And as I said before, even the particular standard requires clinical investigation, so the "well-established" here does not make much sense.
And this example is exactly why I worry about the "well-established" part. For a device manufacturer or someone without a deep knowledge of the device requirements (including standards) the "well-established" argument may seem good. But if the evaluator has a good knowledge (in this case the only needs to read the particular standard), this argument falls off quickly.
And this example is exactly why I worry about the "well-established" part. For a device manufacturer or someone without a deep knowledge of the device requirements (including standards) the "well-established" argument may seem good. But if the evaluator has a good knowledge (in this case the only needs to read the particular standard), this argument falls off quickly.
As the MDD says, placing a device in the category where a clinical evaluation is not necessary needs to be duly substantiated. To me that means that a manufacturer can't go by gut feeling - they need to study the background and gain that "deep knowledge" you mentioned. Is it less onerous than preparing a clinical evaluation (either with or without an investigation)? I don't know, the manufacturer should evaluate that and decide.
Last, for really well-established device categories there's usually a wide range of sources that can be relied on (books for example), even to the extent that you can show that a single source is an outlier.