RE: MHRA Antigen17 Feb 2021 15:59
"It does need approval Chuggley. Surescreen have already got emergency approval as you have noted previously so looking good for immediate approval once the tests get through evaluation. Doesn't really make a difference now does it? "
I think people are getting a little confused over what approvals are required. Not unsurprising as much of the process has been made up on the fly by PHE and MHRA over the last year...
SureScreen has three antigen tests, all of which are CE marked for professional POC use only. One of those tests has also now been through the PHE assessment process which enables it to be purchased by HMG outside of an MHRA EUA.
Mologic has an antigen test, which is also CE marked for professional POC use only, and which is currently being TTd to ODX (who will then independently UKCA/CE mark it). As far as I am aware, this test is also in the PHE assessment process which, when complete (obviously assuming it passes) will enable it to be purchased by HMG outside of an MHRA EUA.
MHRA EUA only applies where the device is not CE marked and/or has not passed the PHE assessment.