Priorities for the evolution of medical device regulatory approval systems

Objectives of the CRT Meeting 

This important event will explore possibilities for harmonisation of global medical device regulation, opportunities of priority access for health technology innovation and regulatory aspects of orphan devices. It is a follow-up meeting to a previous event on medical device regulation held in November 2022.

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Programme

Day 1:  17 April 2024  13:00–18:40 CEST

• 12:00-13:00 - Arrival and buffet lunch

• 13:00-13:05 - Welcome from the CRT Chairpersons by Thomas F. Lüscher

• 13:05-13:15 - General introduction to the workshop by Martine Gilard and Stephan Windecker

• 13:15-13:40 - A clinical academic perspective on the EU medical device regulatory system: how should it evolve? by  Alan Fraser

• 13:40-14:00 - European Commission review of the implementation of the medical device regulations - challenges and proposals by Mario Gabrielli Cossellu and Paul Piscoi

• 14:00-17:10 - SESSION 1 – Priority access for health technology innovation (Moderated by: Stephan Windecker and Jana Kurucova)

• 14:00-14:15 - Regulatory approaches to facilitating device innovation by Andrew Farb, FDA (via zoom)

• 14:15-14:30 - Joint approval programme between the USA and Japan for innovative devices by Mitchell Krucoff

• 14:30-14:45 - Panel discussion by Piotr Szymanski, Martine Gilard, Changfu Wu, FDA (via Zoom)

• 14:45-15:00 - Coffee break

• 15:00-15:15 - Patient’s perspective on accelerated approval pathways by Inga Drossart (ESC Patient Forum)

• 15:15-15:30 - Physician/innovator perspective on accelerated approval pathways by Stephan von Bardeleben

• 15:30-15:45 - Industry perspective on the EU medical device regulatory system: how should it evolve? by Andrea Rapagliosi (Edwards)

• 15:45-16:30 - BREAKOUT SESSIONS 1 (Moderated by: Piotr Szymanski and Jennifer Franke)

  • Group 1: What can Europe and FDA learn from each other? - Lead: Mitchell Krucoff, Rapporteur: Mario Grabelli Cosellu
  • Group 2: How to achieve predictable application of standards across EU notified bodies and expert panels - Lead: Radosław Parma, Rapporteur: Marco Metra
  • Group 3: How to achieve transparency of evidence and of regulatory reviews for medical devices in the EU - Lead: Alan Fraser, Rapporteur: Lia Crotti

• 16:30-16:40 - Report from breakout session 1 – 10 mins - Rapporteur: Mario Grabelli Cosellu

• 16:40-16:50 - Report from breakout session 2 – 10 mins - Rapporteur: Marco Metra

• 16:50-17:00 - Report from breakout session 3 – 10 mins - Rapporteur: Lia Crotti

• 17:00-18:25 - SESSION 2 – Global harmonisation of device approval (Moderated by: Thomas F. Lüscher and Eigil Samset)

• 17:00-17:15 - Global convergence of regulatory standards by Bram Zuckerman, FDA (via zoom)

• 17:15-17:30 - Global cardiovascular device market by John Brennan (Medtronic)

• 17:30-17:45 - Global access to medical devices by Leila Abid

• 17:45-18:00 - International standards for medical devices – can they be produced and implemented globally? by Ajay J Kirtane

• 18:00-18:15 - Total lifecycle assessment - new devices, post market surveillance, device iterations and recertification - Giulio Stefanini

• 18:15-18:25 - Wrap-up and summary day 1 – Outlook to day 2 - Chairpersons

• END OF DAY 1

• 19:45 - Dinner

Day 2:  18 April 2024  08:30–12:15 CEST

• 08:30-08:40 - Summary of day 1 by Stephan Windecker
• 08:40-12:10 - SESSION 3 – Orphan devices and unmet medical needs (Moderated by: Martine Gilard, Alphons Vincent)
• 08:45-09:00 - Criteria for orphan device status - current proposals and definitions by Donal O’Connor
• 09:00-09:15 - Do proposed definitions meet the unmet needs of cardiologists and cardiac surgeons? by Patrick Myers
• 09:15-09:30 - Evidence required for regulatory approval of orphan devices by Gearóid McGauran
• 09:30-10:00 - Panel discussion
• 10:00-10:15 - Coffee break
• 10:15-11:15 - BREAKOUT SESSIONS (Moderated by: Alan Fraser and Eigil Samset)
  • Group 1: How to define unmet medical needs for devices - Lead: Piotr Szymanski, Rapporteur: Donal O’Conor
  • Group 2: Provisional/conditional approval vs full approval - Lead: Robert Byrne, Rapporteur: Archano Rao
  • Group 3: How to increase effectiveness of the EU regulatory medical device evaluation system – priorities for further reform - Lead: Franz Weidinger, Rapporteur: Patrick Myers
• 11:15-11:30 - Coffee break
• 11:30-11:40 - Report from breakout session 1 – 10 mins - Rapporteur: Donal O’Conor
• 11:40-11:50 - Report from breakout session 2 – 10 mins - Rapporteur: Archana Rao
• 11:50-12:00 - Report from breakout session 3 – 10 mins - Rapporteur: Patrick Myers
• 12:00-12:10 - Wrap-up, conclusions, next steps for publication - Chairpersons
• END OF DAY 2
• 12:15 - Buffet lunch and departures