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<p>The United Kingdom and its Notified Bodies have been integral to ensuring a safe
and harmonised regulatory environment within the European Union.</p><p>On 19 March
2018, my Rt. hon. Friend the Secretary of State for Exiting the European Union (David
Davis) confirmed that the UK and EU have agreed a fixed implementation period of 21
months, lasting until December 2020. During this time, access to each other’s markets
will continue on current terms, providing certainty for businesses and citizens across
the EU and UK and time to prepare for the future.</p><p>The Prime Minister’s Mansion
House speech of 2 March 2018 set out what we are aiming for. This included the ambition
to agree a comprehensive system of mutual recognition for the trade of goods between
the EU and UK – including medical devices. If agreed, this approach would ensure that,
as now, products only need to undergo one series of approvals, in one country, to
show that they meet the required regulatory standards - including UK based Notified
Bodies being able to carry out assessments on behalf of the EU.</p><p>The outcome
is dependent on negotiations, but both parties have a shared aim to protect the health
of patients across Europe; and to ensure the safe and timely access to medical devices,
even if our precise relationship will - by necessity - change.</p><p>The Government
is undertaking a wide range of analysis looking at the implications of UK withdrawal
from the EU. Our programme of analysis is constantly developing and evolving, and
includes sectoral analysis. The Government is examining all areas of the UK economy
and seeking input from a wide range of stakeholders.</p>
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