Changing PCB Assembler and impact on QMS and MDD CE Certificate

SumedhK

Registered
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?
 

yodon

Leader
Super Moderator
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
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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