EU & UK Medical Device Legislation Guidelines

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  • #40777

    Hi,

    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?

     

    Thanks

    #40778

    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:

    https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

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