UK Fieldfisher Law Experts Detail Implications of Brexit for Irvine/US Medical Device Manufacturers and Distributors

Tuesday, March 19, 2019

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Deal. No deal. EU extension or second referendum. The one word everyone agrees upon when describing Brexit and its implications for the U.K. and every company that does business in the country is: uncertainty. Although the March 29 deadline is looming, negotiations with the EU for a delay and Parliament debate continues.

Fieldfisher, the European law firm specializing in lifesciences and technology law visited the Greater Irvine Chamber on March 19. Alison Dennis, Partner with the London Office, met with the Chamber and its foreign direct investment delegation in 2017, just months after the Brexit vote. Knowing that Irvine has a robust medical device and technology sector, Fieldfisher chose the Greater Irvine Chamber to present their current take on Brexit. Dennis, along with Felicity Fisher, director with the Fieldfisher Silicon Valley Office, presented timelines, advisories, regulation changes, and legal implications for the above scenarios to Chamber members and businesses most likely impacted by Brexit.

The dominant takeaway: companies that do business in the U.K. should take action now and prepare for all of these scenarios, making certain to have U.K. and EU notified bodies engaged, authorized representation, and legal manufacturers in both geographic footprints. It’s likely that all medical devices will require additional clinical evaluations and requirements for sale will be increased. Some of the changes likely to occur regardless of the Brexit resolution include:

  • Classification
  • Routes to conformity
  • Necessity for clinical evaluation/performance review
  • General medical devices will be subject to anywhere from 13 essential requirements to 23 general safety and performance requirements (GSPR)
  • In vitro diagnostic devices will be subject to anywhere from eight essential requirements to 20 GSPRs
  • Change in risk management system include potential new angles (overall residual risks and risks associated with each hazard)
  • Greater transparency with patients on risks

Additionally, Fisher presented enhanced privacy laws governing the collection, retention, and use of clinical data, patient records, general data collection, and research. She advised companies to consider their processes carefully to maintain compliance.

For more information and to connect with Alison Dennis or Felicity Fisher regarding Brexit and its implications for your business, contact Linda DiMario, executive vice president, Greater Irvine Chamber.

Category: Chamber News, International Trade, Advocacy