Can a product option change the product class?

S

SLandry92

Registered
#1
#1
Hi, I'm questioning myself regarding our product.

Our product base model is Class I regarding CE and UKCA, there's no question about that.

My questioning comes from the fact that this specific product can have an add-on that itself is Class Im, since it has a measuring function. This add-on already has CE marking on it, we have the certificates for it.

Do we need to have CE Marking for our entire product as Class Im or could we proceed with our product simply staying Class I with self declaration?

For the add-on in question, it is certified via 2014/31/EU and our product is self declared as 2017/745, so both don't even fall into the same regulation.

I hope you understand my questioning and my reason to ask here is the our Authorized representative told us to ask our notified body and our notified body pulled a UNO switch card and told me it should be our AR that could answer. Hoping someone here can shed some light!
 
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WAQAR-QMS

WAQAR-QMS

Medical Devices Expert
#3
#3
For exact guidance, the post needs alot details of products to check for that.
But on summary note.
there are many options to do that.
You can go with whole product as Im (the best approach for regulatory). as in connection components and devices higher risk/classification is to be considered. it is given in CE regulation.
But if add-on is supplying by some other supplier, you can go with OEM.
If you dont want to involve supplier kind relation, supply add on separately from product.
If you need more guidance, feel free to write
 
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