Change Circuit Board to CE marked product on CE Marked Medical Device

K

KAMay

Hi,

My company wishes to change a circuit board on their CE Marked Medical Device. They are not in any way changing the fuction of the product, they're basically replacing an off-the-shelf module on one of the circuit boards with one they are making themselves.

Obviously they will test it, with a certified EMC tester and review the impact on risk.

My question is this - we JUST had our audit with SGS at the start of January, can we hold off on informing them of this change until the next audit and keep the product CE marked - if not, will we require a completely new audit of the product or do we just have to send them our updated tech file?

Time is of the essence as we want to complete an order sooner rather than later with the amended circuit board.

Thanks in advance for any advice,
K
 
S

SteveK

Re: Change to CE marked product

Hi K,

If the change is 'significant' - which it looks like, you are required to inform the NB. They will then expect an updated technical file with new data/information etc. I am going through a similar process with a class IIb device. My NB expects an electronic submission of the techical file before we market our particular variation. A fresh audit is not required - this was for the QMS. Hope this helps.

Steve
 
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