S
SteveK
There is NB-MED/2.5.2/Rec2 ?Reporting of design changes and changes of the quality system? and now we have NBOG BPG 2014-3 ?Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System?. The latter document references the former. These may be guidance or recommendation type documents, but Notified Bodies appear to see such documents as a requirement (mandatory?). In this example then which would take precedence? We also have MEDDEV and IMDRF (formally GHTF) documents. Again is there any hierarchy in these ?guidance? documents, especially where there is overlap? Then there are further medical device related documents that are issued by other bodies WHO, IECEE etc.
I would just be interested in any comments.
Steve
References:
http://www.team-nb.org/documents/2011/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf
http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
http://www.imdrf.org/documents/documents.asp
http://www.who.int/medical_devices/safety/en/
http://www.iecee.org/Operational_documents/od-cb_index.html
I would just be interested in any comments.
Steve
References:
http://www.team-nb.org/documents/2011/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf
http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
http://www.imdrf.org/documents/documents.asp
http://www.who.int/medical_devices/safety/en/
http://www.iecee.org/Operational_documents/od-cb_index.html