Change in Lot Release Specifications - Definition of "Substantial Change"

JB0424

Starting to get Involved
#1
Hi all.

I am seeking information on when a change to a class III device is considered substantial, and therefore requires notification to my notified body.

I have a product that has changes in some specifications for lot release, but not performance specifications. The specifications in question are important because they dictate our ability to meet performance specs at time of use and shelf life.

The lot release specifications are being relaxed from where they currently are. I suspect this will likely need to be sent as a notice of change to my notified body, but I cannot find any guidance documents defining when a change is substantial and notification is required. Is anyone aware of documents that offer guidance in this decision?

Thanks!
 
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JB0424

Starting to get Involved
#4
Re: Change in lot release specifications - substantial change?

Thank you for the response. The guidance appears to be for Canada. Is this applicable to EU as well?
 

MDD_QNA

Involved In Discussions
#7
Re: Change in lot release specifications - substantial change?

Is the change also a significant change if we didn't file the tolerance specification to the authorities? However, the actual value has been submitted to the authorities and the tolerance is written in the Final Inspection testing and it is a crucial parameter for us.
 

Chrisx

Involved In Discussions
#9
Page 9 of the NBOG guidance states:

"Changing a test acceptance criterion or test method or removal of test acceptance criteria, inprocess inspection, or final inspection is considered substantial (5.1 only)."

5.1 of the guidance is for product changes.
 
M

maxximase

#10
For the Notified body see the following document: NB-MED-2_5-2_Rec2_Reporting of design changes and changes of the quality system

Amjad Rana
I think the notified bodies are supposed to apply this guidance: NBOG_BPG_2014_3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.pdf
So both the NB-MED and NBOG documents cover the same topic, but I have not yet performed a line by line gap analysis to see if the requirements vary at all. How do we know which of these documents takes precedence?
 
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