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MedTech Summit
10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)
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Day Three – 12 June 2024

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Clinical Evaluations and Investigations & Performance Evaluations
Biocompatibility for Medical Devices
In Vitro Diagnostic Regulations
Regulatory Affairs in Global Markets: US Region
14:10 - 14:15
Chairperson’s Afternoon Remarks: Biocompatibility for Medical Devices
Chairperson’s Afternoon Remarks: Biocompatibility for Medical Devices
09:15 - 09:55
Overview of US FDA Regulation of Medical Devices
Overview of US FDA Regulation of Medical Devices
  • 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 discprepancies
  • 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
15:15 - 15:45
Clinical Trials & Pharma: Assessing the Impact of the IVDR
Clinical Trials & Pharma: Assessing the Impact of the IVDR
  • What is the impact of IVDR on the ability to enroll patients into trials?
    • How is IVDR impacting trials that have patient selection and further what is the impact to inclusion/exclusion and assays/data used for medical management?
    • How is country by country variability impacting trials and how divergent are the various opinions?
  • What is the expected impact of the US LDT regulations and what is different/the same to IVDR?
  • What infrastructure is needed to support these changes for drug developers, sites and laboratories?
  • Have laboratories managed to meet the requirements of IVDR and what are the current gaps?
  • What infrastructure does the industry need to build for a better future state?
Kristina McGuire - Executive Director and Head, Precision Medicine Laboratory Operations and Companion Diagnostics, Regeneron
14:10 - 14:15
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Regulations
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Regulations
08:40 - 09:25
Class D The Latest News: Conformity Assessments and Common Specifications
Class D The Latest News: Conformity Assessments and Common Specifications
  • Conformity assessments for Class D
    • Current requirements from Notified Bodies
    • Challenges for manufacturers
  • A focus on current common specifications
    • What changed within the new version?
    • How much effect does this change have on industry?
    • How are notified bodies ensuring compliance to these specifications?
Tommy McDonagh - Associate Director Regulatory Affairs (IVDR), Abbott Core Diagnostics
11:55 - 12:40
The Impact of IVDR for Health Institutions
The Impact of IVDR for Health Institutions

What is the practical impact of IVDR for health institutions, both when new CE-IVD kits come onto the market and when CE-IVD kits are (temporarily) taken off the market? Where can health institutions collaborate with industry to increase patient safety?

Elizabeth Dequeker - Head of the Biomedical Quality Assurance Research Unit, University of Leuven
16:15 - 16:45
Adhering to PMS Vigilance Requirements: EU vs UK
Adhering to PMS Vigilance Requirements: EU vs UK
  • Current requirements for adverse events, FSCAs and trend reporting
  • Similarities and differences across regions
  • UK Case study: filing an adverse event on new MORE Web Portal
    • Differences between UK & Northern Ireland
Laurent Oliviero - Complaint Handling Specialist 4, QuidelOrtho
17:00 - 17:45
Regulatory Panel Q&A
Regulatory Panel Q&A
  • Meeting regulatory expectations in biocompatibility testing for medical devices

  • Biocompatibility challenges during MDR certification of legacy devices.

  • Addressing the “gap’ between regulatory expectations and industry practices

Christina Reufsteck - Biocompatibility Expert, TÜV SÜD
Jeannette van Loon - CEO, Medical Device Project B.V
14:15 - 15:15
Harvesting and Using Real-World Evidence (RWE) for Devices & Diagnostics
Harvesting and Using Real-World Evidence (RWE) for Devices & Diagnostics
  • Under which regulations can RWE be used?
    • Is RWE enough on it’s own or does a clinical trial always need to be carried out?
    • Can it be used for both devices and diagnostics?
  • Case studies: suitable RWE for differing risk classes
    • Examples of collection, analysis and use in technical documentation
Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
11:10 - 11:55
Shared Experiences: Leveraging Data from Previous Submissions
Shared Experiences: Leveraging Data from Previous Submissions
  • With reference to MDCG 2022-14, is leveraging data a falsehood?
    • When can data be leveraged or when is new data collection necessary?
    • Which data could be leveraged?
    • Could it be leveraged for devices of all classes?
  • Case study: unsuccessful use of previous data and lessons learnt
  • Tips for future leveraging attempts
Heike Moehlig-Zuttermeister - Director Expertise Management & Segment Manager IVD, TÜV SÜD
10:10 - 10:40
Best Practices in the Use of PMCF Surveys
Best Practices in the Use of PMCF Surveys
Marcus Torr - PMCF / MDR Lead, Purdie Pascoe
14:15 - 15:00
Moving Forward: ISO 10993-17:2023
Moving Forward: ISO 10993-17:2023

