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The end of the Brexit Transition Period – Impact on Medical Device Industry Training Course

90 minute live webinar
13:00 (UK/London Time Zone)

25 Jan 2021

Book now

Details

The end of the transition period - are you prepared for the changes?

The UK has left the EU, and the transition period has now ended. This will have major implications for all aspects of Medical Device Regulations in the UK.

During this 90 minute webinar, our expert speakers Dr David Jefferys and Philip Brown will discuss the key issues, including:

  • The new UK Medical Device Controls 
  • How the UK will control medical devices 
  • How the UK will take forward the delayed EU Medical Device Regulation 
  • What happens to existing CE marked products 
  • UK Conformity Bodies 
  • Device Trials in the UK 
  • Post Marketing Surveillance and Vigilance 
  • Role of the MHRA 
  • IVD issues and companion diagnostics 

This webinar will include a 45 minute presentation, followed by a discussion and Q&A session.


Programme

The end of the Brexit Transition Period – Impact on Medical Device Industry

  • Introduction
  • How the UK will control medical devices
  • The implications of the Northern Ireland Protocol
  • How the UK will take forward the delayed EU Medical Device Regulation
  • What happens to existing CE marked products
  • MMDI Bill
  • UK Conformity Bodies
  • Device Trials in the UK
  • Post Marketing Surveillance and Vigilance
  • Role of the MHRA in future – including the international agenda
  • IVD issues and companion diagnostics -
  • Combination products
  • Q&A and discussion session
  • Concluding remarks

Presenters

Phil Brown (More...)

Phil started his career at Smith and Nephew qualifying as a Graduate of the Royal Society of Chemistry in 1984, before joining the Company’s Woundcare Regulatory Affairs team at the time when the Medical Device Directive was being enacted. Company moves to Genzyme Biosurgery, Quintiles, Wright Medical Technology and more latterly Kinetic Concepts Inc., (an Acelity company), included work with novel technologies, liaising with National Authorities, the European Commission, Trade Associations and standards bodies on issues related to regulation and ethics.

Phil extended his Trade Association work by joining the ABHI in June 2016 as the Director responsible for regulatory and compliance matters. Phil is a Fellow of TOPRA and lectures at the Sheffield Hallam University on medical device regulatory frameworks. He also chairs the UK BSI’s CH/210 working group which has a mirror relationship to the ISO committee responsible for quality and risk standards.

David Jefferys (More...)

Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices.

He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.

Book now

Book now

25 Jan 2021
Live webinar
25 Jan 2021
Live webinar
GBP 99.00
EUR 139.00
USD 154.00
+ VAT @ 20.00%
Enrol now
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This course qualifies for 6 hours for your CPD records.
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Previous customers include...

  • ConMed
  • SGR Consulting Services Ltd