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How Are Low-Risk Devices And IVDs Impacted By A No-Deal Brexit – In The UK And EU27?

Executive Summary

Most low-risk medical devices and IVDs do not need notified body involvement in the EU. This means that, in the event of a no-deal Brexit, they are not impacted by UK government rules that focus on notified bodies. But what will change for low-risk devices and IVDs in the UK post-March 29, the UK's scheduled EU exit day?

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