Day One – 16 June 2025 - CEST Time Zone
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
With the first set of deadlines now only months away, how are all stakeholders coping?
Are notified bodies keeping up with submissions?
Are manufacturers submitting in time?
Current European outlook
Does Europe look to be in a better shape, having extended the transition deadlines?
Which areas are still causing concern?
Proposals for ensuring European healthcare continues moving forward
- Bassil Akra - CEO, AKRA TEAM GmbH
- Giacomo Cargnello - Head of Quality Assurance & Regulatory Affairs, C&C Solutions, Varex Imaging
- Mira Leiwant - Vice President, Regulatory Affairs, Quality, and Clinical Affairs, Anika Therapeutics, Inc.
What is the latest news on UK regulations for medical devices?
What do we know in terms of alignment with Europe, Switzerland and beyond?
Will manufacturers have transition times and what are the proposed dates?
What can manufacturers do now to prepare?
- Robert Reid - Deputy Director, Innovative Devices, Medicines and Healthcare Products Regulatory Agency (MHRA)
- Roles of economic operators in PMS and vigilance
- Useful contractual provisions
- Additional obligations for devices including AI
- Alison Dennis - Partner, Taylor Wessing
- Tom Patten - IVDR/IVD International Manager, GMED
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Robert Paassen - Consultant, Qserve
- Elem Ayne - President, TEAM-PRRC
- Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
- EU vs US
- Identifying target markets and customer segments
- Assessing market potential and competitive landscape
- How to curate a regulatory and clinical strategy from the ground up
- Robert Paassen - Consultant, Qserve
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Arjun Amin - Chief Operating Officer, EyeSpace
- Key changes and implications for SMEs
- Understanding the regulatory classification system
- Robert Paassen - Consultant, Qserve
- Tom Patten - IVDR/IVD International Manager, GMED
- Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
With the transition deadlines approaching fast for all diagnostic risk classes, how are we progressing in certifying IVDs under the IVDR?
Impact of 2024/1860
Has the new transition times alleviated capacity and transition concerns?
Which areas still remain a pain point and what steps are in place to aid this?
Current regulatory status and Commission’s priorities for the next year
- Rob Laport - Project Manager and Certification Manager Medical Devices, DEKRA Certification B.V.
Latest news on the regulatory pathway to Switzerland
The role of the CH-REP
Status of acceptance of FDA-products
Status of the MRA EU-CH
Priorities for 2025
- Daniel Delfosse - Vice Director, Head of Regulation & Innovation, Swiss Medtech
Since the Battery Regulation was released in July 2023, how have manufacturers been coping with adhering to the new regulation?
How does it tie in with the overall MDR?
How are notified bodies assessing batteries in devices?
What is the wider impact on public health?
- Amelie Chollet - Partner, CMS Cameron McKenna Nabarro Olswang LLP
The MedTech industry is facing an increasingly complex regulatory environment, with recent updates like the EU MDR, EU IVDR, and the FDA's shift toward ISO 13485 requiring rapid compliance adjustments. Traditional, siloed systems often impede efforts to keep up, as many manufacturers have historically focused on physical products rather than embracing digital innovation. With emerging priorities such as Software as a Medical Device (SaMD), cybersecurity, and sustainability, MedTech companies must adapt quickly or risk falling behind. As regulatory updates become more frequent, digital transformation and real-time traceability are no longer optional—they’re essential for staying competitive. This session will explore practical strategies for navigating these challenges, balancing compliance with innovation, and ensuring sustained success in MedTech. Attendees will gain actionable insights on rethinking strategy and embracing digital solutions to meet evolving regulatory demands, stay competitive, and go to market faster.
Attendees will learn actionable strategies for navigating the complex regulatory landscape and driving digital transformation, ensuring MedTech companies stay compliant, competitive, and innovative in a rapidly evolving market and ultimately go to market faster.
- Guido Banning - Technical Account Manager, Fellow, PTC
- Criteria for choosing a notified body, consultant, and Person Responsible for Regulatory Compliance (PRRC)
- The role of each supplier in the regulatory process
- Elem Ayne - President, TEAM-PRRC
- Tom Patten - IVDR/IVD International Manager, GMED
- Robert Paassen - Consultant, Qserve
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Arjun Amin - Chief Operating Officer, EyeSpace
- Why do i need a QMS?
