Hello Anon
Some labeling differences would be innocuous; others much more significant.
For example, if you wanted to claim to have NB approval for a degree of accuracy and precision in that extended range that the NB has already said is not supported by the evidence, I expect the NB would not be pleased, nor would the competent authority of the non-EU country.
If you believe the device does meet the requirements of the non-EU country, maybe you could collect data to demonstrate that, to the satisfaction of the NB.
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Anne LeBlanc
United States
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Original Message:
Sent: 30-Jun-2022 04:31
From: Anonymous Member
Subject: CE marked IVD products outside of Europe
This message was posted by a user wishing to remain anonymous
Does anyone have experience with CE-marked IVD products outside of Europe, where the non-EU country has different regulatory requirements/standards that a manufacturer needs to comply with that will lead to differences in the labeling?
E.g., the non-EU country require broader measuring ranges for the device than what the EU NB is willing to accept?
The non-EU country has, at the same time, a requirement for homeland approval, which in my company is interpreted as the CE mark must be on the device.
Any thoughts on how NB's looks at this?