Day 2 - CET/CEST (Cent Europe Summer, GMT+2)
Day 2 - CET/CEST (Cent Europe Summer, GMT+2)
- Alex Charitou - Partner, MedTech Lead, EY
- What to do if the device has no direct effect on the patient?
- How to identify gaps in evidence?
- What can be discussed with the Notified Body and what does leveraging clinical evidence mean?
- What guidance and standards for clinical evidence is coming?
- How to structure clinical evidence?
- What to do if there is not sufficient clinical evidence?
- Leo Hovestadt - Director Governmental Affairs EU, Elekta, The Netherlands
- Identifying audit essentials
- Required data and documentation for audits
- Common questions
- Best practices for audit planning
- Holger Wagner - Head of Regulatory Affairs - Business Unit Hospital Consumables & Accessories, Medical Division, Drägerwerk AG & Co. KGaA
- Classification of substance-based devices
- What falls under this category under the MDR?
- Identifying mechanism of action
- Working with Notified Bodies in certification process
- Sufficient clinical data
- Documenting intended purpose
- Route to market
- Daniele Bollati - Product Conformity Assessment, IMQ
- Where we are now
- Implementation of the new regulations
- Is biological safety assessment changed?
- Sophie Clewlow - Biological Safety Assessor, MHRA
- MDR Requirements of CMR/ED substances for the MDR and how this relates to ISO 10993-1, -18 and -17
- Risk justification and the use of SCHEER guidelines on the benefit-risk assessment of CMR/ED substances
- Labelling
- Jeannette van Loon - CEO, Medical Device Project B.V. (MDProject)
- EU MDR and sensitizing substances. Absence of data is not absence of risk.
- Real cases where skin problems have occurred after exposure to medical devices.
- Does PMS data actually demonstrate a history of safe use?
- Monica Grekula - Director Biocompatibility and Toxicology, Limulus Bio AB (Now part of Veranex)
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - IVDMD Department Manager - GMED Certification Division - France, LNE/G-MED
- Structure of a Technical Documentation file
- NBOG code assignment
- Classification
- Creation of sampling groups
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - IVDMD Department Manager - GMED Certification Division - France, LNE/G-MED
- Current status
- How many health systems are involved?
- Integration status
- Interaction with EU MDR, UKCA and Swiss
- Paving the way
- Next steps in integration
- Future implications on healthcare industry and patient care
- Cécile van der Heijden - Attorney at Law, Axon Lawyers
- Background and definitions
- Process overview
- Case stories and examples
- Considerations to make when identifying the right outcome parameters
- Helene Quie - CEO, Qmed Consulting A/S
- Obligations of medical device manufacturers
- Benefit Risk Assessment (BRA)
- Examples & challenges
- Implementation and Practical Issues
- Raw material specification
- Supplier documentation
- Renate Reiss - Associate Director Regulator Affairs & Compliance, Institut Straumann AG
- Same – not the same; how to deal with changes regarding raw materials, suppliers, processes
- Is testing always the right approach? Ways to escape from checklist procedure
- How to integrate the biological evaluation in your change management process.
- Marco Costante - Group Leader – Human Health, Environmental & Human Toxicology, knoell Germany GmbH
- Best approach to gain authority acceptance of chemical characterisation (CC) data, including CC data in overall biocompatibility evaluation
- Using CC to reach biological endpoints
- Opportunities to reduce regulatory uncertainty and to ensure the high-quality chemical analyses for the toxicological risk assessments
- Marika Kamberi - Sr. Director Analytical Chemistry and Biocompatibility, Abbott Medical Devices
- A proof-of-concept study using the GARDskin Medical Device assay to evaluate the skin sensitizing potential of medical device materials using both polar and non-polar extraction vehicles (ISO 10993-12).
- A case study using in vitro data for the endpoints of cytotoxicity, skin irritation and skin sensitization in the biological evaluation for CE-marking according to MDR to avoid animal testing while accelerating time to market
- Andy Forreryd - Key Account Manager & Scientific Liason, SenzaGen
- Completion of a gap assessment
- Tips to score with your NB
- State of the art concept
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - IVDMD Department Manager - GMED Certification Division - France, LNE/G-MED
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
- Latest modules released
- Complying with EUDAMED
- Deadlines
- Bottleneck
- Practical solutions
- Roadmap for EUDAMED
- Richard Houlihan - CEO, EirMed
The introduction of new UDI requirements in the EU MDR/IVDR regulations has fueled an increased focus by regulatory affairs teams. However, Europe is not the only region that is adding UDI requirements for medical technology products. Countries around the world from Saudi Arabia to Singapore have implemented some aspects of UDI, and many more will come online in the coming years. While UDI and other product labeling information have typically been maintained separately from other regulatory information, the growing complexity of supporting multiple markets is introducing compliance challenges. Companies can no longer treat it simply as an operational or supply chain process.
