@ Ronen,
Thank you for the suggestions.Also thank you for the supplier information. I sent them a mail regarding my query and hope to hear from them soon. <snip>
Hi Ravi,
If you can justify that changing the component's shape doesn't alter its biocompatibility status, you generally don't have to re-test or otherwise show compliance. For example, die cutting out of a supplied (already certified) sheet is likely to pass, but injection molding typically won't because the high temperatures, shear and pressure might cause significant changes.
As far as I know, position on the body doesn't affect ISO 10993 requirements, as long as we're only discussing intact skin.
The "formal" way I know for "getting away with it" is contacting one of the accredited 3rd party ISO 10993 test labs, and asking for a written opinion from their expert toxicologist. Otherwise it's just trial and error - document your justifications and see what happens when you make a regulatory submission / go through audit (not recommended but might still work).
You are very welcome to send me a private message if you're interested in further specific consultation regarding sourcing this component / material. Other than that I'll be glad to answer any general questions here.
Cheers,
Ronen.