Reprocessing of an accessory for a medical device

#1
I have a question about reprocessing requirements under MDR
If a reusable ‘’product’’ is an accessory to a medical device
  • what are the reprocessing requirements under MDR? The same as for the medical devices?
  • Could I use equivalence to a previous model and tests and validation we have already performed or do I need to perform from scratch?
Thank you
 
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planB

Super Moderator
#2
bill,

the requirements are defined in ISO 17664-1:2021 for (semi-)critical devices and ISO 17664-2:2021 for non-critical devices. In case your reprocessing validation is state-of-the-art and has been performed on a predicate device that is representative, then you might be in a position to "adopt" your candidate device into your existing validation.

HTH,
 
#3
thks planB! indeed we are working under 17664 so you think I should give it a try and ftry to prove that validation for the previous device (which has been withdrawn from the market) is still stateoftheart? thks again!
 

planB

Super Moderator
#4
Without knowing the details of your validation, I cannot make an informed recommendation, other that saying that in principle, your suggestion might be possible, even though a withdrawn predicate might turn things more complicated.
 
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