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UMDNS and GMDN Codes - When a Preferred Term has been Retired

fialor

Involved In Discussions
#1
Hi, I have a question regarding UMDNS and GMDN codes.
When a preferred term has been retired, what are the implications for a DoC (declaration of conformity) certificate for a manufacturer who used the retired term?
If there is a new DoC, will the manufacturer have to choose a new preferred term?
Thanks
Fialor
 
M

MIREGMGR

#2
That depends on the expectations and requirements of the recipient of the DoC.

If for instance the DoC is provided by an outside-EU device maker to an EU representative so that the EU representative can register the relevant devices with a national authority, the EU representative may require that the DoC be maintained to utilize only current terms.

In other contexts, perhaps the recipient of the DoC won't care.
 
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