Day Four – 19 June 2025 - CEST Time Zone
What is classified under Annex 16?
What is the latest update to the common specifications?
Are there proposed changes which will affect manufacturers?
Collecting clinical evidence
When and how to collect clinical data under Annex 16
How to demonstrate benefit risk
1 year on from the MDCG guidance on Orphan devices, what are the current experiences in regulating them?
Is the guidance clear or is further guidance needed?
How many have been certified so far?
How does the future look for Orphan devices?
- Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
Identifying the intersection of toxicology and biocompatibility
When does 1 feed into the other?
Best practices for identifying the needs of your device
When does a device need a toxicological risk assessment?
Are there any exceptions?
- Flora Wegener - Lead Scientific Expert Toxicology, Merz Aesthetics
Toxicological risk assessment of chemical constituents of medical devices: application of ISO 10993-17
Hazard identification and implementation of toxicological screening limit
Biological risk estimation within the risk management framework
- Alina Martirosyan - Senior Scientific Manager Toxicology, B Braun
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
What are the newest pieces of legislation which have been released relating to software and AI/ML in Europe?
What have the biggest impact on industry?
What's in the pipeline?
Regulatory priorities for the next year
- Malte Knowles Schmidt - Manager Global Service Portfolio SW, AI and Cybersec. for Medical Devices, TÜV SÜD
Latest regulatory updates from the US
How different are they from European updates?
Are there places of alignment between the 2 regions?
Where can manufacturers streamline documentation or workload?
The future
US priorities for software and AI/ML in the coming year
- Paula Antunes - Global Regulatory Lead, GRA - RA Digital Health & IVD, Novo Nordisk
Manufacturer obligations for medical AI systems
MDR and AI Act requirements regarding explainability and transparency
Operator obligations for medical AI systems
German and European operator law
Implementation of obligations in inactive processes of manufacturers and operators
- Thorsten Prinz - Senior Medical Devices & Software Manager, VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V.
In this opening half an hour, take the time to reflect on your current software and AI journey and discuss with colleagues
Use the post-it notes provided to write down your top comment, question or concern
These will then be addressed by our expert panel during tomorrow’s final session
- About FDA
- Medical devices, IVDs, drugs, combination
- products and CDx: FDA divisions and offices
- FDA Centre for Devices and Radiological
- Health (CDRH)
- Code of Federal Regulations (CFR)
- Standards and other guidance documents
- Harmony & Discord
- A comparison of US and European Medical
- Device Regulatory Affairs
- Regulatory commonalities, overlaps and
- discrepancies
- Future trends
- An introduction to routes to the US Market
- Classification
- Premarket Notification – (510(k)
- Introduction to Traditional, Abbreviated,
- Special, de novo & Exemptions
- Predicates & substantial equivalence
- Premarket approval (PMA)
- Modules, modular and full submissions
- Role of QMS (CFR Part 820)
- Quality Assurance
- Quality Control
- Classification: routes to market
- Comparison with EU/UK
- The 513(g) procedure
- What is Q-sub (still commonly known as a ‘pre-sub) and how does it benefit both the
- manufacturer and FDA
- How to prepare a ‘pre-sub’ document
- The ‘pre-sub’ meeting
- FDA feedback & follow up with the Agency
- Next steps
Implementation update ahead of going into force in 2025
Benefits of update
Limiting of work duplication
Business predictability
Long-term sustainability
With the documentation for clinical and performance evidence ever increasing, can companies use AI to help with workload?
Use of generative-AI in documentation completion or answer generation
Working example
Successful uses of AI
Risks to be considered
Patient safety
- Sepanta Fazaeli - Clinical Systems & Medical Data Systems Lead, Stryker
- Malene Nielsen - Biocompatibility Specialist, QCO, Quality Services, Convatec
Comparison of cybersecurity legislation from both Europe and the US
How do they compare?
Are there places in which one can learn from the other?
How can manufacturers adhere to both sets of regulations, if operating in both regions?
- Tips for best practices
Risk and mitigation techniques for cybersecurity
Dealing with breaches
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Sravani Sreeram Nagasai - Technical Program Manager, Google
- Introduction to ISO 14971 and its Importance in Software as a Medical Device (SaMD)
- Key Principles and Concepts of the Standard for SaMD
- Overview of the Risk Management Process in SaMD
- Application of ISO 14971 in the Development and Maintenance of SaMD
- Common Pitfalls and Best Practices in SaMD Risk Management
- Paul Evans - Head of Quality Assurance and Regulatory Compliance, Digital Health and Care Wales
- The 510(k) process, different types of 510(k) and De Novo submissions
- Predicate Devices
- Contents of a 510(k) submission
- Decision Summaries
- Post-market considerations including modifications to cleared devices (post-market requirements): keeping product on the US market
- The PMA process and different types of PMAs
- Contents of a PMA submission
- Summary of Safety and Effectiveness Data (SSED)
- PMA Annual Reporting
- Modifications to approved devices
With EMA’s Darwin Project now in full operation, what are the implications for medical device and in vitro diagnostic manufacturers?
Intersection with the European Health Data Space (EHDS)
Which lessons can be implemented cross-industry
Implementation of platforms for data and real world management
- Stephen Weber - Assistant Professor, The Johns Hopkins School of Medicine
- Barbara Fink - Associate Director of Clinical Affairs, Philips
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
With the rise in AI, how are companies applying this to ease biocompatibility workload and analysis?
Can generative-AI be used in documentation completion and submission?
Are notified bodies and regulators accepting of AI use?
How is this being regulated?
Can we expect further guidance on using AI for biocompatibility?
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
Locking down risk management strategies
Which regulations and guidance reference risk management for AI?
When to start thinking about and implementing risk management
How do you apply risk management principles for AI-enabled devices?
Case study: risk management in action
- Pat Baird - Senior Regulatory Specialist, Philips
- Arun Mathew - Associate Director, Quality Systems (Risk Management), AbbVie
- Notification [510(k)] vs Approval (PMA) output data requirements
- Preclinical data: design verification
- Clinical data: design validation
- The importance of project management: saving time and cost to market
- Design change: pre-planned and/or response to market feedback
- Imposing Quality throughout the product lifecycle to save time and cost
- Role in Product Development, Design Control and Design Review
- Input to Risk Management
- Importance for manufacturing
- Quality Control
- Audits and Inspections
- Forthcoming regulatory changes
MDR vs MDCG definition for WET devices
Example of WET devices: perspective from notified body
Level of clinical evidence required for WET devices.
- Yu Jin - Global Clinical and Regulatory Affairs Manager, Notified Body 1639, SGS
- Erman Melikyan - Principal Clinician, Intertek
- Milad Masjedi - Global Medical Device Technical Manager, SGS
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!
Biocompatibility beyond check boxes:
How to source and analyze post-market data for Biological Evaluations
Steps to integrate this data and the role of Risk Management
Discussing real-world examples to demonstrate the process
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
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 left over burning questions!
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
What are regulatory sandboxes and what are they used for?
What information do we have on how these will be established in member states?
What do manufacturers need to be aware of?
Can you develop AI without the use of sandboxes?
What opportunities do sandboxes provide and how can they help shape the future of device and diagnostic development?
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Production and process controls
- Information Classification: General
- Inspection of measuring and test equipment
- Process validation