MHRA have requested that we remind members to engage with MHRA as soon as possible on matters relating to safety.
Where you think you may need to utilise the exceptional use authorisation route, or are unsure on vigilance obligations, we encourage you to contact MHRA directly for support. The EUA route can be used for any medical device or IVD which does not have appropriate conformity, not just covid-19 products.
If you have any questions or queries relating to vigilance, please use the MHRA vigilance email: vigilance@mhra.gov.uk.