With the recent updates and newly revised ISO 10993-1, join us in discussion as we navigate the anticipated effects of these regulatory changes.

Alina Martirosyan - Scientific Manager Toxicology, B Braun
09:40 - 10:10
Clinical Investigations and Evaluation: How to Ease Transition to MDR
Clinical Investigations and Evaluation: How to Ease Transition to MDR
  • Eudamed Clinical Module: overview and status / transparency
  • Clinical investigations and PMCF applications: key insights and harmonized approach?
  • Diversity of clinical data collection?
  • Which improvements from MDCG 2022-14 would be of values to the MDR transition?
Carine Cochereau - , Integra LifeSciences
14:45 - 15:15
Cross-Industry Learning: The Impact of IVDR on the Pharmaceutical Industry
Cross-Industry Learning: The Impact of IVDR on the Pharmaceutical Industry
  • Potential Shortages of Commercially Available tests and an expected reduction in labs able to use IH-IVDs (LDTs for routine testing purposes with Precision Medicines
  • Potential delays in clinical trials of Precision Medicines using IVDs with a medical purpose.
Patrick Fivey - Director of Precision Medicine Policy, AstraZeneca
11:10 - 11:55
1. Material-Mediated Pyrogens in Medical Devices: Myth or Reality? European MedTech Summit.
1. Material-Mediated Pyrogens in Medical Devices: Myth or Reality? European MedTech Summit.
Kelly Coleman - Toxicologist, Medtronic
14:20 - 15:10
Product Development US Style
Product Development US Style
  • 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
09:00 - 09:10
Chairperson’s Opening Remarks: Biocompatibility for Medical Devices
Chairperson’s Opening Remarks: Biocompatibility for Medical Devices
Beau Rollins - Director, Quality Services, ConvaTec
15:10 - 15:45
Quality System Regulation: 21 CFR 820
Quality System Regulation: 21 CFR 820
  • 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
11:55 - 12:40
Supporting Indirect Clinical Benefits in Clinical Evaluations
Supporting Indirect Clinical Benefits in Clinical Evaluations
  • Overview of Direct vs. Indirect Clinical Benefits and the challenges
  • Defining Safety and Performance Outcomes and Acceptance Criteria for Indirect Clinical Benefits
  • Leveraging Safety and Performance Standards vs. Clinical Literature
Adam Kleinman - Senior Medical Writer, Philips
Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
Golddy Kaur - President, MedTech Regulatory Strategist
17:00 - 17:45
Ensuring Diverse Representation in Clinical Evaluations & Investigations and Performance Evaluations
Ensuring Diverse Representation in Clinical Evaluations & Investigations and Performance Evaluations
  • How diverse is clinical and performance data which is currently being collected?
    • Is diversity covered in regulation?
    • How much obligation is there for collecting diverse data?
    • Availability and usability of diverse data
  • Importance of enhancing diversity moving forward
Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
Maya Balamane - Senior Clinical Scientist, Intuitive
14:15 - 14:45
Spotlight Session: Navigating In Vitro Diagnostic Regulations
Spotlight Session: Navigating In Vitro Diagnostic Regulations

