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
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?
- In these 15 minutes before the break, take the time to reflect on your current EU MDR 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
- 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
Key changes and implications for SMEs
Understanding the regulatory classification system
Criteria for choosing a notified body
The role of the notified body in the regulatory process
- 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
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
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: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
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 - Executive Board Member, Director Regulatory Affairs, 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?
Essential components of the technical file
Best practices for documentation and evidence generation
How to curate a regulatory and clinical strategy from the ground up
Understanding the key elements of the metrological traceability concept described in ISO 17511
Learning why global test standardization (first choice) or harmonization (second best) should be accomplished in laboratory medicine
Learning about the rationale for global medical test (panel) standardization/harmonization and its strategic importance for the EHDS
- Christa Cobbaert - Head of Department of Clinical Chemistry, Leiden University Medical Center
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
- 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?
- Alice Forde - Director, Regulatory Affairs Europe, Bausch & Lomb
- Bassil Akra - CEO, AKRA TEAM GmbH
- 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
Identifying target markets and customer segments
Assessing market potential and competitive landscape
Understanding reimbursement pathways in different European countries
Developing effective pricing strategies
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
- Lakshman Ramamurthy, PhD - Vice President, Regulatory Affairs, GRAIL
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
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
- João Martins - Associate Director Regulatory Affairs Strategy, Abbott
- Nataliya Deych - Vice President Regulatory Affairs EMEA, Latam, Canada, Edwards Lifesciences
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
- Christina Ziegenberg - Deputy Managing Director, BVMed
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
Overview of funding options (e.g., grants, loans, venture capital, private equity)
Developing a compelling investment pitch
Navigating the fundraising process
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 - Associate Director Regulatory Affairs Strategy, 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
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina