Brexit may frustrate access to med tech
The Irish Medtech Association – the Ibec group that represents the medtech sector – has warned that the EU is running out of time to make sure that the necessary infrastructure is in place to ensure that the care continuum for patients is preserved under the new EU Medical Devices and Invitro Diagnostics Regulations.
Irish Medtech Association Senior Executive Dr Áine Fox issued her warning at last week’s Global Access 2018 conference in Galway’s Galmont Hotel.
“While industry has invested heavily in making changes to their businesses and training staff to be adequately equipped to comply with the new EU Medical Devices and IVD Regulations, the regulatory infrastructure is not ready,” she said.
“After more than half a decade of development and negotiation the EU has underestimated what is needed to ensure patients continue to have access to the 500,000 medical technology product groups that are currently on the global market after the regulations come fully into operation by the end of May 2020 for medical devices and May 2022 for invitro diagnostics,” she added.
Dr Fox pointed out that medical devices were used to diagnose, monitor and treat patients – but before they can go onto the market manufacturers must demonstrate that their products meet EU safety, health and environmental protection requirements.
“The Irish Medtech Association and its members provided significant feedback and comment during development of the new regulations to reflect the evolution of this innovative sector which saves and improves lives. But businesses are now being encouraged to develop contingency plans,” she added.
For more, read this week’s Connacht Tribune.
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