'If the supplier of the material is a crucial supplier (definition see [5]), that change is substantial.
If the supplier or vendor of the material changes, but the material meets the manufacturer's previously reviewed specifications and acceptance criteria, with the exception of human or animal derived materials, then that change is not substantial.'
This is an algorithm to determine whether a change is substantial. Based on the question, I infer that your device does not use "human or animal derived materials". If so, my response would be different.
There is an assumption that you have classified each of your suppliers as crucial or not following the definition in [5].
There are four cases here, and the algorithm does not do a good job of differentiating among them. (A more detailed analysis has eight cases, by adding whether the supplier is critical or not. I'll mention this below.)
Case 1 – The material changes & the supplier changes
Case 2 – The material changes & the supplier is unchanged
Case 3 – The material is unchanged & the supplier changes
Case 4 – The material is unchanged and the supplier is unchanged
The first sentence is an explicit instance of Case 2, which says that if the supplier is critical, then the change is substantive. Presumably it also means that if the supplier isn't critical, then the change is not substantive.
The second sentence is an explicit instance of Case 3. The material is unchanged (meets the manufacturer's previously reviewed specifications and acceptance criteria) but the supplier changes. In this case, the change is not substantive.
This covers two cases explicitly and one implicitly. I'll leave the remaining five cases as an exercise to the reader. Hint: Make a table with 8 rows and 4 columns. The row headings are material changes, supplier changes, supplier is critical, and change is substantial. Populate the cells with Yes or No. For the first three columns, be sure to cover each combination of Yes and No. For the fourth column, determine if the change is substantial, Yes/No. I'm not convinced the excerpt has enough information to complete the table.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 17-Aug-2017 20:22
From: Rashmi Pillay
Subject: Change in critical supplier
Hi ,
Can somebody interpret the below section from the Significant change guidance for notified bodies for me .It mentions :
'If the supplier of the material is a crucial supplier (definition see [5]), that change is substantial.
If the supplier or vendor of the material changes, but the material meets the manufacturer's previously
reviewed specifications and acceptance criteria, with the exception of human or animal
derived materials, then that change is not substantial.'
So does it mean that for non-implantable devices that have a short duration of contact with body tissues , when the crucial /critical supplier changes but the material specification remains the same, it is not a substantial change?
The guidance also mentions 'When a critical supplier´s manufacturing process, facility or equipment changes, this is normally substantial unless otherwise justified'.
This is confusing..
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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