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<p>The agreement of an implementation period will mean that the Medicines and Healthcare
products Regulatory Agency (MHRA) will continue to be recognised as a European Union
competent authority designated under the EU Directives for medical devices, in vitro
diagnostic medical devices and active implantable medical devices, during this period.</p><p>
</p><p>This is also the case for the new EU Regulations for medical devices and in
vitro diagnostic medical devices, which both entered into force in May 2017.</p><p>
</p><p>It is possible for a single organisation to have individual notified bodies
designated in more than one Member State. The authority within each Member State is
responsible for notified bodies based in its own country.</p><p> </p><p>The MHRA is
responsible for the designation and monitoring of notified bodies in the United Kingdom,
which the response to Question 196736 refers to.</p>
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