For me this shows that the conformity assessment in Europe is just save, if the companies want to be safe. There is always the possibility to show correct things and act false, if you want to.
But what else can be done? The only "full safety solution" would be a part to part control, made by government or other third parties with all the knowledge which is necessary t0o prove safety of such product. But I hope, this will never happen. The most important thing now is, that this case is completely investigated by competent authorities and that the responsible persons are blamed for what they have done.
But what else can be done? The only "full safety solution" would be a part to part control, made by government or other third parties with all the knowledge which is necessary t0o prove safety of such product. But I hope, this will never happen. The most important thing now is, that this case is completely investigated by competent authorities and that the responsible persons are blamed for what they have done.
Medical devices regulatory systems are created to ensure safety and efficacy (and whatever else) and they are usually created with the premise that the companies will be following them (they are usually laws). In this way, they are created for the "right" manufacturers, the ones which are going to comply.
It's primarily the responsibilities of the manufacturer to comply. It's also the primarily responsibility of the manufacturer to perform the conformity assessment of his compliance.
There may be an additional conformity assessment by regulators, but this is usually related to an "sample" audit or inspection, or inspection of a summary technical documentation, or another "general" review. I mean "general" here in the sense that, as the manufacturers already have to comply and assess conformity, an inspection, audit or review by a regulator is trying to determine if it "seems" that the manufacturer is really complying (and people can begin saying that, for example, the FDA or whatever inspection is more detailed or whatever, however even theirs is a sample).
Note, again, that it's expected that the manufacturer "wants" to comply (because they have to). So, if a manufacturer does not want to comply, they can simply mask what they are doing for example.
Do regulatory systems prevent that bad manufacturers (the ones which do not want to comply) exist? No, the systemas are created to the good ones. The way to deal with bad manufacturers is really the police (I'm saying this in a broader view).
Anyway, the only way that I know of, of a regulator really making sure that things are going to be followed (which, again, is not the responsibility of the regulator) is to put regulator staff on each manufacturing plant, 24 x 7. Even this would not really guarantee that things are followed
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