By Ronald Boumans, Emergo Group
The United Kingdom (U.K.) may leave the European Union (E.U.) on 29 March 2019. The draft agreement on Brexit has not yet been ratified by the U.K. and the E.U. parliaments. The Netherlands and the E.U. are therefore still preparing for various scenarios. One of those scenarios is that no agreement is reached (a ‘no deal’ scenario). In case of a no deal Brexit, existing legislation concerning medical devices and in-vitro diagnostics will no longer be applicable to the U.K. as of the withdrawal date at which the U.K. leaves the E.U.. The E.U. legislation does not change, but companies that are based in the U.K. or that distribute their devices via the U.K. to the E.U. must adapt to the new situation in which the U.K. will become a third, non-E.U. country.
Get the full story here at the Emergo Group’s blog.
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