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Q4 Single choice

Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

A
The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
B
Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
C
The manufacturer's experience level with the type of IVD medical device is limited.
D
The device incorporates well-established technology that is already present in the market.

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