- EU vs US
- How to build an efficient and sustainable QMS
- Best practices for keeping it lean
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Elem Ayne - President, TEAM-PRRC
- Arjun Amin - Chief Operating Officer, EyeSpace
- Robert Paassen - Consultant, Qserve
- Tom Patten - IVDR/IVD International Manager, GMED
With EURLs now being designated, what can we expect for IVD approvals?
Which diagnostics are affected?
How does this change working processes for manufacturers, notified bodies and regulators?
Working example: certifying IVDs with the involvement of EURLs
- Heike Möhlig-Zuttermeister - Global Director in-vitro Diagnostics (IVD), TÜV SÜD
After so many years of anticipation, has industry finally got the answers to their UK questions?
How will IVDs be regulated within the UK?
How does this compare to EU?
How can they streamline workload for both regions?
- Steve Lee - Director, Diagnostics Regulation, ABHI
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
With Article 10a now having been in place for a few months, what initial learnings are there?
Is guidance clear on responsibilities?
Are there any common pain points arising from the process?
Are there any further plans to further reform the process for shortages?
- Bassil Akra - CEO, AKRA TEAM GmbH
- Alice Forde - Senior Director, Regulatory Affairs – Vision Care, Bausch & Lomb
- Melanie Donguy - Head Regulatory Affairs Radiology Medical Devices EMEA, Bayer
- Darren Thain - Director, Global Regulatory Affairs Policy and Intelligence, Smith & Nephew
- Be a Success-Enabler
- Secure a Place at the Table as a Full Partner
- Better Processes Produce Better Products
- Peter Shearstone - Vice President, Global Quality & Regulatory Affairs, Thermo Fisher Scientific
- Arjun Amin - Chief Operating Officer, EyeSpace
- Tom Patten - IVDR/IVD International Manager, GMED
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Robert Paassen - Consultant, Qserve
- Elem Ayne - President, TEAM-PRRC
- Essential components of the technical file
- Best practices for documentation and evidence generation
- Tom Patten - IVDR/IVD International Manager, GMED
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Robert Paassen - Consultant, Qserve
- Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
- Rolf Thermann - Section Manager IVD and Companion Diagnostics Lead, TUV Rhineland
- Vihanga Pahalawatta - Director Regulatory Affairs Companion Diagnostics, AbbVie
New regulatory frame in Europe - MDR challenges for all the stakeholders
Compliance strategies to fulfil the requirements – ROBUST RECEPTION
Lessons learned from our experience
- Cristina Miroescu - Compliance Director, SOFMEDICA GROUP
- Katerina Pappa - Regulatory and Compliance Manager, SOFMEDICA GROUP
Reflecting on the MDR journey so far, how efficient is the current process?
Which processes cause the most delays in product certification?
Future reform: how can efficiency be improved?
Use of digital tools and AI
Multistakeholder collaboration
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
- João Martins - Director Regulatory Affairs., Abbott
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
- Christina Ziegenberg - Deputy Managing Director, BVMed
- Carmen Ruiz-Villar Fernandez-Bravo - Deputy Director, Medical Devices Department, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
- Funding
- Overview of funding options
- Creating a compelling investment pitch
- Entry to Markets
- What problem are you trying to solve?
- Key Market Drivers
- Why this product? Why now?
- Arjun Amin - Chief Operating Officer, EyeSpace
- Arjun Amin - Chief Operating Officer, EyeSpace
- Tom Patten - IVDR/IVD International Manager, GMED
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Elem Ayne - President, TEAM-PRRC
- Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
- Robert Paassen - Consultant, Qserve
What actually classifies as a structured dialogue under IVDR?
Who can have one?
What can be discussed during one?
What do they aim to achieve?
Current experiences with structured dialogues and lessons learned
Best practices for getting the most out of them
- João Martins - Director Regulatory Affairs., Abbott
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
With IVDR having been in place for a few years, what are industry’s current experiences of managing portfolios?
How do they manage cyclical workload for all diagnostics?
What are their tips for optimising and streamlining workload?
Risk and mitigation strategies for anticipating regulation changes
- Ranka Milojkovic - Principal Project Manager, Quality, Abbott