Day One – 10 June 2024Monday, 10 June 2024 - CEST (Cent Europe Summer, GMT+2)

08:00 - 08:30

Conference Registration

Showing 3 of 3 Streams

European Medical Device Regulations

Medical Device Law and Compliance

In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation

08:30 - 08:40

Chairperson’s Opening Remarks: European Medical Device Regulations

Gert Bos - Executive Director & Partner, Qserve Group

08:40 - 09:40

EU MDR: Timelines, Transitions and Tribulations

Recap of deadlines – who needs to have certified what and by when?
Have the extensions solved notified body and manufacturer capacity concerns?
Have the transition deadline extensions improved the outlook for device certification in Europe?
Further regulatory developments potentially impacting the fluidity of transition

Gert Bos - Executive Director & Partner, Qserve Group
Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
Martin Witte - Senior Director Strategic Business Development, TÜV SÜD Product Service GmbH
Flora Giorgio - Acting Head of Unit, D.3 Medical Devices, DG SANTE, European Commission

09:40 - 10:10

UKCA State of Play

With the regulation being implemented in July 2025, what do we know about the intended regulations?
How closely aligned are UK regulations and submissions process to EU MDR and MedDO?
What should all stakeholders be doing to prepare for the implementation of these regulations?

Ashleigh Batchen - Regulatory Strategy Principal (UK), TÜV SÜD

10:10 - 10:40

Medical Devices and the Swiss Market in 2024

Current regulations for approval and timelines for acceptance
Regulation revisions currently on-going or scheduled
Mutual Recognition Agreement (MRA)

Daniel Delfosse - Executive Board Member, Director Regulatory Affairs, Swiss Medtech

09:00 - 09:10

Chairperson’s Opening Remarks: Medical Device Law and Compliance

Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited

09:10 - 09:40

DUAL DIALOGUE What does the Artificial Intelligence (AI) Act Mean for Medical Devices and IVDs

Reconciling the requirements in the IVD, MDR and guidance under the umbrella of the proposed AI Act?
Considerations for users of AI Systems as the proposed AI Act extends to users
Overlaying European proposals with US frameworks for AI and the implications for global policies
Practical implications and legal considerations for MedTech and IVD manufacturers

Agnes Szoboszlai - Regulatory Legal Counsel, Philips
Sarah Cowlishaw - Partner, Covington & Burling LLP

09:40 - 10:10

DUAL DIALOGUE Navigating Data Frameworks and European Health Data Space (EHDS)

Analysing crucial legal frameworks influencing your data landscape: delving into the EHDS, the Digital Data Act, and the Data Act
Navigating the EHDS: unveiling challenges and opportunities for the MedTech and IVD industry and lessons from the pharmaceutical industry
What types of data are appropriate for inclusion in EHDS and where should the line be drawn for commercially sensitive data?
Safeguarding commercially confidential data: assessing the adequacy of Intellectual Property (IP) protection in the ever-evolving data landscape

Roberto Girardi - Senior Director, Global Head of Privacy Compliance & Risk Management, ResMed
Nathalie Poupaert - Counsel, Technology & Data, Fieldfisher

10:10 - 10:40

DUAL DIALOGUE Decoding the Impact of Enhanced Cyber Security Regulations for Medical Devices and IVDs

Overview of regulatory frameworks: Cyber Resilience Act (CRA), NISD2, and Critical Entities Resilience Directive (CER)
Analysis of implications for internet-enabled devices
Strategic guidance on navigating the heightened regulatory burden imposed by new regimes including the US cyber security rules

Alison Dennis - Partner, Taylor Wessing
Paula Antunes - Global Regulatory Lead, GRA - RA Digital Health & IVD, Novo Nordisk

09:00 - 09:10

Chairperson’s Opening Remarks: In Vitro Diagnostic Workshop

Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
Liz Gommans - Technical Professional, DEKRA
Catherine Holzmann - Certification Division Manager In Vitro Diagnostics Medical Devices, GMED

09:10 - 10:40

The Pre-Application Phase

Structure of a Technical Documentation file
Notified Body code assignment
Classification
Creation of sampling groups

