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<p>New European Union Regulations for medical devices (MDR) entered into force in
May 2017 and will fully apply from May 2020.</p><p>The new Regulations substantially
strengthen the regulatory framework for medical devices and notified bodies are having
to make significant changes to meet the enhanced requirements. These changes have
the aim of improving the quality, consistency and rigour of notified body assessments,
which was one of the Government’s key aims for the new legislation.</p><p>Ministers
have met with and received letters from industry representatives who have raised concerns
about capacity in the notified body sector across the EU to support the implementation
of the MDR. The Government recognises the importance of having competent notified
bodies across the EU in place in sufficient time to ensure continuity of supply of
products to the United Kingdom market.</p><p>For this reason, at the Employment, Social
Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary
Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government’s
concerns about the readiness of critical infrastructure required to implement the
MDR and the risk that some existing and new to market products will not be available
to patients as a result.</p><p>We very much recognise the benefits of the new Regulations
and the imperative of full implementation as soon as possible in the interests of
patient safety. Therefore, at EPSCO the Government emphasised the importance of finding
a coordinated solution at an EU level and we will continue to do what we can to influence
these discussions.</p><p>In parallel with this activity, the Medicines and Healthcare
products Regulatory Agency (MHRA) has been engaging with its notified bodies on an
ongoing basis to ensure that sufficient resources are in place and notified bodies
are prepared for the implementation of the new EU legislation. The MHRA is also offering
a substantial amount of resource to the EU in order to support and expedite the designation
process.</p><p>Through the Office for Life Sciences, the Government plans to work
with stakeholders to come to a shared understanding of the issues and discuss what
further mitigating action could be taken. Further engagement with industry will therefore
take place in the short term.</p><p> </p>
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