SteveK

Quite Involved in Discussions
#1
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
 

pkost

Quite Involved in Discussions
#2
Re: NB-MED, NBOG, IMDRF and MEDDEV, is there a hierarchy?

The only requirement is the directive, everything else is a suggestion of best practice which you can choose to disregard if you are able to prove that your method is safe and effective.

I believe the reason why guidance is generally taken as a requirement is becuase it is considered that if a group of industry recognised experts sit down and decide what is best practice, it is unlikely that anyone else is going to come up with something safer and more effective. Therefore if you are not following guidance you are not following best practice or using state of the art

That being said, of the guidance issued, in my mind they have the following order of prescendence:

1. MEDDEV: issued by the EC (if you object to a decision by the EC your next step is european courts who don't issue guidance)
2. NBOG: agreed by EC and member states to set up NBOG, EC are members along with CA's
3. Team NB: besides hating the name, this appears to be a voluntary group of notified bodies (not even all of them) that discuss and agree approach

I'm not sure if ranking them is beneficial though as I'm not aware of any contradictions!

You didn't ask about CMC which seems to have gone quiet of late and likes to issue decisions that contradict harmonised standards!
 

MIREGMGR

Inactive Registered Visitor
#3
Re: NB-MED, NBOG, IMDRF and MEDDEV - Is there a hierarchy?

IMDRF, formerly GHTF, was/is a discussion organization founded at the behest of the pro-harmonization faction within US FDA, to the best of my knowledge. They don't have any formal place in an EC regulatory hierarchy.

WHO is not a medical device regulator. They're a department of UN and speak to national and multinational health statistics/outcomes and what affects them. As a managerial/bureaucratic body that primarily works on mass provision of care and paying for it, they do not speak as subject matter experts on device regulatory matters, other than perhaps the interaction between device costs and how much care can be provided.

Your list also could include EK-Med / ZLG.
 
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