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ISO 13485 Required for CE Mark on Class I product
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ISO 13485 Required for CE Mark on Class I product
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ce mark and ce marking, class i medical device, iso 13485 - medical device qms
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  Post Number #1  
Old 7th August 2018, 06:45 AM
Mor628

 
 
Total Posts: 42
Please Help! ISO 13485 Required for CE Mark on Class I product

Hi guys,

We were recently told by our Notified Body, in order to place a CE mark on our Class I product our critical subcontractor (we are the PLM) must have ISO 13485. Can anyone confirm that this is indeed the requirements?

All this while we have understood self-declare to mean that we the legal manufacturer are making a declaration on this medical device, without the involvement of the Notified Body.

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  Post Number #2  
Old 7th August 2018, 07:52 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: ISO 13485 Required for CE Mark on Class I product

Quote:
In Reply to Parent Post by Mor628 View Post

Hi guys,

We were recently told by our Notified Body, in order to place a CE mark on our Class I product our critical subcontractor (we are the PLM) must have ISO 13485. Can anyone confirm that this is indeed the requirements?

All this while we have understood self-declare to mean that we the legal manufacturer are making a declaration on this medical device, without the involvement of the Notified Body.
Regarding the specific question, no , nor ISO 13485 nor any other standard is required for CE marking (see, for example, Use of harmonised standards here: Harmonised Standards - European Commission. What is required is to fulfill the QMS requirements of the CE Marking route (annexes) that you choose to use.

Which route are you using? If your device is a class I device without sterilization or measuring function, you can self declare using only Annex VII (this is detailed in Article 11, which details the conformity assessment routes. In particular for class I devices, it's item 5).
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
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