M
Mor628
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.
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.