The below is an update from the MHRA – 15/06/2020 – on the Coronavirus situation
For more information on Coronavirus, click here
This notice updates you on details of recently published guidance for industry on the coronavirus (COVID-19) pandemic and how we are working closely with our healthcare partners to contribute to the essential global action needed to protect public health at this challenging time.
We would welcome your further feedback on what other information you would find useful – please email engagement@mhra.gov.uk
Regulatory flexibilities
We continue to work with stakeholders to develop, refine and publish updates to our regulatory flexibilities page. We have added information on audits of Notified Bodies and manufacturers in the medical devices section.
Other guidance for industry
New or updated guidance that we have published on our general guidance page for industry since the last edition of this email:
- Updated guidance:
Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with COVID-19. Advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic.
Details of guidance:
This guidance is on how to use the current regulatory flexibilities or how to get an exceptional use authorisation from MHRA for software or app intended specifically for the pandemic response.
- Updated guidance:
How tests and testing kits for COVID-19 work. The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Details of guidance:
We added Target Product Profiles (TPP) for Enzyme Immunoassay (EIA) antibody tests to help determine if people have antibodies to SARS-CoV-2.
Contacting the MHRA
Most of our workforce is working from home, although National Institute for Biological Standards and Control (NIBSC) is continuing essential laboratory activities on site. If you need to get in touch with us during this period, please email or phone us.
For more information please visit mhra.gov.uk