RE: Is it just me who thinks it’s odd EU sales being delayed for MHRA approval?19 May 2021 07:42
Hi JDT - I’ve been wondering about this too.
There’s loads of guidance on this within in the U.K, but I found this the easiest to get my head around -
https://ec.europa.eu/health/sites/default/files/md_sector/docs/covid-19_ivd-qa_en.pdf
In summary, this suggests to me that a notified body (like the MRHA) need only be involved if the test is intended to be used as a self test. That’s confusing, of course, because the RNS made clear that we are CE marking for professional use only???
From q17 in the link
The precise role of notified bodies for different types of products is described in the relevant legislation. For IVDs under Directive 98/79/EC, they are involved in the assessment of self-tests (intended for lay users) and certain high-risk devices listed in Annex II of Directive 98/79/EC17. For COVID-19 tests, notified bodies are not involved in conformity assessment of tests intended for professional use, as these are not listed in Annex II. However, they do have a role for COVID-19 self- tests (i.e. those intended for lay users). For these tests, the manufacturer must submit an application to a notified body for the assessment of the design of the device, e.g. the suitability, for the lay user, of handling and information included on the label and instructions for use. Following a positive assessment, the notified body will then issue an EC design-examination certificate18. The assessment is usually by document review and not by physical testing of the device.
Notified bodies are not responsible for affixing the CE marking on the device, as this is the duty of the manufacturer. Notified bodies only issue the certificate for the specific activity that they have carried out. For a COVID-19 self-test, the manufacturer will not be able to affix the CE marking until the notified body has issued the relevant EC design-examination certificate.”
There is no doubt an obvious explanation, I just don’t know what it is!