This message was posted by a user wishing to remain anonymous
Thank you for your response Ronald.
But as a System/Procedure Pack Producer, providing an EMDN code for the S/PP (not as a device in its own right!) is mandatory on EUDAMED. So I do not see how an EMDN code can be assigned, when the codes are device specific.
Original Message:
Sent: 20-Mar-2024 03:23
From: Ronald Boumans
Subject: EMDN for System/Procedure Pack under MDR Art. 22
It is correct there are no EMDN codes for Article 22 S/PP. The reason for that is, that the individual devices should already be certified in their own right, under their own EMDN code.
If you feel the need for a separte code, you may either have a S/PP that is a device by itself and not under Article 22, or you have a serious labelling issue. Reach out directily if you want to discuss this further.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 19-Mar-2024 11:53
From: Anonymous Member
Subject: EMDN for System/Procedure Pack under MDR Art. 22
This message was posted by a user wishing to remain anonymous
According to MDCG 2018-4 and EUDAMED itselt, an EMDN code is required as a data element to be uploaded onto EUDAMED for System/Procedure Pack (S/PP). However, it does not seem like there are specific EMDN codes for S/PP (European Medical Device Nomenclature (EMDN) (europa.eu)), or a guidance for when the below happens:
"Two devices are packaged together in S/PP, but they have different EMDN codes as an individual device."
How can a suitable EMDN code be assigned?
Thanks