FINAL SAVINGS EXPIRE IN:
- 00Days
- 00Hrs
- 00Mins
- 00Secs
10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)MedTech Summitabout eventkeyboard_arrow_right
European Medical Device Regulations
Medical Device Law and Compliance
In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation
11:40 - 12:10
DUAL DIALOGUE Advantages and Challenges of UK Innovative Device Alternative Pathway (IDAP)
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?
Speaking Opportunities Available
Please contact: Roshni Shah – roshni.shah@informa.com
Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
Alex Denoon - Partner, Bristows LLP
12:10 - 12:40
Moving Towards a Global View: Technical Regulatory Approach to Support Design Projects and Market Authorisations
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
Kenneth Usher - Technical Regulatory Compliance Manager, Intersurgical
14:15 - 14:45
A Guide to Material Compliance: How to Successfully Navigate GSPR 10.4 CMR/ED Substances
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
14:45 - 15:15
Spotlight Session: Navigating European Medical Device Regulations
Spotlight Session: Navigating European Medical Device Regulations
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
14:10 - 14:15
Chairperson’s Afternoon Remarks: Medical Device Law and Compliance
Chairperson’s Afternoon Remarks: Medical Device Law and Compliance
Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
10:10 - 10:40
Medical Devices and the Swiss Market in 2024
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
14:15 - 15:15
DUAL DIALOGUE IVDR Developments for Companion Diagnostics: From Clinical Trials and Regulatory Approval to Reimbursement
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
08:30 - 08:40
Chairperson’s Opening Remarks: European Medical Device Regulations
Chairperson’s Opening Remarks: European Medical Device Regulations
08:40 - 09:40
EU MDR: Timelines, Transitions and Tribulations
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 approval in Europe?
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
Paul Piscoi - Scientific Policy Officer, European Commission
14:10 - 14:15
Chairperson’s Afternoon Remarks: European Medical Device Regulations
Chairperson’s Afternoon Remarks: European Medical Device Regulations
11:10 - 11:40
Spotlight Session: Navigating European Medical Device Regulations
Spotlight Session: Navigating European Medical Device Regulations
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
11:10 - 12:40
Directive to Regulation Data
Directive to Regulation Data
- Completion of a gap assessment
- Tips to score with your NB
- State of the art concept
11:40 - 12:10
The Forgotten Devices: Regulating Orphan Devices
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
09:10 - 10:40
The Pre-Application Phase
The Pre-Application Phase
- Structure of a Technical Documentation file
- Notified Body code assignment
- Classification
- Creation of sampling groups
11:10 - 11:40
DUAL DIALOGUE Where to Launch? Comparison of EU CE Mark with UK CA and the Swiss CE Label
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
16:15 - 17:45
Clinical Evidence (continued) and Post Market Surveillance
Clinical Evidence (continued) and Post Market Surveillance
- IVDR requirements & NB expectations
15:15 - 15:45
DUAL DIALOGUE Legal Recourse: What to Do When your Competitor Breaks the Rules
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
14:15 - 15:45
Performance Evaluation and Clinical Evidence
Performance Evaluation and Clinical Evidence
- How to demonstrate Performance Evaluation and Clinical Evidence
09:10 - 09:40
DUAL DIALOGUE What does the Artificial Intelligence (AI) Act Mean for Medical Devices and IVDs
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
16:45 - 17:45
DUAL DIALOGUE Legal Advice and Avoiding Common Trip Points for Medical Device Commercial Transactions
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
Anaïs Chazal - Legal Counsel, EMEA, Zimmer Biomet
14:10 - 14:15
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Workshop
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Workshop
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 - Certification Division Manager In Vitro Diagnostics Medical Devices, GMED
16:15 - 16:45
Preparing for the European Product Liability Directive
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
16:45 - 17:45
Multi-Stakeholder Perspective: The Impact of the MDR on Innovation & Industry
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
09:40 - 10:10
DUAL DIALOGUE Navigating Data Frameworks and European Health Data Space (EHDS)
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
09:00 - 09:10
Chairperson’s Opening Remarks: Medical Device Law and Compliance
Chairperson’s Opening Remarks: Medical Device Law and Compliance
Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
10:10 - 10:40
DUAL DIALOGUE Decoding the Impact of Enhanced Cyber Security Regulations for Medical Devices and IVDs
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
12:10 - 12:40
DUAL DIALOGUE The Liability Risks and Implications of Regulatory Failings
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
15:15 - 15:45
Economic Operators and Supply Chains: Ensuring Compliance Throughout
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
16:15 - 16:45
Curating a New Perspective: From ‘Sick Care’ to ‘Health Care’
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)
09:00 - 09:10
Chairperson’s Opening Remarks: In Vitro Diagnostic Workshop
Chairperson’s Opening Remarks: In Vitro Diagnostic Workshop
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 - Certification Division Manager In Vitro Diagnostics Medical Devices, GMED
09:40 - 10:10
UKCA State of Play
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
MedTech Summit - European Medical Device Regulations
08:30 - 08:40
Chairperson’s Opening Remarks: European Medical Device Regulations
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 approval in Europe?
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
Paul Piscoi - Scientific Policy Officer, 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
11:10 - 11:40
Spotlight Session: Navigating European Medical Device Regulations
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
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
Kenneth Usher - Technical Regulatory Compliance Manager, Intersurgical
14:10 - 14:15
Chairperson’s Afternoon Remarks: European Medical Device Regulations
14:15 - 14:45
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
14:45 - 15:15
Spotlight Session: Navigating European Medical Device Regulations
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
15:15 - 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
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
MedTech Summit - Medical Device Law and Compliance
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
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?
Speaking Opportunities Available
Please contact: Roshni Shah – roshni.shah@informa.com
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
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
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
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
Anaïs Chazal - Legal Counsel, EMEA, Zimmer Biomet
MedTech Summit - In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation
09:00 - 09:10
Chairperson’s Opening Remarks: In Vitro Diagnostic Workshop
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 - 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
11:10 - 12:40
Directive to Regulation Data
- Completion of a gap assessment
- Tips to score with your NB
- State of the art concept
14:10 - 14:15
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Workshop
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 - 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
16:15 - 17:45
Clinical Evidence (continued) and Post Market Surveillance
- IVDR requirements & NB expectations