You're splitting hairs. How much evidence do you need?
Some evidence would be a start
As should be apparent from its position in the sentence, my "We just don't know" statement related to whether or not an EEA importer had taken the necessary steps to support/justify the CE marking. If you have
any actual evidence (either way) in relation to that, I'd be interested to hear it!
With you pharmaceutical background, what would you say if 100% of an imported shipment (however small) of a drug was clearly dangerous, and carried misleading claims of compliance with the relevant legal requirements? Would you not be demanding further investigation?
I wouldn't really say that I have a 'pharmaceutical background', although it is certainly true that I have had a lot of involvement with pharmaceutical products.
As I've said, I don't know how the rules work in terms of other types of product (e.g. electrical ones), but the situation with pharmaceutical products imported into the EU from outside the EU is strictly and specific regulated in a way which is probably not the case with many other types of product. In particular, one is not allowed to rely on the Certificates of Analysis, or other documentation, provided by the manufacturer (or anyone else outside of the EU). Instead, each shipment has to be tested in the EU and then 'released' by an approved responsible EU person known as a 'Qualified Person'.
Such testing would obviously never be based on just a sample of two items. However, if one, let alone two, specimens of a drug (e.g. tablets) were found to have 'dangerous defects' there would certainly be extensive further investigation (and, almost certainly, rejection of the complete batch), whether those specimens represented 100% or 0.01% of the sample examined. Needless to say, much more common is to find that a batch is 'slightly out of spec' (which is often essentially a statistical issue), rather than that it contains 'dangerous defects'.
However, at least initially, there would
not be accusations, and usually not even any suspicion, that there was anything 'misleading', let alone fraudulent, about the Certificates of Analysis and batch-release documentation associated with the batch/shipment - merely a suspicion that 'something had gone wrong'. You have to understand that a drug manufactured outside of the EU will not be 'approved' ('licensed') in the EU unless/until the relevent EU regulatory authorities have inspected/ audited/ approved (themselves ,or via a third party) the manufacturing facility (wherever it is) and their systems/ processes/ practices. If (which fortunately is rarely the case, even with 'counterfeit' products) the investigation were to reveal that the batch was clearly totally incompatible with the spec of the product and the C of A provided by the manufacturer, then we would be into the scenario you are postulating. The UK medicines regulatory authority has, in fairly recent times, revoked the 'approvals' ('licences') of all pharmaceutical products manufactured by one particular company in India for such a reason.
However, as I've said, pharmaceutical products are much more highly and formally regulated than, say, consumer electrical products, so I'm not sure there are many good parallels. I doubt, for example, that there is any body in the EU which is regularly inspecting the manufacturing facilities and systems of those who produce electrical items in China, or that many importers of such items always test them before releasing them into the market!
Yes, it is possible that the importer (if there actually is one) of the OP's purchase has fulfillled his legal obligations, but the balance of probability is that he has been mislead by the Far Eastern supplier into accepting a certificate that has no legal standing in the EEA.
Quite, as I said (and you say), it's possible. The trouble with your 'balance of probability' view is that it's not much of a 'balance'. As above, it is based on some circumstantial evidence but absolutely no knowledge of what the importer did or didn't do!
By the way, I accept your point about skin colour - Caucasians are responsible for a disproportionate numer of corporate frauds in London!
I assume that's what you meant?
Of course, that's one example - it works with any skin colour!
Kind Regards, John