Day Three – 18 June 2025 - CEST Time Zone
- Bassil Akra - CEO, AKRA TEAM GmbH
investigations?
Which new guidances have been released?
Which areas are working best and which need further reform?
Future vision
What's in the pipeline for H2 2024 and beyond?
Are there big updates which industry could prepare for now?
- Nebojsa Serafimovic - Assessor for Clinical Investigations, Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
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
What does the latest revision to ISO 10993-1 really mean for you?
What are the biggest changes between versions?
What do manufacturers and testing facilities need to do differently?
Case study example of adhering to –1 before and after revision
- Jeannette van Loon - Member, ISO TC 194 WG1
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
In these 15 minutes before the break, take the time to reflect on your current biocompatibility 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
include?
How does this interact with other pre-existing medical device and ESG legislation?
MDR
Batteries
REACH
- Current adoption status
- Best practices to ensure readiness to comply
With Product Liability Directive 85/374/EEC having been adopted, what does this mean for medical device manufacturers?
What’s changed and what does it mean for liability looking ahead?
How does the directive interact/overlap with other regulations (eg MDR; AI Liability Directive; RAD)?
What should manufacturers be doing now to prepare?
- Harriet Hanks - Counsel, Freshfields Bruckhaus Deringer
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
- Gert Bos - Executive Director & Partner, Qserve Group
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
- Abhineet Jhori - Regulatory Affairs Manager, Siemens Healthineers
- Abtin Rad - Global Director Functional Safety, Software and Digitization, TÜV SÜD
- Leon Doorn - QAIR.io, Independent Regulatory Affairs Consultant
With so much buzz around the EU AI Act, what actually is it and why is it so important for industry?
Does it only affect manufacturers with AI-enabled devices?
Is it already implemented and are there transition times?
What implications are there for industry, notified bodies and regulators?
The regulatory landscape before the introduction of the EU AI Act vs now
Which regulations do manufacturers need to be aware of in addition to the EU AI Act?
How does the Act interact with EU MDR/IVDR, as well as data protection regulations?
With the UK moving further along in their regulatory journey, what clinical regulations are there for manufacturers?
Do they align closely with those of Europe, or other regions?
Are approved body expectations similar to notified bodies?
Implications for industry
Can data be used cross-regionally?
Comparison of documentation requirements between UK and EU
2 years since the project was launched, what are the current findings?
Which key challenges have been indentified?
Are there proposed solutions?
The future of the project
Next priorities and steps
- Benedicte Nuyttens - Scientific File Manager, Federal Agency for Medicines and Health Products (FAMHP)
- Fatima Sanfourche - Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
One of the key revisions for –1 centres around genotoxicity, but what does this mean?
Which groups is this endpoint applicable to now?
Why has this change materialised?
What does this increased evaluation mean for wider public health?
- Best practices for applying genotoxicity to those who have not previously
- Crystal D’Silva - Preclinical Technical Lead/Associate Director, Baxter
With –17 having been in place for 1 year, what are industry’s first experiences of adhering to the standard?
Are there differences in EU and FDA acceptance?
Can we expect further alignment?
Which parts are causing the most confusion?
Possible solutions to ease working under -17
- Kim Ehman - Technical Director of Regulatory Toxicology, WuXi AppTec
- Roberto Girardi - Senior Director, Global Head of Privacy Compliance & Risk Management, ResMed
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
Does the AI Act describe data requirements?
Which evidence is required for certification under the Act?
How does this interact with data requirements from other regulations?
Does it differ based on device risk class?
How do you know if it is sufficient?
Collecting suitable data: a working example
- Bassil Akra - CEO, AKRA TEAM GmbH
Following Articles 78 MDR/74 IVDR a coordinated assessment procedure for clinical investigations and performances studies should be provided.
Solutions without Eudamed
Purpose of the pilot
Intended outcomes
Current status
Current procedure
Are there any current learnings from the pilot?
How will this pilot pave the way for future mandatory implementation?
- Benedicte Nuyttens - Scientific File Manager, Federal Agency for Medicines and Health Products (FAMHP)
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
- Jianwei Li - Chemical Characterization Consultant and Technical Writer, Chemical Characterization Solutions, LLC
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
A year on from the decision by the Hanseatic Higher Regional Court Hamburg (OLG Hamburg, file reference: 3 U 3/24) regarding telemedicine app – where are we now?
Competition law and advertising considerations
How can this situation be avoided?
Importance of accurate qualification and classification of software and apps
- Hilary Jones - Vice President Legal - Global Commercial and Regulatory Law, BioNTech UK Limited
- Michele Boggiani - Director, Global Legal Lead, Galderma
- Jacqueline Mulryne - Partner, Arnold & Porter
- Gert Bos - Executive Director & Partner, Qserve Group
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
- Abhineet Jhori - Regulatory Affairs Manager, Siemens Healthineers
- Leon Doorn - QAIR.io, Independent Regulatory Affairs Consultant
- Abtin Rad - Global Director Functional Safety, Software and Digitization, TÜV SÜD
How does the EU AI Act interact with post-market surveillance and vigilance requirements?
Are there additional requirements which need to be considered?
How do you monitor post-market for non-static devices and diagnostics?
Are there any regulations or frameworks around ethics for AI, including in the EU AI Act itself?
What ethical considerations need to be taken into account?
Algorithm transparency and bias
Data protection and security
Defining the State of the Art (SotA)
Why the SotA is important and how it can be leveraged by MedTech business functions
What business functions can benefit from an early SotA
Role of SotA in the CEP and CDP
How conducting the CEP early in the design process assists design and development
Keeping up with times: continuous evolution of the SotA and the clinical evaluation
- Adam Kleinman - Sr. Manager, Clinical Compliance, Philips
- Kevin Melody - Senior Medical Writer, Philips
- Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
How are notified bodies assessing clinical and performance evidence on manufacturers?
Are expectations aligned?
Is there further work going into harmonising expectations?
Can industry help in harmonisation efforts?
- Nunung Nur Rahmah, M.D., Ph.D - Head of Internal Clinical Team, DEKRA
- Shelley Jambresic - Group Lead Science & Evaluation, Geistlich Pharma AG
- Nataliya Deych - Vice President Regulatory Affairs EMEA, Latam, Canada, Edwards Lifesciences
- Carine Cochereau - Regulatory International (OUS) Vice President, Integra Lifesciences
- Erman Melikyan - Principal Clinician, Intertek
- Boopathy Dhanapal - Convener of ISO/TC 194 WG 18, Independent Consultant
What are these updates?
Are there any impacts for manufacturers?
Do biological evaluations and modalities need to be revised?
Which alternatives are available, and should we consider using them?
- Beau Rollins - Global Director, Quality Services, ConvaTec
Summary of the case
Process of original ruling and subsequent appeal
Grounds of appeal
Outcome of case for both RRR and BSI
Lessons to takeaway for manufacturers and notified bodies
- Alex Denoon - Partner, Bristows LLP
- Darren Thain - Director, Global Regulatory Affairs Policy and Intelligence, Smith & Nephew
From a legal perspective, what is the state of play and what are the main elements of new proposals?
Where will the respective proposals take us and are they a route forward?
What would it mean for all stakeholders if the proposals are adopted and do they solve all problems?
- Erik Vollebregt - Partner, Axon Lawyers
Take this time to put together a mock submission for a device in line with the Act
Compare and contrast with other workshop participants and gain invaluable feedback from trainers
Open Q&A