Has NB-MED 2.5.2-Rec 2 Version 8 been withdrawn?

tehuff

Involved In Discussions
#1
Hi Covers,
Does anyone know anything about version 8 of MedDev 2.5.2 "Reporting of Design Changes and Changes of the Quality System" - I have found many web references to it but it appears that it was maybe withdrawn? What do you use to guide you regarding reporting changes in Europe since Rev 7 is no longer active either.....Thanks!
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
This may be significant - Does anyone here know anything about this? My Thanks in advance for any help.
 

rob73

looking for answers
#4
Tehuff
The best way is to talk to your notified body about changes which you feel may be significant.

This document might (or might not) help
www. nsai. ie/getattachment/Our-Services/Certification/CE-Marking/CE-Marking-for-Medical-Devices/RF-25-08-Rev-14--Substantial-and-non-substantial-change.doc.aspx - OBSOLETE BROKEN 404 LINK(s) UNLINKED
Rob
 
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sreenu927

Quite Involved in Discussions
#6
HEre is the Rev 8 attached that I can see from NB-MED guidance docs
http :// www team-nb.org/index.php?option=com_docman&task=cat_view&gid=17&Itemid=38 - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Above is the link.

However, Rev 7 is not withdrawn. From the MEDDEV docs link, it still shows Rev.7.

Regards,
Sreenu
 

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tehuff

Involved In Discussions
#8
Re: NB-MED 2.5.2-Rec 2 Version 8

Ok, now that I found the NB-MED document, I have some questions about applicability. Devices are class IIa and IIb and approved under Annex II. I am trying to define types of changes that a) require NB prior approval, or b) require notification of the NB.

Prior NB approval: substantial changes to the quality system or product range covered (per the medical device directive Annex II, 3.4)

Notification: ????? Do I follow 6.1 in the NB-MED 2.5.2-Rec 2 document? Per the tables on page 2 , it looks like changes to the device are not considered reportable for Class IIb devices unless they are approved under the Type Examination procedure (and not at all for Class IIa) - can someone please confirm I am interpreting this correctly?

Thanks!
 
S

SteveK

#9
As a follow up, if you now go to the NB-MED site, NB-Med 2.5.2/Rec2 Rev8 (23.7.2009) no longer seems present. In fact there are no guidance documents there from 2009. Obviously it is available via this thread (as indicated I also previously downloaded it {in 2009} from the NB-MED site when it was available there). Is it now in the members? only section? If so this seems a little strange as it is directed at manufacturers. If it is no longer ?published? on the NB-MED is it no longer a valid NB-MED guidance document (regardless if it is out there in the ether and being referenced at various NB sites/documents)? Am I missing something? It is strange that a document that is still available i.e. Technical Documentation NB,-MED/2.5.1/Rec5, references NB-Med 2.5.2/Rec2. Does it mean overall that manufacturers are now freer to decide what a ?substantial change? is and what they should report to NBs? Were NBs going into overload on ?substantial changes? being reported?

Sorry about so many questions in one go.

Steve
 
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