The Team-NB conducted a second survey this year to establish the number of Notified Bodies that applied for the designation under the MDR.
So far, 65% of the Team-NB members (17 bodies) and 45% of non-members participating in the survey (all together 33 bodies) submitted their application to be designated against the MDR. Among the Team-NB members, 44% of them applied for a wider scope, the other 57% for the same scope and none of them for a smaller scope. Furthermore, the survey showed that 54% had already had the Joint audit.
This brings all applicants closer to the eventual approval in being operational as conformity assessment body under the new Regulation.
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