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Manufacturing site expansion - When to notify your NB

#1
Hi All,

My company are building an extension to their manufacturing facility which requires a significant change notice to be made to our Notified body. Just wondering at what stage of the construction do you send in your notifications? Do you send in as soon as the construction begins even though it could be a long process?

Many thanks!
 
#2
There is no straight forward answer to this, especially in the days of transitioning from MDD to MDR.
It also depends on how this change could effect the product quality, and wether or not you need their feedback as input to the construction work. Best to contact them and see what they have to say. Generally speaking, they don't like surprises.

Shimon
 

Philip B

Involved In Discussions
#3
Check with them first that they want to be formally notified, I checked something recently, expecting them to say yes but was pleasantly surprised when they said no. I always think telling them as early as possible is best practice, don't under-estimate their ability to slow down a project due to their lack of resource, poor prioritisation, last minute cancellations etc. Tell them early and keep reminding them!
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
I've told my contact at the NB as soon as the project was approved with an estimated completion date.
Then they came back and said "update us with the status when we schedule the next inspection".
Our customers were more concerned as they wanted to see qualification for any new/moved equipment, etc.
 
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