Technical documentation for CE marking as per EU MDR

Описание: MDR is new legislation and for initial approvals, a complete submission with all the relevant Technical Documentation included is required even if the device was previously certified under the MDD or AIMDD
A subset of the information contained in the technical documentation is used by the manufacturer when submitting the device to the NB for pre-market or post-market conformity assessment activities.
The technical documentation should be structured and presented, in such a way, as to facilitate its review and assessment by the NB
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