Bildquelle: Pilgrim Software

Die Notified Body Operations Group (NBOG) veröffentlicht das Dokument zur Prüfung der technischen Dokumentation (NBOG BPG 2009-4) in dem auch Bezug auf die Prüfung der klinischen Daten genommen wird. Es heißt dort:

The NB should assess the validity of the clinical evaluation and should verify that the device has met the claimed performance as outlined. The documentation provided by the manufacturer should contain all necessary data according to MEDDEV 2.7.1 [3] and / or GHTF SG 5 documents [4, 5] to allow for a proper review of the clinical evaluation done by the manufacturer.
The NB reviewer should assess the clinical investigation data and / or the literature review assembled and the validity of conclusions drawn by the manufacturer.
The Design Dossier Report should include
– assessment of the clinical safety and performance
– conclusion (the NB should justify and document each step of the decision making process; see [3] for further explanation)