Clinical validation under MDR

Galac

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We have a medical device undergoing MDR certification (software) for which the clinical evaluation by the NB has been completed (with a favorable opinion), but not yet CE marked. There are still a few issues to be resolved in the evaluation of the technical file.
This device is intended to be integrated into another medical device (which is CE marked under the MDR), for which the integrator is responsible for obtaining the CE certificate under the MDR.
What are the possible paths of clinical validation and usability for the final integrated device? (the less burdensome?)
Thank you.
 
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