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

14:10 - 14:15
Chairperson’s Afternoon Remarks: Clinical Evaluations and Investigations & Performance Evaluations
Chairperson’s Afternoon Remarks: Clinical Evaluations and Investigations & Performance Evaluations
Bassil Akra - CEO, AKRA TEAM GmbH
11:10 - 11:55
Data Collection and Sufficiency: What to Collect and What’s Enough?
Data Collection and Sufficiency: What to Collect and What’s Enough?
  • Determining data sufficiency under the MDR & IVDR
    • Are clinical or performance studies always necessary?
    • When can you leverage previous data?
  • Best practices for ensuring sufficient data
Wojciech Bobela - Senior Regulatory Affairs Specialist, Novocure
Ella Helgeman - Regulatory and Quality Director, Rehaler
Nunung Nur Rahmah, M.D., Ph.D - Head of Internal Clinical Team, DEKRA
11:55 - 12:40
Importance of ISO 10993-12: Test Article Preparation and Extraction Considerations.
Importance of ISO 10993-12: Test Article Preparation and Extraction Considerations.
  • Proper study design and thorough planning that considers device-specific intricacies in sample preparation is crucial for a successful biological evaluation. Improper sample preparation or extraction conditions can lead to additional evaluation time, testing costs, and animal use.

    In this session, we will discuss some of the main contributing factors associated with:

    • Improper test article preparation.

    • Improper extraction conditions.

Catherine Christensen - Principal Toxicologist, Medtronic
16:15 - 17:00
An Alternative Perspective: Research-Initiated Studies
An Alternative Perspective: Research-Initiated Studies
  • Determining what is and when to use research-initiated studies
    • Influence of medical staff in initiating studies
    • Benefits of such studies
  • Best practices in fostering working relationships with hospitals
  • Future impact
    • How can utilising research-initiated studies benefit industry and the wider population?
Sara Edvardsen - Research Scientist - Centre for Medical Devices, Technology and Innovation, St. Olavs hospital, Trondheim University Hospital
Shelley Jambresic - Senior Clinical Evaluation Manager, Geistlich Pharma AG
10:15 - 10:40
The Q-submission procedure
The Q-submission 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
08:30 - 08:40
Chairperson’s Opening Remarks: In Vitro Diagnostic Regulations
Chairperson’s Opening Remarks: In Vitro Diagnostic Regulations
Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
09:10 - 09:55
ISO 10993-1: Expected Changes to the Biological Effects of Medical Devices
ISO 10993-1: Expected Changes to the Biological Effects of Medical Devices

The revised draft of the new Part 1 has brought about multiple changes so join us as we discuss its effects on the biological evaluation process.

Jeannette van Loon - CEO, Medical Device Project B.V
14:10 - 14:20
Chairperson’s Afternoon Remarks: Regulatory Affairs in Global Markets: US Region
Chairperson’s Afternoon Remarks: Regulatory Affairs in Global Markets: US Region
Shikha Malik - Senior Regulatory Affairs Specialist, Medtronic
Chris Bray - Head Global Regulatory Affairs, Precision Medicine & Companion Diagnostics, Merck Group
Jeff Shapiro - Partner, King & Spalding
Kim Kaplan - Senior Product Manager, ISACA
16:55 - 17:45
Open Discussion
Open Discussion
09:10 - 09:40
On the Flip Side: Performance Evaluation Requirements under IVDR
On the Flip Side: Performance Evaluation Requirements under IVDR
  • Current regulations for performance evaluations under the IVDR
    • Latest updates & on-going work
    • Differences across regions
  • Key documentation, data points and responsibilities for industry
Khaudeja Bano - VP, Combination Product Quality, Amgen
08:30 - 09:15
Chairperson’s Opening Remarks: Regulatory Affairs in Global Markets: US Region
Chairperson’s Opening Remarks: Regulatory Affairs in Global Markets: US Region
Shikha Malik - Senior Regulatory Affairs Specialist, Medtronic
Chris Bray - Head Global Regulatory Affairs, Precision Medicine & Companion Diagnostics, Merck Group
Jeff Shapiro - Partner, King & Spalding
Kim Kaplan - Senior Product Manager, ISACA
16:45 - 17:45
IVDR Open Forum: Ask the Experts
IVDR Open Forum: Ask the Experts

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!

