2009 – NBOG-document for evaluation of technical documentations

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The Notified Body Operations Group (NBOG) notified bodieshas released the document for evaluation of technical documentation (NBOG BPG 2009-4) which refers back to evaluation of clinical data.

 

Picture Source:
Pilgrim Software

They write:

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)

Notified Body

Notified Bodies (Benannte Stellen) of the European Union are defined as follows in 3 | mpg | juris Nr. 20 MPG:

A notified body is a body designated to conduct tests and issue certificates in connection with conformity assessment procedures in accordance with the ordinance referred to in Section 37,
sub-section 1 and of which the Commission of the European Union and the States Party to the Agreement on the European Economic Area have been notified by a State Party to the Agreement on the European Economic Area.

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