Requirements for Implantation Records/Cards - Class III, Implantable (not active)

J

jampot

#1
Would anyone be able to direct me to the relevant standard relating to the requirements for providing medical device users with implantation records/cards (i.e a card/sticker to go in the patients medical records following implantation).

If it is any help the device we manuacture is a Class III, implantable (not active), nor is it a permanent implant, but has a >28 day residency period

Many thanks
Jampot
 
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