MDR CE Expiration Date

G

GalitSa

Registered
#1
#1
Our NB is very busy and we concern that we will not be able to renew our MDR CE certificate in time (it expires in January 2024).
We have one product sold in UK, would it be possible to rent a warehouse in Europe and put safety stock there under the previous certificate
 
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K

kormach

Starting to get Involved
#2
#2
I am afraid you need to have a distributor - you need to place your devices on the market before expiration date of MDD certificate. The distributor then can sell the stock till 27th May 2025.
 
M

Mazza

Registered
#3
#3
You can stock-build, but all stock must be assigned to an offer or agreement for transfer of ownership to an EU customer and must be manufactured prior to your certificate expiring.
We have been stock building for the last 4 months against forecasted POs from our EU customers which will cover them for the next 6 months as our CE cert expires in a couple of weeks time.
 
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