Reply To: EU & UK Medical Device Legislation Guidelines

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#42289
Ruth Clark
Participant

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