RE: Self Test Approval29 Oct 2020 11:53
"The guidelines for self test approval is that the device should be certified by a notified body as meeting the guidelines for an IDV for self test use. So the actual approval and CE marking for sale will be granted by the notified body CE or EC marking the product as confirmation of conformity with the guidelines. A notified body is an independent qualified person. For Mologic Antigen tests this is likely to come from Liverpool School of Tropical Medicine, for UK RTC it is Ulster. In normal circumstances the CE marking would enable the test to go on sale for self test. What happened with the Antibody tests is MHRA stepped in with a legislation override banning the sale of Antibody tests for self use on the basis that they were unhappy with the accuracy. It seems for some reason the government are not ready for us to have access to home use antibody tests until they are ready, which is why we are waiting on MHRA approval because of the legislation override currently banning such devices. The ban is on the manufacturer not the vendor, which is why the Visitect tests could be ordered by an individual and used because the manufacturer has geared the product for professional use and sold as such.
Once an Antigen test has received CE marking for self use, this can currently go on sale as such as the MHRA override only applied to antibody tests, unless of course they issue a similar ban. "
I'm afraid you're not quite correct MB.
The documents you link to are based on the EU Directives for Medical Devices. The simple position is:
- all in-vitro devices (IVD) other than devices for self-testing or devices appearing in Annex II, the manufacturer can CE mark when they meet the prescribed conformity requirements;
- IVDs appearing in Annex II list A and Annex II list B are either subject to either audit or examination by the notified body before they are CE marked (the exact nature of what is required is laid out in Annexes III-VII);
- all self-testing IVDs (excluding those which appear in Annex II) requires specific examination by and approval from the notified body.
We also have to take into account that Covid 19 is a notifiable disease under the Health Protection Regulations 2010. This means there are further controls on testing and reporting.
Molecular and antigen tests are used for testing for active infection. There is a legal obligation on those carrying out such tests to report positive results for the purposes of public health. This is why molecular and antigen tests are currently restricted to lab or professional POC use only.
The government will not allow the general sale of antigen tests in the UK, as they will not be able to enforce the HPR2010 if they do. Antigen (and molecular) testing will remain restricted for that reason.
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