ISO 13485 Required for CE Mark on Class I product

Mor628

Involved In Discussions
#1
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.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
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).
 

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