Change in address for critical supplier - does NB need to be informed?

franklymissshankly

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#1
Our critical supplier is changing their site location. Do we need to notify the Notified Body that provided us our CE certificate about this? Their manufacturing process or equipment will not change. Thanks
 
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Sidney Vianna

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#2
Have you read the Terms and Conditions of your contract with the NB? What about the conditions for certification validity maintenance that should be spelled out in the actual certificate or it's appendices/attachments? While your supplier might claim no process changes, it is possible that new employees (and it's inherent risks) will be part of the re-location.
 
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franklymissshankly

Starting to get Involved
#3
Have you read the Terms and Conditions of your contract with the NB? What about the conditions for certification validity maintenance that should be spelled out in the actual certificate or it's appendices/attachments? While your supplier might claim no process changes, it is possible that new employees (and it's inherent risks) will be part of the re-location.
Sidney, thanks for the insight. The actual certificate and appendices have no such conditions but we'll have to check the actual contract. But say the NB did not mention any such changes in their contract, would it be considered a "significant change" under the MDD and would need to be notified? We did provide the NB the old address for the critical subcontractor/supplier.
 

Ronen E

Problem Solver
Moderator
#5
Their manufacturing process or equipment will not change.
If any of their processes were validated, they will need to revalidate even if the equipment was "merely moved".
would it be considered a "significant change" under the MDD and would need to be notified?
If the devices are being placed on the market under the MDR transitional provisions (MDD certificate valid under certain conditions and limitations), no significant changes are allowed. This is bigger than whether to notify or not. Especially if the NB considered this supplier "critical" (is this officially documented anywhere?).
 

franklymissshankly

Starting to get Involved
#6
If any of their processes were validated, they will need to revalidate even if the equipment was "merely moved".

If the devices are being placed on the market under the MDR transitional provisions (MDD certificate valid under certain conditions and limitations), no significant changes are allowed. This is bigger than whether to notify or not. Especially if the NB considered this supplier "critical" (is this officially documented anywhere?).
Ronen, thanks for the heads up. I don't believe our devices are in the market under MDR transitional provision- we have still not decided if we would like to move to MDR once this CE certification expires. The NB did consider this supplier as "critical". They are mentioned as our "critical subcontractor" who perform manufacturing for us.
 

Ronen E

Problem Solver
Moderator
#7
I don't believe our devices are in the market under MDR transitional provision
They definitely are, if they are still being placed on the market. I'm afraid you don't have a choice since the Date of Application - 26.5.2021 - when the MDD was effectively repealed. Any legacy devices being placed on the EU market after that date under existing MDD certificates are under the MDR transitional provisions.

I am also very certain that your NB needs to know that your Contract Manufacturer (that's not just any "crucial supplier" or "critical subcontractor") is moving to a new site! Regardless of MDD, MDR, "critical" etc.
 

franklymissshankly

Starting to get Involved
#8
They definitely are, if they are still being placed on the market. I'm afraid you don't have a choice since the Date of Application - 26.5.2021 - when the MDD was effectively repealed. Any legacy devices being placed on the EU market after that date under existing MDD certificates are under the MDR transitional provisions.

I am also very certain that your NB needs to know that your Contract Manufacturer (that's not just any "crucial supplier" or "critical subcontractor") is moving to a new site! Regardless of MDD, MDR, "critical" etc.
Very interesting insight, Ronen! Seems like we need to get in touch with the supplier ASAP and get this sorted. Thank you, I really appreciate your help
 
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