10:40 - 11:10

Coffee and Networking Break

Showing 3 of 3 Streams

European Medical Device Regulations

Medical Device Law and Compliance

In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation

11:10 - 11:40

What’s Past is Prologue: The Evolution (and Future) of AI and Content Automation

Content automation technologies have been developing for 70 years – MDR and IVDR have accelerated this development, as well as adoption across the device industry. And, while product-related applications for artificial intelligence (AI) generate attention-grabbing headlines, the larger (and more certain) financial benefits are in process-related applications.
How are translation AI and process automation software (CCMS, TMS) converging to automate content creation, translation and publication of device and IVD content in multi-channel format?
The recently-adopted EU AI Act specifies penalties of up to 7% of global revenue for violation…what impact will this new regulation and ISO 42001 have for device makers?

Marc Miller - Division President, TransPerfect Medical Device Solutions, TransPerfect Medical Device Solutions

11:40 - 12:10

The Forgotten Devices: Regulating Orphan Devices

Current status for regulating such devices under the MDR
Have, and why, are orphan devices being overlooked?
Vitality of orphan devices for the wider public
Current work to improve certification

Robert van Boxtel - Principal Consultant, Medical Device Project B.V

12:10 - 12:40

Moving Towards a Global View: Technical Regulatory Approach to Support Design Projects and Market Authorisations

IMDRF
MDSAP
National / Regional Regulations
The benefits of a global holistic and strategic pre-market device development and post market device life-cycle approach

David Bottom - Standards Compliance Manager, Intersurgical

11:10 - 11:40

DUAL DIALOGUE Where to Launch? Comparison of EU CE Mark with UK CA and the Swiss CE Label

Review of UK CA mark: when might it be advantageous to certify in the UK? Considerations for software and existing legacy MDD certified devices
Implications of the UK move to join MDSAP
New international recognition regimes in the UK extending to approvals in the US, Japan and other countries
Examining the effects of the Swiss foreign recognition pathway

Darren Thain - Director, Global Regulatory Affairs Policy and Intelligence, Smith & Nephew
Alex Denoon - Partner, Bristows LLP

11:40 - 12:10

DUAL DIALOGUE Advantages and Challenges of UK Innovative Device Alternative Pathway (IDAP)

UK framework to accelerate the development and deployment of innovative medical devices
Developments for Mutual Recognition Agreements
How will the MHRA approach issuing temporary approvals?
Legal (including IP) considerations for regulatory submissions and pricing authority approvals
Opportunities and disadvantages of IDAP when considering where to launch
Will the EU Commission adopt a similar framework in the planned revision of MDR and IVDR?

Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
Alex Denoon - Partner, Bristows LLP

12:10 - 12:40

DUAL DIALOGUE The Liability Risks and Implications of Regulatory Failings

Examining the current state of play in product liability litigation
Regulatory failings as evidence of product defect
How changes to the existing regulatory frameworks might give rise to an increased liability risk

Samantha Silver - Partner, Kennedys
Nathalie Smyth - Partner, Kennedys

11:10 - 12:40

Directive to Regulation Data

Completion of a gap assessment
Tips to score with your NB
State of the art concept

12:40 - 14:10

Networking Luncheon

Showing 3 of 3 Streams

European Medical Device Regulations

Medical Device Law and Compliance

In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation

14:10 - 14:15

Chairperson’s Afternoon Remarks: European Medical Device Regulations

Eljar Amini-Nejad - Client Solutions Senior Consultant EMEA, NSF Medical Device & IVD Consulting

14:15 - 15:00

A Guide to Material Compliance: How to Successfully Navigate GSPR 10.4 CMR/ED Substances

Industry Perspective
Obligations of medical device manufacturers
Justification for continued use
Implementation and Practical Issues & Examples

Renate Reiss - Associate Director Regulator Affairs & Compliance, Institut Straumann AG

15:00 - 15:45

Economic Operators and Supply Chains: Ensuring Compliance Throughout

Role of economic operators in the overall supply chain
How do they affect international registrations?
Handling supply chain kinks
Overcoming issues to maintain device compliance
Best practices to enhance supply chain security

Svetlana Bykanova - Senior Vice President, Global Quality and Compliance, HOYA Surgical Optics

