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I had a question regarding the this paragraph-
As the MDR and IVDR do not come into effect
until after the end of the Brexit transition period,
31 December 2020, they will not be effective in
Great Britain (England, Scotland and Wales). The
current devices vigilance legislation therefore
continues to be effective though the Medicines
and Medical Devices Bill10.
From the above I believe it means that Great Britain (England, Scotland and Wales) will not follow the new MDR and keep on following MEDDEV 2.12-1 rev. 8 Guidelines on a medical devices vigilance system. Republic of Ireland and Northern Ireland will follow the new MDR?
Hi yes that is correct – the MDR and IVDR will not apply to GB – only NI and the Republic of Ireland/Europe. However, you still have to register all your IVDs and MDDs that you intend to sell on the GB market with the MHRA according to their timelines – the first of which is tomorrow (1st May) for List A IVDs and Class 3 MDDs. There is some useful guidance here:
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