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<p>The Medicines and Healthcare products Regulatory Agency (MHRA) are unable to intervene
in issues relating to capacity in the EU system. However, the MHRA recognises that
there is a need to increase Approved Body capacity to ensure the continued supply
of imported medical devices and equipment to the UK market by reducing regulatory
barriers for companies and healthcare providers importing said devices. The MHRA are
engaging with, reviewing applications from and auditing a number of organisations
who have applied to be designated as a UK Approved Body. The MHRA is taking a pragmatic
approach to the designation of these Approved Bodies, balancing the need to establish
an independent UK system against avoiding any unnecessary duplication</p><p>On the
25<sup>th</sup> October 2022, the MHRA announced that there will be a 12-month extension
to the implementation of new UK Medical Device Regulations to accommodate for any
disruption caused by the Great Britain’s departure from the European Union. Manufacturers
will be able to continue to place CE marked devices on the Great Britain market after
1 July 2023. Following this, from July 2024 the transitional arrangements will apply
for CE and UKCA marked devices placed on the Great Britain market. Manufacturers are
also able to apply to the MHRA for an Exceptional Use Authorisation (EUA) which permits
the supply of a medical device without a valid CE or UKCA mark in certain circumstances.</p><p>In
addition to building Approved Body capacity and extending the implementation of the
revised UK regulations, the MHRA is working, with industry partners and designated
Approved Bodies, to assess what further actions can be taken to ensure ongoing supply
of medical devices where manufacturers have been unable to secure ongoing certification.</p>
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