FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

MedTech Europe Highlights Flaws, Needed Solutions for Brexit Plan

Nov. 17, 2017

MedTech Europe is very concerned about the implications of a divergence in the regulatory framework for medical devices and in vitro diagnostics arising from Brexit.

The devicemaker group released a position paper suggesting possible ways to mitigate risks during the negotiation period between the UK and the European Union. The paper lists three challenges that could affect the supply of medical devices in both markets:

  • Just-in-time delivery of parts or finished products could be hampered by a new customs regime;
  • Refurbishment and repair services that would need to cross borders face significant cost and time hurdles; and
  • Devices and IVDs could be subject to tariffs that would increase their manufacturing costs.

As the EU implements its new medical device and IVD regulations, the association is urging the UK to remain aligned with the EU27 regulatory system, saying that any divergence of regulatory systems, even in secondary legislation, would impact manufacturers and suppliers by adding costs and complexities in bringing products to market.

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