Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden
Leader: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden
An overview of the future regulatory framework and the key changes in the new Medical Device Regulation (MDR). What will their impact be on industry and how can organisations best prepare to deliver the new requirements within the timelines?
Chair: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden
The new Medical Device Regulation
Erik Hansson – Deputy Head of Unit, Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, Health Technology and Cosmetics, European Commission
Implementation challenges, how to prepare
Céline Bourguignon – Director Global Regulatory Policy, Johnson and Johnson, Belgium
Panel discussion: “How to work together” moderated by Margareth Jorvid
This session’s speakers and speakers from Session 2 (Notified Body + Competent Authority) will take questions from the floor.
Leader: Gert Bos, Qserve Group BV, the Netherlands
The new MDR changes supervision requirements both for notified bodies (NBs) and competent authorities (CAs). There are changes to setting up as an NB, conformity assessment routes and methods of practice. For CAs there are more specific requirements on supervision of NBs, market surveillance, and formulating and approving delegated and implementing acts, as well as common specifications.
Chair: Sabina Hoekstra – Philips, The Netherlands
In recent years, additional instructions and guidance to notified bodies have been issued, resulting in stricter conformity assessment routes. In addition, the 2016 publication of the MEDDEV 2.7/1 rev.4 guidance on clinical evaluation has further enhanced the expectations to keep products on the market. Key players from CAs and NBs will explore their new level of expectations, and will provide guidance and explanations to the audience.
Impact on Notified Body
Giovanni Di Rienzo - Global director Cardiovascular Focus Team, TÜV SÜD Product Service, UK
Impact on Competent Authority
John Wilkinson – Director of Devices Division, MHRA, UK
Panel discussion moderated by Sabina Hoekstra
This session’s speakers and speakers of Session 1 (Commission + Industry) will take questions from the floor.
Leader: Tim Chesworth, AstraZeneca, UK
The effective use of apps, connected devices and other digital support services has the potential to have a profound and positive impact on patient outcomes. Regulators recognise this and are trying to adapt in a rapidly changing technological environment. Where do regulators and industry need to collaborate further to ensure patients can realise digital health benefits in a timely but safe and controlled manner?
Chair: Tim Chesworth, AstraZeneca, UK
The future and challenges of software regulation
Valerie Field – Head of Devices Software/apps, Devices, MHRA, UK
Industry challenges with medical device software
Kirsten Paulson – Pfizer, US
Releasing software every week in a regulated environment
David Hubanks – Propeller Health, US
Panel discussion moderated by Tim Chesworth – This session’s speakers will take questions from the floor
End of Session 3 – Delegates move to Human Medicines Symposium
Supported by Pharmalex
Following this, you're free to explore London.
18.15 – 19.15
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Programme subject to change.