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

DRA

Starting to get Involved
#1
Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020?
 
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monoj mon

Trusted Information Resource
#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

Quite Involved in Discussions
#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.
 

Parul Chansoria

Founder, Elexes Medical Consulting
#5
According to Article 120 (2-4), an additional conditional transition period is possible, but only for devices that still have a valid (MDD) Notified Body certificate in May 2020. Those devices can continue to be placed on the EU market for CE mark application and put into service as long as their certificate is valid. This additional transition period is limited: Placing on the market date for MDD-certified devices ends in May 2024, and putting MDD-certified devices into service ends in May 2025.
There are several conditions like the manufacturer must have a valid MDD certificate for the device, the manufacturer must also comply with the new EU MDR requirements for post-market surveillance, vigilance, and registration - you must consider those.
 
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