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EU CE marking for Medical Device Class I

#1
hi all,
we are new startup company for scar healing products (silicone gel padding), we checked it's belong to Class 1 MDR, we are very confuse what document do we need to prepare.
is that we can self-declaration for ISO13485, we own the IP for our product , but manufacturer is China factory. so do we also need to have QMS?
 
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renenatasha

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#2
hi all,
we are new startup company for scar healing products (silicone gel padding), we checked it's belong to Class 1 MDR, we are very confuse what document do we need to prepare.
is that we can self-declaration for ISO13485, we own the IP for our product , but manufacturer is China factory. so do we also need to have QMS?
HT, did you read thru Annex VIII @ classification?
Which rule have you shortlisted?
Does the gel pad contains medicinal substance?

Once you've classified the device correctly, select the conformity assessment path which will lead you to more details.

In all cases, you'll need Annex I - III.
 
#3
HT, did you read thru Annex VIII @ classification?
Which rule have you shortlisted?
Does the gel pad contains medicinal substance?

Once you've classified the device correctly, select the conformity assessment path which will lead you to more details.

In all cases, you'll need Annex I - III.

Hi Renenatasha,
thanks for your comments, we checked it's class I, and our gel pad don't contain any medicinal substance.
 
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