Patrick Fivey - Director of Precision Medicine Policy, AstraZeneca
08:30 - 08:40
Chairperson’s Opening Remarks: Clinical Evaluations and Investigations & Performance Evaluations
Chairperson’s Opening Remarks: Clinical Evaluations and Investigations & Performance Evaluations
Bassil Akra - CEO, AKRA TEAM GmbH
15:15 - 15:45
Spotlight Session: Navigating Clinical Evaluations & Investigations
Spotlight Session: Navigating Clinical Evaluations & Investigations

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

09:55 - 10:15
US Device Classification
US Device Classification
  • Classification: routes to market
  • Comparison with EU/UK
  • The 513(g) procedure
15:00 - 15:45
Streamlining Biocompatibility Testing Through Evidence Based Toxicology
Streamlining Biocompatibility Testing Through Evidence Based Toxicology
  • Revieing New Approach Methodologies (NAM)
  • Identifying the various types of sensitizers that leach from medical devices
  • Data initiatives tox reports and literature
Ron Brown - Toxicologist, Risk Science Consortium
09:55 - 10:40
Proposed Revisions to ISO 10993-1: Renewed Guidance Recommendations Illustrated Through a Case Study Using a True Risk Assessment Approach for The Biological Safety Evaluation of a Hemodialyzer.
Proposed Revisions to ISO 10993-1: Renewed Guidance Recommendations Illustrated Through a Case Study Using a True Risk Assessment Approach for The Biological Safety Evaluation of a Hemodialyzer.

• Overview of biological risk assessment per ISO 10993-1:2018
• What’s on the horizon for biological risk assessment per revisions that are currently under discussion
• Illustration of biological safety evaluation using a true risk assessment approach through a case study

Crystal D'Silva - Senior Manager, Pre-Clinical Toxicology, Baxter
08:40 - 09:10
Current Playing Field: Clinical Evaluations & Investigations under EU MDR
Current Playing Field: Clinical Evaluations & Investigations under EU MDR
  • Current regulations for clinical evaluations and investigations for devices
    • How do they differ between the UK, Switzerland and the US?
  • Focal points
    • Which areas are under review or in the pipeline?
    • Working plan for agencies
16:15 - 17:00
Hazardous Substances (CMR/ED)
Hazardous Substances (CMR/ED)
  • Dissecting and explaining the requirements of MDR GSPR 10.4
  • Examples of hazardous substances

