J

jordan_elder

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#1
We currently have our CE mark for one of our medical devices (It's an IOL). However we have recently discovered a more cost effective inner package and are in the process of validating the new packaging. We have cytotoxicity data on the packaging itself and have proven that the IOL is safe and has no cytotoxicity.

Understandably we will have to do a process validation for the new packaging, transport stability re-validation, whole package integrity re-validation and a re-validation of the sterilization used. I was curious if anyone knows what the exact requirements are on re-validating the packaging since it is radically different. What additional biocompatibility testing is required or are we okay with just the cytotoxicity results and writing a justification on why it is safe? If the product does not leach would it be necessary to have any additional biocompatible testing? Thanks!:)
 
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#2
What additional biocompatibility testing is required or are we okay with just the cytotoxicity results and writing a justification on why it is safe? If the product does not leach would it be necessary to have any additional biocompatible testing? Thanks!:)

With regards to biocompatibility, you can apply a risk based approach to determine any new possible requirements according to 10993.
 

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