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<p>The Medicines and Healthcare products Regulatory Agency (MHRA) does not approve
COVID-19 testing devices. Tests for professional use are subject to self-assessment
by the manufacturer before they may be placed on the market. Self-test devices are
required to be assessed for conformity to the regulations by an Approved or Notified
Body. In addition, tests must also meet the COVID Testing Devices Authorisation requirements.</p><p>In
exceptional circumstances, the MHRA can issue an Exceptional Use Authorisation (EUA).
The MHRA publishes the names of tests and other medical devices which have been granted
an EUA online. The MHRA does not currently have any outstanding decisions for EUAs.</p>
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