My Lords, I am very glad to support my noble friend in her Motion. I want to put two points to the Minister. The context of this SI is the poor quality of many tests. Paragraph 7.2 of the Explanatory Memorandum makes the point that, during public procurement of lateral flow tests for the NHS,
“only 25% passed through all stages of validation including assessments of performance and quality standards.”
That is a pretty shocking statistic. Can I take it that most of these tests came from China? We had an Oral Question on this from the noble Lord, Lord Alton, only a few minutes ago. That being so, can the Minister assure me that Uighur slave labour in Xinjiang was not used in the manufacture of those tests?
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I want to go on to the issue of poor-quality tests in general. In Grand Committee, the Minister said he would not settle for low-quality CE-marked tests that manipulated their instructions for use or constructed their own rigged validation. This, of course, is a very interesting insight into the way that devices are regulated at the moment, through the current CE marking process. In relation to most Covid-19 tests, this essentially involves a self-certification process, in which manufacturers affirm that their products meet the relevant standard. Many of the CE-marked products that have been reviewed previously have had insufficient or poor data sets that do not accurately reflect how a test product performs. This data and evidence do not facilitate accurate assessment of the product by the end-user and can be misleading.
This seems to me to raise two points. First, we should do everything we can to ensure the manufacture of high-quality tests in this country, rather than rely on imports from countries whose human rights record is nothing but utterly deplorable. Secondly, it must call into question the whole future of CE marking. I want to ask the Minister whether we can take the action being taken by the Government—essentially applying their own standards to these tests, because the current CE marking is not sufficient—as a precedent for the future. Does it lay the foundations for a new regime in relation to the regulation of medical devices?