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Holly replied to the discussion IVDR Metrological Traceability in the forum Regulatory 4 months ago

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!

Jude replied to the discussion IVDR Metrological Traceability in the forum Regulatory 4 months ago

4 months ago

Reply to IVDR Metrological Traceability

Hi Ash can you be more specific as to what on the Medical Device requires Metrological Traceability ?

Ash started the discussion IVDR Metrological Traceability in the forum Regulatory 4 months ago

4 months ago

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?