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08:00 09:00 (60 mins)

Main agenda

Registration

09:00 09:10 (10 mins)

EU Medical Device Regulation

Opening remarks from the chairperson

  • Mika Reinikainen - Managing Director, Abnovo Ltd., UK

09:00 09:10 (10 mins)

Clinical Evaluations and Investigations for Medical Devices

Opening remarks from the chairperson

  • Henry Sibun - Director, Henry Sibun Associates Ltd, and External Notified Body Reviewer/Lead Auditor for at TÜV SÜD Product Service GmbH, UK

09:00 09:10 (10 mins)

Post Market Surveillance and Vigilance

Opening remarks from the chairperson

  • Philippe Auclair - Senior Director, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory, Abbott, Belgium

09:10 09:45 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Discussing the impact of the new EU Medical Device Regulation (MDR) on clinical evaluations and investigations

  • Outlining the key ways in which the new MDR will impact clinical evaluations and investigations
  • Exploring what industry should be doing to prepare
  • Reviewing Competent Authority and Notified Body expectations for clinical evaluations and investigations
  • Overcoming key pitfalls and challenges
  • Emmanuel Prades - Director of Clinical Operations, Voisin Consulting Life Sciences, France

09:10 09:45 (35 mins)

Post Market Surveillance and Vigilance

Clarifying the changes in the new MDR relating to post market surveillance (PMS) and vigilance

  • Examining the key areas of the MDR that will impact PMS and vigilance
  • Determining how changes to PMS and vigilance requirements will impact industry
  • Exploring the current status of the UDI rule in Europe and how this impacts PMS and vigilance
  • Overcoming key PMS and vigilance challenges
  • Kristine Rasmussen - Senior Regulatory Affairs Professional, Ambu A/S, Denmark

09:10 09:45 (35 mins)

EU Medical Device Regulation

Latest updates on the reprocessing of single-use devices and implications for industry

  • Understanding why reprocessing of single-use devices was such a hotly debated issue and latest updates on what the final provision looks like in the MDR
  • Exploring how industry handle reprocessing and key challenges and concerns
  • Determining what needs to be tested and how testing should be carried out on devices
  • Examining the Competent Authority expectations for reprocessing
  • Dan Vukelich - President, Association of Medical Device Reprocessors (AMDR), USA

09:45 10:20 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Clinical investigation applications under the new MDR - the Belgian competent authority perspective

  • Examining clinical investigation applications under the new MDR
  • What is the Belgian competent authority perspective?
  • Pieter Van de Vijver - Non-Clinical Assessor, Medical Devices, FAMHP, Belgium

09:45 10:20 (35 mins)

Post Market Surveillance and Vigilance

A guide to PMS: what to pack and where to go - an industry perspective

  • Exploring a guide to PMS
  • Reviewing what to pack and where to go
  • Ruben Roijers - Post Market Surveillance, Philips, The Netherlands
  • Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands

09:45 10:20 (35 mins)

EU Medical Device Regulation

Reprocessing, the new approach

  • Reprocessing in the MDR
  • National implementation of reprocessing
  • European positions
  • Arjan van Drongelen - Scientific Officer, National Institute for Public Health and the Environment (RIVM), The Netherlands

10:20 10:55 (35 mins)

EU Medical Device Regulation

Delivering ‘Connected Health’ across devices and software applications under the new regulatory framework

Case study: Clinical decision support (CDS) software used by endocrinologists with their patients that have Type II diabetes

  • Comparing/contrasting EU and US regulatory framework
  • How is the software regulated in the US with the introduction of 21st Century Cures Act?
  • How might 21 CFR 868.9 impact the regulatory decision?
  • How is the software regulated in the EU with the introduction of Medical Device Regulation?
  • How might MEDDEV 2.1/6 be used?
  • Scott Thiel - Director, Navigant, USA

10:20 10:55 (35 mins)

Post Market Surveillance and Vigilance

Operationalizing post market surveillance for a global company

  • Determining how to optimise post market surveillance for a global company
  • Key challenges faced
  • Patrick Caines - Senior Director, Quality & Compliance, Baxter, USA

10:20 10:55 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Notified Body perspective: MEDDEV 2.7.1 Revision 4 key changes and clarifications for clinical evaluations

  • Exploring an overview of the MEDDEV guidance document 2.7.1 Revision 4 and key implications for industry
  • Outlining the key changes impacting Notified Bodies in the new guidance
  • Best practice for performing gap assessments and reviewing the need for additional resources
  • Discussing whether compliance with the new MEDDEV guidance means compliance with the MDR
  • Reviewing what might still not be fulfilled in the MDR, when complying to the new MEDDEV guidance
  • Itoro Udofia, UL, UK

10:55 11:25 (30 mins)

Main agenda

Networking and Morning Coffee

11:25 12:00 (35 mins)

Post Market Surveillance and Vigilance

Case study: Ensuring best practice for Field Safety Corrective Action (FSCA) reporting

  • Outlining how the new MDR impacts FSCA reporting and implications for industry
  • Understanding and meeting Competent Authority requirements for FSCA reporting
  • Clarifying what Competent Authorities require when initiating a recall
  • Exploring best strategies for getting FSCA responses from subsidiaries
  • Maite Llácer - Director Quality Compliance EMEAC, Edwards Lifesciences, Spain