EUDAMED delays have given companies a slight reprieve, but the time to get a handle on UDI data is rapidly running out. This session will explore UDI requirements across several major markets, including the types of devices that are covered and the expected implementation timelines. We’ll discuss best practices for managing UDI information – including new Basic UDI-DI fields – by centralizing it alongside product registrations, certificates, manufacturing site licenses, and other critical regulatory information.
Attendees will learn:
- How products will be impacted by MDR/IVDR as well as other global UDI requirements
- Data requirements and issuing entities for different regions
- How to curate “universal” UDI data for reuse across country-specific submissions
- James Gianoutsos - CEO, Rimsys
- MDR requirements on UDI system
- Timeline to keep in mind
- Actors involved and relevant requirements: a visual summary
- Where information on UDI is available
- Carla Cambiano - Biomedical Engineer, Italian Ministry of Health - Directorate General of Medical Devices and Pharmaceutical Service
- Crystal D’Silva - Manager, Pre-Clinical Toxicology – Global Quality, Baxter
- Aligning rigor of evaluation with overall risk.
- Case studies highlighting strategies and challenges.
- Considerations for internally vs. externally imposed changes; addressing patient safety vs. regulatory risk
- David Einum - Principal Biocompatibility Scientist, W.L. Gore & Associates
- Jaishankar Kutty - Vice President, Intelligence and Innovation, RQM+
- Changes to chemical characterisation standards
- Regulatory Perspective - TC 194 member run through of upcoming updates
- How will these affect the biocomp testing process, implementing changes
- Gina Quiram - Regulatory Affairs Compliance Manager (Biocompatibility and Safety & Performance Standards), Koninklijke Philips N.V.
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - IVDMD Department Manager - GMED Certification Division - France, LNE/G-MED
How to demonstrate Performance Evaluation and Clinical Evidence
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - IVDMD Department Manager - GMED Certification Division - France, LNE/G-MED
- Demi Dabor-Alloh - Manager, MedTech & Life Sciences, EY
- Status update on global UDI implementation
- EUDAMED and GUDID
- Adopting a global labelling system to streamline approaches
- Key challenges with implementation
- How is industry handling data?
- Addressing bottlenecks for manufacturers
- Giacomo Cargnello - Head of Quality & Regulatory, Connect&Control Solutions, Varex Imaging
- The current MDR deadlines
- What are the new deadlines for each device type?
- Does everyone qualify for the extensions?
- Impact on the medical device hierarchy
- Do industry really have more time for MDR submissions with these extensions?
- How does this affect Regulatory Authority and Notified Body capacity?
- Best practices from all stakeholders to meet the new deadlines
- Perceived effect on medical device market in light of the new deadlines
- Will enough devices be certified to cope with market demand by 2027/2028?
- Alex Charitou - Partner, MedTech Lead, EY
- Cécile van der Heijden - Attorney at Law, Axon Lawyers
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
- Frank Matzek - Vice President Regulatory & Governmental Affairs, BIOTRONIK
- Juliette Cook - Vice President Regulatory Affairs & Quality, Implantica
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
- Nadège Krebs, PhD - Customer Consultant Embase, Elsevier
- Navigating the evolution of the ISO 10993-1 based on available drafts.
- How will Notified Bodies be incorporating the changes to ISO 10993 part 1 into the review process?
- Will these updates have a large effect on Manufacturers?
- Aspects to consider when implementing changes to accommodate these updates
- Christina Reufsteck - Biocompatibility Expert, TÜV SÜD Product Service GmbH
- Crystal D’Silva - Manager, Pre-Clinical Toxicology – Global Quality, Baxter
- Marco Costante - Group Leader – Human Health, Environmental & Human Toxicology, knoell Germany GmbH
- Paolo Pescio - Senior Scientific Director, Medical Devices, Eurofins Medical Device Testing Europe
IVDR requirements & NB expectations
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - IVDMD Department Manager - GMED Certification Division - France, LNE/G-MED