Biological testing at the end of the real time of MD

M

Manel Mou

Starting to get Involved
#1
#1
please I need your opinion in the following:
in the presence of real time stability study confirming the resistance of the packaging with no estimation of degradation and preservation of product specifications and performance, is it mandatory to test the initial proved biocompatibilty of a non sterile MD at the end of shelf life?

if yes, please can you guide me on the most relevant biological testing to be performed? The cytotoxicity for example?

THANKS IN advance for your help.
 
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planB

planB

Super Moderator
#2
#2
The requirement in ISO 10993-1:2018, section 4.7 is - quote:
The biological safety of a medical device shall be evaluated by the manufacturer over the whole life-cycle of a medical device.
Click to expand...
In case informed considerations of the medical device indicates that no potentially adverse degradation occurs during shelf (similar to ibid, 6.3.13 b), you might be in a position to argue that the initially evaluated biocompatibility remains established over the shelf life. Whether you would require experimental substantiation (by e.g. a cytotoxicity test) of your conclusion, depends on your specific biological risk assessment - there is no standard recipe.

HTH,
 
M

Manel Mou

Starting to get Involved
#3
#3
please I need your opinion about the following in the same context above,
if it is judged to conduct cytotoxicity testing on a MD as a biological endpoint , is it possible and acceptable to perform this testing on old samples of the MD already stored for shelf life testing and then we can obtain cytotoxicity results for the whole life-cycle of a medical device .
thanks in advance.
 
planB

planB

Super Moderator
#4
#4
[...] is it possible and acceptable to perform this testing on old samples of the MD already stored for shelf life testing [...]
Click to expand...
Yes, this is possible, and will (hopefully) experimentally substantiate your evaluation that storage conditions do not adversely affect your device's biocompatibility over the labelled shelf life.

HTH,
 
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