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

E

eyalhend

#1
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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Ronen E

Problem Solver
Staff member
Moderator
#2
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.
 
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