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Keeping up with "State-of-the-Art" & updated Standards
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Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
Keeping up with "State-of-the-Art" & updated Standards
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  Post Number #9  
Old 20th September 2017, 11:16 AM
Mark Meer

 
 
Total Posts: 667
Re: Keeping up with "State-of-the-Art" & updated Standards

Quote:
In Reply to Parent Post by jon.loo View Post

But won't the requirements to meet the essential principles still be consistent from pre- to post- market? In this sense wont the need to conform to principles considered to be state of the art still be required for those in "post-market" phase?
The regulations use the language "...shall be designed and manufactured...".
So:
  • If the device is in a design phase, state-of-the-art applies.
  • If the device is being manufactured, state-of-the-art applies.
  • If a given unit of the device is in the field (has already been distributed), state-of-the-art does not apply - the assumption being that it was state-of-the-art at the time it was designed and manufactured.
Thanks to Mark Meer for your informative Post and/or Attachment!

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  Post Number #10  
Old 21st September 2017, 04:03 AM
pkost

 
 
Total Posts: 773
Re: Keeping up with "State-of-the-Art" & updated Standards

Regarding post market obligations, you should consider that the product at time of release is "safe and effective". An update to a standard does not make it less safe or effective.

If authorities expected recalls whenever a standard was updated and an existing product could no longer comply it would send costs skyrocketing and in all likelihood result in continual out of stocks for critical products.
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  Post Number #11  
Old 21st September 2017, 06:58 AM
kreid

 
 
Total Posts: 52
Re: Keeping up with "State-of-the-Art" & updated Standards

No, you just need to ensure that you use state of the art during design and development, as said above, - pre market activities.
Once on the market your post market activities demonstrate that your device remains safe and effective.
If anything in post market surveillance indicates that your device has problems then you would probably update the device and hence apply the current state of the art to your design change - pre market activities.
  Post Number #12  
Old 22nd September 2017, 11:41 AM
jon.loo

 
 
Total Posts: 8
Re: Keeping up with "State-of-the-Art" & updated Standards

But based on the statement that if the product is manufactured, state of the art applies. So after R&D phase and placing in market, as long as production is still ongoing, state of the art still applies? In a sense it is still considered a requirement until the product is obsolete?
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