Extension to shelf life of new product under MDR

#1
We have a new product currently under technical file review (MDR). Our shelf life and reports in the technical file support a 1 year shelf life, but we have just completed 3yr AA testing. I can't find any information on what documentation and/or notifications (beyond updates to labeling, technical file, etc.) are required to update our shelf life. Can anyone advise? Thanks!
 
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#2
You may want to risk assess the potential impact of an extended shelf life also for (but not limited to):
  • biocompatibility / stability of the packaged product
  • functionality of the packaged product
  • continued legibility of labels and direct markings on the product (including UDI codes if applicable)
In case your product is already CE-marked and depending on your product class, no additional notification to your notified body might be warranted in case you employed the same methods of establishing a new extended shelf life, that your notified body has reviewed before for the initial shelf life of one 1 year.

Hope this helps,
 
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