  • Determination whether hazardous substances are present above 0.1% w/w

  • To Do’s when hazardous substances are present above 0.1% w/w

Christina Reufsteck - Biocompatibility Expert, TÜV SÜD
11:10 - 11:50
Premarket Notifications - 510(k) Clearance
Premarket Notifications - 510(k) Clearance
  • 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
10:10 - 10:40
Expert Session by BSI
Expert Session by BSI
Alex Laan - Head of IVD Notified Body, BSI
11:50 - 12:40
Premarket Approvals (PMA): Devices, IVDs, CDx
Premarket Approvals (PMA): Devices, IVDs, CDx
  • 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
16:15 - 16:55
Manufacture Regulations: 21 CFR 820 Subpart G
Manufacture Regulations: 21 CFR 820 Subpart G
  • Production and process controls
  • Inspection of measuring and test equipment
  • Process validation
09:25 - 10:10
Deep Dive: European Reference Labs (EURLs), Notified Bodies and You
Deep Dive: European Reference Labs (EURLs), Notified Bodies and You
  • Feedback on the status of the reference labs
  • How are Notified Bodies working without them?
  • How many are expected to be designated and by when?
  • Impact on Notified Bodies and manufacturers once designated
  • Working example: IVD approval with EURL involvement
MedTech Summit - Clinical Evaluations and Investigations & Performance Evaluations
08:30 - 08:40
Chairperson’s Opening Remarks: Clinical Evaluations and Investigations & Performance Evaluations
Bassil Akra - CEO, AKRA TEAM GmbH
08:40 - 09:10
Current Playing Field: Clinical Evaluations & Investigations under EU MDR
  • Current regulations for clinical evaluations and investigations for devices
    • How do they differ between the UK, Switzerland and the US?
  • Focal points
    • Which areas are under review or in the pipeline?
    • Working plan for agencies
09:10 - 09:40
On the Flip Side: Performance Evaluation Requirements under IVDR
  • Current regulations for performance evaluations under the IVDR
    • Latest updates & on-going work
    • Differences across regions
  • Key documentation, data points and responsibilities for industry
Khaudeja Bano - VP, Combination Product Quality, Amgen
09:40 - 10:10
Clinical Investigations and Evaluation: How to Ease Transition to MDR
  • Eudamed Clinical Module: overview and status / transparency
  • Clinical investigations and PMCF applications: key insights and harmonized approach?
  • Diversity of clinical data collection?
  • Which improvements from MDCG 2022-14 would be of values to the MDR transition?
Carine Cochereau - , Integra LifeSciences
10:10 - 10:40
Best Practices in the Use of PMCF Surveys
Marcus Torr - PMCF / MDR Lead, Purdie Pascoe
11:10 - 11:55
Data Collection and Sufficiency: What to Collect and What’s Enough?
  • Determining data sufficiency under the MDR & IVDR
    • Are clinical or performance studies always necessary?
    • When can you leverage previous data?
  • Best practices for ensuring sufficient data
Wojciech Bobela - Senior Regulatory Affairs Specialist, Novocure
Ella Helgeman - Regulatory and Quality Director, Rehaler
Nunung Nur Rahmah, M.D., Ph.D - Head of Internal Clinical Team, DEKRA
11:55 - 12:40
Supporting Indirect Clinical Benefits in Clinical Evaluations
  • Overview of Direct vs. Indirect Clinical Benefits and the challenges
  • Defining Safety and Performance Outcomes and Acceptance Criteria for Indirect Clinical Benefits
  • Leveraging Safety and Performance Standards vs. Clinical Literature
Adam Kleinman - Senior Medical Writer, Philips
Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
Golddy Kaur - President, MedTech Regulatory Strategist
14:10 - 14:15
Chairperson’s Afternoon Remarks: Clinical Evaluations and Investigations & Performance Evaluations
Bassil Akra - CEO, AKRA TEAM GmbH
14:15 - 15:15
Harvesting and Using Real-World Evidence (RWE) for Devices & Diagnostics
  • Under which regulations can RWE be used?
    • Is RWE enough on it’s own or does a clinical trial always need to be carried out?
    • Can it be used for both devices and diagnostics?
  • Case studies: suitable RWE for differing risk classes
    • Examples of collection, analysis and use in technical documentation
Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
15:15 - 15:45
Spotlight Session: Navigating Clinical Evaluations & Investigations

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

16:15 - 17:00
An Alternative Perspective: Research-Initiated Studies
  • Determining what is and when to use research-initiated studies
    • Influence of medical staff in initiating studies
    • Benefits of such studies
  • Best practices in fostering working relationships with hospitals
  • Future impact
    • How can utilising research-initiated studies benefit industry and the wider population?
Sara Edvardsen - Research Scientist - Centre for Medical Devices, Technology and Innovation, St. Olavs hospital, Trondheim University Hospital
Shelley Jambresic - Senior Clinical Evaluation Manager, Geistlich Pharma AG
17:00 - 17:45
Ensuring Diverse Representation in Clinical Evaluations & Investigations and Performance Evaluations
  • How diverse is clinical and performance data which is currently being collected?
    • Is diversity covered in regulation?
    • How much obligation is there for collecting diverse data?
    • Availability and usability of diverse data
  • Importance of enhancing diversity moving forward
Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
Maya Balamane - Senior Clinical Scientist, Intuitive
MedTech Summit - Biocompatibility for Medical Devices
09:00 - 09:10
Chairperson’s Opening Remarks: Biocompatibility for Medical Devices
Beau Rollins - Director, Quality Services, ConvaTec
09:10 - 09:55
ISO 10993-1: Expected Changes to the Biological Effects of Medical Devices

The revised draft of the new Part 1 has brought about multiple changes so join us as we discuss its effects on the biological evaluation process.

Jeannette van Loon - CEO, Medical Device Project B.V
09:55 - 10:40
Proposed Revisions to ISO 10993-1: Renewed Guidance Recommendations Illustrated Through a Case Study Using a True Risk Assessment Approach for The Biological Safety Evaluation of a Hemodialyzer.

