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Selling Medical Devices: Embracing the Challenges and Opportunities of Regulatory and Legal Change

  • Citylabs 1.0 Nelson Street Manchester, England, M13 9WP United Kingdom (map)
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Fieldfisher's life sciences sector group is pleased to share their solutions to the issues raised by the many recent changes to the laws, regulations and practices which affect the sale of medical devices. This highly practical one day workshop will provide you with tips for adapting to and embracing these challenges, as they share their learnings on a range of topics.

Agenda

10:45 Registration and Networking

11:00am Brexit Perspectives:  Where are with MDR/ IVDR and Brexit?

11:10am MDR/IVDR: A new dawn, and not just for the regulatory team

  • Introduction
  • New labelling and advertising requirements
  • Consistency of application:  Regime change
  • Distance sales
  • Importers and distributors as economic operators: 
  • Understanding and taking advantage of the transitional period

12:10pm Competition Law:  In medical device supply arrangements

  • Bundling
  • Rights vs the NHS in their pricing models (and that of the delegated authority)
  • What are Supply Chain's obligations to manufacturers

12:30pm Digital devices:  Wellness apps vs medical devices:

  • Where to draw the line

1:00pm Lunch and networking

2.00pm Procurement and the NHS

  •  Engaging with innovative partnerships
  • Procurement challenges

2:30pm Notified Bodies:  The challenges they face and how to challenge them

2.50pm All change in Product Liability

3.30pm

Break

3:45pm Transparency - Brief Introduction to European Rules: 

  • Transparency requirements and anti-gift laws in a selection of European Countries.

4:15pm Selling Medical Devices in Europe 2:  Advertising

  • Taking care with social media use and tips for compliant consumer advertising

5:00pm OBN Networking Event