11:25 12:00 (35 mins)

EU Medical Device Regulation

Challenges of medical devices containing substances which are carcinogenic, mutagenic or toxic to reproduction (CMR) of category 1A or 1B and /or endocrine disrupting substances

  • What is the scope and what are CMR 1A 1B & endocrine disrupting substances?
  • What is the latest status?
  • Certain substances will require justification, what are the challenges?
  • How will the labelling of medical devices be impacted?
  • Nigel Talboys - Director, Global Government Affairs and Public Policy, Terumo BCT, Belgium

11:25 12:00 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Industry case study: Practically applying the new MEDDEV 2.7.1 Revision 4 guidance for clinical evaluations

  • Exploring how the MEDDEV 2.7.1 Revision 4 has been interpreted and applied to daily work
  • Discussing new requirements and how these have been addressed
  • Sharing experiences with implementing gap assessments
  • Overcoming key challenges and pitfalls when applying the new MEDDEV guidance
  • David Rutledge - Head of Global Clinical Evaluation Department, Abbott Vascular, USA

12:00 12:45 (45 mins)

EU Medical Device Regulation

MDR: Navigating from here to there – publication to implementation

With the council text confirmed the countdown to implementation has begun. Companies need to navigate quickly through uncertainty in order to ensure they can remain compliant and keep their products in the Market. With deep experience of large scale MDR implementation projects, and extensive work with companies tackling the MDR challenge so far, EY is providing guidance on some of the implementation pitfalls and challenges together with tips on how to address them.

  • Jon Lange - Principal – Life Sciences Advisory, EY, USA

12:00 12:35 (35 mins)

Post Market Surveillance and Vigilance

A practical approach to PMS: from hassle to efficiency

  • A reminder of why regulations ask for a PMS
  • Easy PMS Management for small & medium businesses
  • Business benefits of an efficient PMS
  • Julie Coste - Associate Director, Nexialist SARL, France

12:00 12:35 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

MedDev 2.7/1 rev 4: A Hands-on Guide on How to Write a Clinical Evaluation Report

  • New pitfalls - new opportunities
  • How to evaluate benefit/risk
  • Demonstration of conformity with Essential Requirements: are clinical data always necessary?
  • State-of-the-art: how to prevent an excessive documentation
  • Ivo Machatschke - Team Leader, Clinical Evaluations/Research & Development, MED-EL, Austria

12:35 14:00 (85 mins)

Main agenda

Networking Lunch

14:00 14:35 (35 mins)

Post Market Surveillance and Vigilance

Please feel free to move to one of the parallel streams

14:00 14:35 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Generating the necessary evidence through Life Cycle Communication strategy

  • Patrice Becker - Global Director Scientific Communications, Medical Affairs, Medtronic, France

14:00 14:35 (35 mins)

EU Medical Device Regulation

The US and EU UDI requirements – similarities, differences and implementation issues

  • The first significant changes to the medical device regulations in the European Union (EU) in over 25 years are set to finalize this year. Among the many changes is the introduction of a UDI System for all medical devices
  • The EU UDI System specifically (and prospectively) incorporates UDI into various new company and product registration systems and processes. The new regulations also impose obligations for the verification and use of UDI by importers, distributors, authorized representatives and, for certain device types, healthcare providers. The EU UDI System, though similar to the US UDI System, has some significant differences
  • At the same time, there are new “commercial” UDI-like requirements, such as those from the UK National Health System (NHS), that are beginning to develop – which include UDI label, data attributes through GDSN and electronic order and invoice requirements
  • A number of other countries, such as South Korea, India, Saudi Arabia and Taiwan, are likely to publish their own UDI (or UDI-like) requirements over the next 2-5 years
  • Jay Crowley - Vice President, Unique Device Identification Solutions and Services, USDM Life Sciences

14:35 15:10 (35 mins)

EU Medical Device Regulation

Unique Device Identification (UDI): Latest status and requirements

  • Exploring the latest status of UDI system implementation in Europe, the US and other global countries
  • Understanding GS1 and HIBC standards and where they are applied
  • Reviewing how companies are practically implementing UDI systems
  • Determining how hospitals are benefiting from UDI implementation
  • Understanding the resources needed to set up UDI systems and how resource heavy this is
  • Jenny Gough - Process Development Manager/GS1 & UDI Specialist Operations – Value Chain Development and Efficiency, Molnlycke Health Care, UK

14:35 15:10 (35 mins)

Post Market Surveillance and Vigilance

Successfully implementing a robust complaints handling system

  • Best approaches for data collection, analysis and investigation
  • Ensuring that the Regulatory Affairs team get complaints reported to them in a timely manner
  • Collaborating effectively with sales and services teams
  • Exploring software available to streamline the complaints handling process
  • Diane Bouwmeester - Compliance Manager, AQTIS Medical, a Sinclair company, The Netherlands

14:35 15:10 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Case study: Successfully outsourcing clinical investigations

