Extract from Lords consideration of the Medical Devices (Northern Ireland Protocol) Regulations 2021 - July 12
Tuesday, 13 July 2021 08:39
Baroness Thornton (Lab):...What does this mean for people in
Northern Ireland? What impact will there be if the EMA and MHRA
depart markedly from each other’s regulatory regimes, and what
would that mean for businesses? At the moment, you need a CE mark
to go to market, as least as long as the Northern Ireland protocol
holds. That is potentially advantageous for NI patients versus GB
ones, as the vast majority of products will be CE marked and will
continue to be so. However, as the ABPI...Request free trial
(Lab):...What does this mean for people in Northern Ireland? What
impact will there be if the EMA and MHRA depart markedly from each
other’s regulatory regimes, and what would that mean for
businesses? At the moment, you need a CE mark to go to market, as
least as long as the Northern Ireland protocol holds. That is
potentially advantageous for NI patients versus GB ones, as the
vast majority of products will be CE marked and will continue to be
so. However, as the ABPI has said, there are 600,000
medical devices approved in the EU and, at the moment, they are all
available in Great Britain. Surely the test of the new UK
regulations will be how many of them are still available in three,
five or 10 years’ time. I hope that the Minister will be able to
address those issues...
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