Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020?

D

DRA

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#1
#1
Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020?
 
GAGEpack - Gage & Calibration Management
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M

monoj mon

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#2
#2
Although MDR implementation is delayed until May 2021, you better talk to your notified body directly to know whether or not they are willing to accept new submission under MDD. For example, TUV SUD has mentioned that they are taking only limited application under MDD until the end of October, 2020.
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Raisin picker

Raisin picker

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#4
#4
You have to ask them. I'd guess that most NBs take new products for certification when they can be convinced that the technical documentation can be assessed positively until May 2021. So, if you submit the n+1 product to your NB, or can provide the certificates from your previous NB, you should be able to find someone. If you're completely new (regarding European regulations), you might face more difficulties.
If you're asking because you can't provide the files by October, then submit to MDR and forget about MDD.
 
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