  • Establishing what needs to be outsourced: Full service vs. specific activities
  • Understanding how to choose the right CRO with the most relevant experience for your investigation
  • Best strategies for assuring quality when outsourcing and what kind of oversight is needed
  • Examining advantages and disadvantages of outsourcing
  • Ruud Nonnekens - Clinical Programme and Field Operations, Volcano Corp, The Netherlands

15:10 15:45 (35 mins)

EU Medical Device Regulation

Analysing UDI data using the GMDN: How data collected by the FDA is helping to support the introduction of the new European MD Regulation

  • GMDN introduction
  • US FDA GUDID data analysis using GMDN
  • Practical applications of data
  • Implications for European UDI implementation
  • Edward Glenn - Nomenclature Developer, GMDN Agency, UK

15:10 15:45 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Best practices for CER development: An agency perspective

  • Practical differences in MedDev 2.7.1 and CFDA guidelines for CER development
  • Agency perspective on CER development: Challenges and Solutions
  • Case study
  • Namita Bose - Associate Scientific Director, Cactus Communications, India

15:10 15:45 (35 mins)

Post Market Surveillance and Vigilance

Please feel free to move to one of the parallel streams

15:45 16:15 (30 mins)

Main agenda

Networking and Afternoon Tea

16:15 16:50 (35 mins)

EU Medical Device Regulation

Exploring the responsibilities and obligations of economic operators

  • Outlining how the obligations of economic operators are defined in the new MDR
  • Understanding the need for new contracts and where these need to be issued
  • Examining any new risks for manufacturers that come with new obligations of economic operators
  • Reviewing where economic operators will have liability for defective products
  • Matthias Bürger - Vice President QA/RA EMEA, Zimmer Biomet, Switzerland

16:15 16:50 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Post Market Clinical Follow-Up (PMCF): Exploring Competent Authority and Notified Body expectations

  • Reviewing increased requirements and expectations for PMCF in the new MDR
  • Discussing how increased PMCF requirements will impact industry
  • Outlining how PMCF activities may vary depending on different product types
  • Examining how often and to what extent PMCF should be carried out
  • Bassil Akra - Vice President - Global Focus Teams (Cardiovascular, Orthopedic and Clinical), TÜV SÜD Product Service GmbH, Germany

16:15 16:50 (35 mins)

Post Market Surveillance and Vigilance

Post Market Clinical Follow-Up (PMCF): Exploring Competent Authority and Notified Body expectations

  • Reviewing increased requirements and expectations for PMCF in the new MDR
  • Discussing how increased PMCF requirements will impact industry
  • Outlining how PMCF activities may vary depending on different product types
  • Examining how often and to what extent PMCF should be carried out
  • Bassil Akra - Vice President - Global Focus Teams (Cardiovascular, Orthopedic and Clinical), TÜV SÜD Product Service GmbH, Germany

16:50 17:25 (35 mins)

EU Medical Device Regulation

Clarifying risk management requirements for medical devices under the new MDR

  • Exploring the MDR requirements for establishing risk management systems and how to practically implement this
  • Determining risk management requirements in the MDR that are not specified in ISO 14971
  • Ensuring risk management documentation is updated for compliance with the MDR and ISO 14971
  • Overcoming key challenges and pitfalls for risk management
  • Bart Mersseman - Head of Notified Body Medical Devices, SGS Belgium N° 1639, Belgium

16:50 17:25 (35 mins)

Clinical Evaluations and Investigations for Medical Devices

Industry case study: Practically implementing Post Market Clinical Follow-Up (PMCF) activities under the new MDR

  • Examining how increased requirements for PMCF have impacted daily work
  • Discussing the importance of being proactive with PMCF
  • Clarifying the importance of continually analysing PMCF data
  • Overcoming key challenges experienced with implementing PMCF
  • Gudrun Denke - Head of Clinical Science Support, Geistlich Pharma AG, Switzerland

16:50 17:25 (35 mins)

Post Market Surveillance and Vigilance

Industry case study: Practically implementing Post Market Clinical Follow-Up (PMCF) activities under the new MDR

  • Examining how increased requirements for PMCF have impacted daily work
  • Discussing the importance of being proactive with PMCF
  • Clarifying the importance of continually analysing PMCF data
  • Overcoming key challenges experienced with implementing PMCF
  • Gudrun Denke - Head of Clinical Science Support, Geistlich Pharma AG, Switzerland

17:25 18:00 (35 mins)

EU Medical Device Regulation

Exploring latest updates on the MDSAP program and how this will impact industry

  • Understanding what MDSAP involves and who the key stakeholders are
  • Reviewing how MDSAP can impact auditing time and market access
  • Benefits for manufacturers participating in MDSAP
  • Exploring the findings from the MDSAP pilot. How Canada, the US, Australia, Brazil and Japan recognize MDSAP audit reports and certificates
  • Clarifying how MDSAP differs from previous programs and implications for industry
  • Georg Bauer - Department Manager, Foreign Affairs, TÜV SÜD Product Service GmbH, Germany

18:00 18:05 (5 mins)

EU Medical Device Regulation

End of EU MDR Conference Day Two

17:25 17:30 (5 mins)

Main agenda

End of Conference Day Two