FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Brexit Health Alliance: A ‘No Deal’ Could Impact Medical Device Supply Chains

Feb. 6, 2018

The Brexit Health Alliance is calling for post-Brexit cooperation between the European Union and the United Kingdom on medical device regulations to avoid disruption of international supply chains.

Brexit “could have serious implications for patients’ access to medicines and medical technologies,” according the alliance, whose members include the Academy of Medical Royal Colleges, the Association of British Healthcare Industries, and the NHS Confederation, among several other stakeholders.

The call comes as the U.K. and the EU negotiate over continuing relations post-Brexit. Regardless of whether they reach a “deal” or “no deal” on continuing relations, a lack of EU-U.K. cooperation on medical devices “could put public health at risk,” the alliance said.

BHA pointed to one reason a “no deal” could have a detrimental impact on supply chains — an estimated 50 percent of the assessment work for authorizing products to reach the EU market is done in the U.K. “There is already limited capacity in this area across Europe and any possible loss of capacity could clearly impact the availability of medical devices,” the alliance said.

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