Changing PCB Assembler and impact on QMS and MDD CE Certificate

#1
We are the manufacturers of a Class IIa medical device that is CE marked under the MDD regime. All assembly activities are outsourced to a contract manufacturer to whom we provide all the materials as per BoM. PCB assembly has been called out as a separate outsourced activity given to a different vendor. We want to change the PCB assembly vendor to a different party that will continue to manufacture the PCBs as per the same design specifications as the previous vendor. Will this be considered as a significant change and what level of revalidation does it call for?
 
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yodon

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#2
Will this be considered as a significant change
Yes, I would certainly expect so!

what level of revalidation does it call for?
That's really up to you to decide and be able to defend. Since you're moving to a new vendor, there's all new equipment, new operators, new means to do any quality checks, etc. I would think all the processes (whose outputs aren't 100% verified) would need to be validated.
 

Junn1992

Quite Involved in Discussions
#3
Jus to add on to consider managing outsourced processes according to the MDR, so quality agreements would probably have to be relooked at.
 
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