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Manufacturer's responsibility to notify the NB regarding Medical Device End-of-Life


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ce mark and ce marking, end of life program for devices, notified bodies medical devices (nb-med)
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  Post Number #1  
Old 21st November 2016, 03:17 AM
eyalhend

 
 
Total Posts: 10
Question Manufacturer's responsibility to notify the NB regarding Medical Device End-of-Life

Hello all,
My company decided that a certain product (CE marked) will reach to its end-of-life.
In this essence, it would not be manufactured nor distributed anymore.

My question is with regards to the manufacturer's responsibility to notify the NB regarding the above:
1) In case company decides to keep the product registered under its CE certificate (it includes additional products having same technology)
2) In case company decides to exclude this specific product form the CE certificate

Great thanks in advance,
Eyal

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  Post Number #2  
Old 21st November 2016, 05:05 AM
Ronen E

 
 
Total Posts: 3,284
Re: Manufacturer's responsibility to notify the NB regarding Medical Device End-of-Li

Hi Eyal,

No strict regulatory obligation comes to my mind, though your contract with your specific NB might say otherwise. I would mention it to your NB auditor on your next surveillance audit, especially if you want that device off your EC certificate.

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
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