• Overview of biological risk assessment per ISO 10993-1:2018
• What’s on the horizon for biological risk assessment per revisions that are currently under discussion
• Illustration of biological safety evaluation using a true risk assessment approach through a case study

Crystal D'Silva - Senior Manager, Pre-Clinical Toxicology, Baxter
11:10 - 11:55
1. Material-Mediated Pyrogens in Medical Devices: Myth or Reality? European MedTech Summit.
Kelly Coleman - Toxicologist, Medtronic
11:55 - 12:40
Importance of ISO 10993-12: Test Article Preparation and Extraction Considerations.
  • Proper study design and thorough planning that considers device-specific intricacies in sample preparation is crucial for a successful biological evaluation. Improper sample preparation or extraction conditions can lead to additional evaluation time, testing costs, and animal use.

    In this session, we will discuss some of the main contributing factors associated with:

    • Improper test article preparation.

    • Improper extraction conditions.

Catherine Christensen - Principal Toxicologist, Medtronic
14:10 - 14:15
Chairperson’s Afternoon Remarks: Biocompatibility for Medical Devices
Beau Rollins - Director, Quality Services, ConvaTec
14:15 - 15:00
Moving Forward: ISO 10993-17:2023

With the recent updates and newly revised ISO 10993-1, join us in discussion as we navigate the anticipated effects of these regulatory changes.

Alina Martirosyan - Scientific Manager Toxicology, B Braun
15:00 - 15:45
Streamlining Biocompatibility Testing Through Evidence Based Toxicology
  • Revieing New Approach Methodologies (NAM)
  • Identifying the various types of sensitizers that leach from medical devices
  • Data initiatives tox reports and literature
Ron Brown - Toxicologist, Risk Science Consortium
16:15 - 17:00
Hazardous Substances (CMR/ED)
  • Dissecting and explaining the requirements of MDR GSPR 10.4
  • Examples of hazardous substances

  • Determination whether hazardous substances are present above 0.1% w/w

  • To Do’s when hazardous substances are present above 0.1% w/w

Christina Reufsteck - Biocompatibility Expert, TÜV SÜD
17:00 - 17:45
Regulatory Panel Q&A
  • Meeting regulatory expectations in biocompatibility testing for medical devices

  • Biocompatibility challenges during MDR certification of legacy devices.

  • Addressing the “gap’ between regulatory expectations and industry practices

Christina Reufsteck - Biocompatibility Expert, TÜV SÜD
Jeannette van Loon - CEO, Medical Device Project B.V
MedTech Summit - In Vitro Diagnostic Regulations
08:30 - 08:40
Chairperson’s Opening Remarks: In Vitro Diagnostic Regulations
Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
08:40 - 09:25
Class D The Latest News: Conformity Assessments and Common Specifications
  • Conformity assessments for Class D
    • Current requirements from Notified Bodies
    • Challenges for manufacturers
  • A focus on current common specifications
    • What changed within the new version?
    • How much effect does this change have on industry?
    • How are notified bodies ensuring compliance to these specifications?
Tommy McDonagh - Associate Director Regulatory Affairs (IVDR), Abbott Core Diagnostics
09:25 - 10:10
Deep Dive: European Reference Labs (EURLs), Notified Bodies and You
  • Feedback on the status of the reference labs
  • How are Notified Bodies working without them?
  • How many are expected to be designated and by when?
  • Impact on Notified Bodies and manufacturers once designated
  • Working example: IVD approval with EURL involvement
10:10 - 10:40
Expert Session by BSI
Alex Laan - Head of IVD Notified Body, BSI
11:10 - 11:55
Shared Experiences: Leveraging Data from Previous Submissions
  • With reference to MDCG 2022-14, is leveraging data a falsehood?
    • When can data be leveraged or when is new data collection necessary?
    • Which data could be leveraged?
    • Could it be leveraged for devices of all classes?
  • Case study: unsuccessful use of previous data and lessons learnt
  • Tips for future leveraging attempts
Heike Moehlig-Zuttermeister - Director Expertise Management & Segment Manager IVD, TÜV SÜD
11:55 - 12:40
The Impact of IVDR for Health Institutions

What is the practical impact of IVDR for health institutions, both when new CE-IVD kits come onto the market and when CE-IVD kits are (temporarily) taken off the market? Where can health institutions collaborate with industry to increase patient safety?

