Gispert - Group IVDR Regulatory Affairs Manager, Unilabs
- Kristina McGuire - Executive Director and Head, Precision Medicine Laboratory Operations and Companion Diagnostics, Regeneron
- 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
With the US shifting to align with QMS 13485, what does this mean for manufacturers operating in the US market?
Is there much difference between the existing QMSR and 13485?
How much does a manufacturer need to change?
What impact will there be, if any, on the European market?
What does this harmonisation mean for the future?
Can further harmonisation between the EU and US be expected on other regulations?
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina
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
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina
- Heike Möhlig-Zuttermeister - Global Director in-vitro Diagnostics (IVD), TÜV SÜD
- Rob Laport - Project Manager and Certification Manager Medical Devices, DEKRA Certification B.V.