Hello Anon.
From your description, you are assembling a kit or system as described in MDD Article 12 or MDR Article 22, so you should follow the appropriate instructions for such kits.
While MDD Article 12 is largely silent on the question you raise, MDR Article 22 provides more detail, specifically in paragraph 5 of Article 22, in which it states:
"Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I." In this context, for 'manufacturer' in Section 23 of Annex 1, read 'assembler'.
In order for the end user to know what is in the kit, and to meet the MDR labeling requirements, I would suggest that the outer packaging of the kit identifies what it contains, which may usefully include the CE marks, with NB ref nos, of the individual devices within the kit.
Hope this helps.
------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 08-Feb-2021 10:46
From: Anonymous Member
Subject: OEM Supplier CE marks
This message was posted by a user wishing to remain anonymous
Is there any obligation to display OEM Supplier's CE marks when co-packaged with our medical device kit packaging?
We have a medical device that is sold in multiple configurations with different OEM Supplier accessories available that carry their own NB CE mark. The kit contains devices and accessories of our own that carry both self certified and NB CE marks. My gut says we need not place the OEM CE marks on our labeling since we do not own those marks.