Elizabeth Dequeker - Head of the Biomedical Quality Assurance Research Unit, University of Leuven
14:10 - 14:15
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Regulations
14:15 - 14:45
Spotlight Session: Navigating In Vitro Diagnostic Regulations

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

14:45 - 15:15
Cross-Industry Learning: The Impact of IVDR on the Pharmaceutical Industry
  • Potential Shortages of Commercially Available tests and an expected reduction in labs able to use IH-IVDs (LDTs for routine testing purposes with Precision Medicines
  • Potential delays in clinical trials of Precision Medicines using IVDs with a medical purpose.
Patrick Fivey - Director of Precision Medicine Policy, AstraZeneca
15:15 - 15:45
Clinical Trials & Pharma: Assessing the Impact of the IVDR
  • What is the impact of IVDR on the ability to enroll patients into trials?
    • How is IVDR impacting trials that have patient selection and further what is the impact to inclusion/exclusion and assays/data used for medical management?
    • How is country by country variability impacting trials and how divergent are the various opinions?
  • What is the expected impact of the US LDT regulations and what is different/the same to IVDR?
  • What infrastructure is needed to support these changes for drug developers, sites and laboratories?
  • Have laboratories managed to meet the requirements of IVDR and what are the current gaps?
  • What infrastructure does the industry need to build for a better future state?
Kristina McGuire - Executive Director and Head, Precision Medicine Laboratory Operations and Companion Diagnostics, Regeneron
16:15 - 16:45
Adhering to PMS Vigilance Requirements: EU vs UK
  • Current requirements for adverse events, FSCAs and trend reporting
  • Similarities and differences across regions
  • UK Case study: filing an adverse event on new MORE Web Portal
    • Differences between UK & Northern Ireland
Laurent Oliviero - Complaint Handling Specialist 4, QuidelOrtho
16:45 - 17:45
IVDR Open Forum: Ask the Experts

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!

Patrick Fivey - Director of Precision Medicine Policy, AstraZeneca
MedTech Summit - Regulatory Affairs in Global Markets: US Region
08:30 - 09:15
Chairperson’s Opening Remarks: Regulatory Affairs in Global Markets: US Region
Shikha Malik - Senior Regulatory Affairs Specialist, Medtronic
Chris Bray - Head Global Regulatory Affairs, Precision Medicine & Companion Diagnostics, Merck Group
Jeff Shapiro - Partner, King & Spalding
Kim Kaplan - Senior Product Manager, ISACA
09:15 - 09:55
Overview of US FDA Regulation of Medical Devices
  • 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 discprepancies
  • 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
09:55 - 10:15
US Device Classification
  • Classification: routes to market
  • Comparison with EU/UK
  • The 513(g) procedure
10:15 - 10:40
The Q-submission 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
11:10 - 11:50
Premarket Notifications - 510(k) Clearance
  • 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
11:50 - 12:40
Premarket Approvals (PMA): Devices, IVDs, CDx
  • 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
14:10 - 14:20
Chairperson’s Afternoon Remarks: Regulatory Affairs in Global Markets: US Region
Shikha Malik - Senior Regulatory Affairs Specialist, Medtronic
Chris Bray - Head Global Regulatory Affairs, Precision Medicine & Companion Diagnostics, Merck Group
Jeff Shapiro - Partner, King & Spalding
Kim Kaplan - Senior Product Manager, ISACA
14:20 - 15:10
Product Development US Style
  • 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
15:10 - 15:45
Quality System Regulation: 21 CFR 820
  • 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
16:15 - 16:55
Manufacture Regulations: 21 CFR 820 Subpart G
  • Production and process controls
  • Inspection of measuring and test equipment
  • Process validation
16:55 - 17:45
Open Discussion
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