MD Class I transition period MDD to MDR - changes?

MDRResearcher

Starting to get Involved
#1
Dear all,

are there any changes in relation to defined transition for MD Class 1 from MDD to MDR?

We have separate opinions from 2 different CA responsible persons that state the transition period for MD Class 1 that do not include NB (self certified) has ended.
They expect that self certified MD Class 1 products, that was previously on the market with DoC according to MDD needs to be updated to MDR.

Can we, as distributor, place on the market MD Class 1 products that have DoC according do MDD dated before May 2021.?

Kind regards and thank you for all the available information.
 
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Billy Milly

Involved In Discussions
#2
In short, CAs are correct. Self-certified class I devices can only be distributed out of stock that was already already present in the market (placed on the market) before 26.5.2021.
 
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