Contents
3.The notified body shall complete the assessment of a planned substantial change to the quality management system or to the device range covered by an EU quality management system certificate or an EU quality assurance certificate, and the assessment of a change to the approved device covered by an EU technical documentation assessment certificate or an EU type-examination certificate, in the following maximum timelines:
(a)30 days for reviewing the proposed planned change, starting on the day the notified body receives from the manufacturer information on the planned change with completed documentation, and ending on the day in which the notified body notifies the manufacturer of the decision on whether any additional conformity assessment activities are needed or of the approval of the planned change;
(b)90 days for the additional conformity assessment activities of the planned change, starting on the day the notified body initiates, where necessary, the audit programme’s first activity or on the day the notified body initiates the assessment of the technical documentation, whichever is the earlier, and ending the day the notified body notifies the manufacturer of the approval of the planned change;
(c)20 days for issuing the supplement to the concerned certificate(s), where necessary, starting on the day following that of the notification of the approval of the planned change as referred to in point (a) or (b), and ending on the date the supplement to the concerned certificate(s) is issued and entered in Eudamed, in accordance with Section 4.8 of Annex VII to Regulation (EU) 2017/745 or Section 4.8 of Annex VII to Regulation (EU) 2017/746, as applicable.
Where a new conformity assessment procedure is necessary, the timelines referred to in paragraph 2 shall apply.
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