Regulatory
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IVDR Metrological Traceability
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IVDR Metrological Traceability
Hey Friends,
Has anyone ever had a product with applicable metrological traceability? I am working with a client and we are getting push back from the NB re: this section of our IFU. Any ideas?
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4 Replies
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Hi Ash can you be more specific as to what on the Medical Device requires Metrological Traceability ?
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It is a standalone control used to verify calibration of clinical lab equipment. The NB seems to want to see metrological traceability back to the original control material or some statement to that effect in the IFU.
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Hi Ash, also not sure if you intended to include any type of screenshot or anything but what specifically in the IFU were they pushing back on? Thanks!
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Hey Holly, sorry, I meant the metrological traceability section. No screen shot, we don’t have any verbiage for it yet.
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