14:10 - 14:15

Chairperson’s Afternoon Remarks: Medical Device Law and Compliance

Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited

14:15 - 15:15

DUAL DIALOGUE IVDR Developments for Companion Diagnostics: From Clinical Trials and Regulatory Approval to Reimbursement

Understanding IVDR regime for companion diagnostics
Reconciling the requirements of IVDR and the EU Clinical Trials Regulation
Commercial and IP considerations when pharmaceuticals are combined with devices and companion diagnostics
Practical challenges of reimbursement for companion diagnostics

Josefine Sommer - Partner, Sidley Austin
Ioana Ratescu - Head Legal Global Regulatory, Novartis

15:15 - 15:45

DUAL DIALOGUE Legal Recourse: What to Do When your Competitor Breaks the Rules

Different areas of focus and best options including EU MDR accountability, Industry Codes of Conduct, Freedom of Information requests and Notified Bodies
Challenging competitor CE Marks based on non-compliance and safety concerns: interacting with Notified Bodies, Competent Authorities, customers and Courts
Competition Law considerations in light of ongoing Commission investigations regarding allegations of abuse of dominance
Practical case scenarios and worked examples

Michele Boggiani - Director, Global Legal Lead, Galderma
Jacqueline Mulryne - Partner, Arnold & Porter

14:10 - 14:15

Chairperson’s Afternoon Remarks: In Vitro Diagnostic Workshop

Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
Liz Gommans - Technical Professional, DEKRA
Catherine Holzmann - Certification Division Manager In Vitro Diagnostics Medical Devices, GMED

14:15 - 15:45

Performance Evaluation and Clinical Evidence

How to demonstrate Performance Evaluation and Clinical Evidence

15:45 - 16:15

Coffee and Networking Break

Showing 3 of 3 Streams

European Medical Device Regulations

Medical Device Law and Compliance

In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation

16:15 - 16:45

Curating a New Perspective: From ‘Sick Care’ to ‘Health Care’

Investing in health care to create resilient and sustainable health care systems
- Avoiding wastage in health spending
Facilitating more precise patient pathways
- Utilising diagnostic equipment, medtech innovations and health data
- Impact of such in reducing inequalities and lack of health literacy

Jurate Svarcaite - Director General, Association of the European Self-Care Industry (AESGP)

16:45 - 17:45

Multi-Stakeholder Perspective: The Impact of the MDR on Innovation & Industry

How is the MDR impacting innovation in Europe?
- Are there pathways which innovators can use to expedite market access?
- How do innovation pathways in Europe compare to other regions?
Future of industry

Bassil Akra - CEO, AKRA TEAM GmbH
João Martins - Associate Director Regulatory Affairs Strategy, Abbott
Martin Witte - Senior Director Strategic Business Development, TÜV SÜD Product Service GmbH
Melanie Donguy - Head Regulatory Affairs Radiology Medical Devices EMEA, Bayer

16:15 - 16:45

Preparing for the European Product Liability Directive

How will the EU’s Product Liability Directive 85/374/EEC sit alongside new laws on the liability of AI systems and the new class action mechanism
How will key changes affect the MedTech industry and strategies to ensure you are prepared
Analysing liability for importers, authorised representative, manufacturers
Interpreting the new expanded definition of defect

Fabien Roy - Partner, Hogan Lovells
Matthias Schweiger - Partner, Hogan Lovells

16:45 - 17:45

DUAL DIALOGUE Legal Advice and Avoiding Common Trip Points for Medical Device Commercial Transactions

Practical advice on how to prepare for an M&A transaction: considerations for buyers and sellers
Sharing best practice and common mistakes in M&A transactions in the MedTech sector
Examining the restrictions imposed by the Article 120 transitional provisions
Implementation considerations including changing economic operators and PRRCs

Annabelle Bruyndonckx - Partner, Simmons & Simmons LLP
Pierre-Alexis Maingon - Supervising Associate, Simmons & Simmons

16:15 - 17:45

Clinical Evidence (continued) and Post Market Surveillance

IVDR requirements & NB expectations

17:45 - 17:50

Close of Day One

Day One – 10 June 2024Monday, 10 June 2024 - CEST (Cent Europe Summer, GMT+2)

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