MDD Technical File CE Mark - Addition of a Device to our Current CE Marked Family

S

spectra123

Hello,

We have a CE marked family of devices with a technical file which was reviewed by our notified body about 3 months back. We plan to market a third version of our device. The device is exactly the same as our CE marked device, but will have a scaled down version of the software and there will be no change in its intended use. We plan to update our technical file and our risk management documents. Should we inform our notified body before we market it or wait for our surveillance audit to do so?

Thanks for your help.

Spectra123
 
G

GPjeri

I don't know what class your product is but our NB provided the following to us in regard to reporting changes:

From the NB perspective: You do not need to report changes to the NB for any self declared products. The NB only needs to be informed regarding significant changes for products on the NB CE certificate.

From the UL Medical Management System perspective: Significant changes in accordance with 00-MB-C0032, section 4.2.3, would need to be reported, if the product is within the scope of the ISO 13485 and/or CMDCAS certificates. For example, if you wish to expand the scope to include a new category of products, or if there are significant changes to the manufacturing techniques/processes for those products, or if you outsourced a manufacturing process that was previously performed in house.


So, check out the short list of changes in 4.2.3, by the description you gave it sounds like it's not reportable, but expect the changes to be reviewed in your tech file upon the next audit.
 
Y

yana prus

well, it's pretty much depends on the class of your device - if is class III, such a change might be reportable. If your device is class IIa or IIb, the decision if to to report or not depends on the annex of the directive you are operating on - under annex II, for the engineering changes, you will have to report only for the significant changes. If you are operating under annex V, the answer would be different. You can always contact your NB to check with them if such a change is reportable.
 
somashekar

somashekar

Leader
Admin
We plan to update our technical file and our risk management documents.
Click to expand...
Sorry ... This must be already in place if the new version is ready.
Should we inform our notified body before we market it or wait for our surveillance audit to do so?
Click to expand...
Is your CE with the full quality assurance per MDD Annex II ?
If so, Inform NB, share the updated technical file and your risk management documents, draft DOC, and ask them if you can mark CE. On review, the NB may nod and include this as scope in the next MDD assessment OR, ask for a MDD assessment ?
So the solution is INFORM NB.
 
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