Blog

23Oct

New MHRA guidance on COVID-19

MHRA Guidance and regulatory flexibilities: Please see the regulatory flexibilities page for guidance for industry on flexible approaches to regulation we are taking during COVID-19.

New or updated guidance published on their general guidance page for industry:

Updated guidance:
How tests and testing kits for COVID-19 work
Details of update:
They have added a Target Product Profile for Laboratory-Based SARS-CoV-2 Viral Detection Tests.
Updated guidance:
Medical devices given exceptional use authorisations during the COVID-19 pandemic.
Details of update:
They have updated the list of medical devices given exceptional use authorisations and the list of devices no longer covered.

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