Determining a device category according to the MDR

Steve_in_MT

Starting to get Involved
#1
Not talking device class here (Class I, IIa, etc.) but the device category, such as MD 0101 ("Non-active devices for anesthesia, emergency and intensive care") that determines what a Notified Body can and can't audit.

How is this determined for a device? Clearly many devices can fit into a number of different categories. When going to the MDR, if I wanted to use a different MDR category than what the device is under for the MDD, can that be done and, if so, how?
 
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Raisin picker

Involved In Discussions
#2
Have you consulted MDCG 2019-14?
Section 3:
Usually, at the application review stage (as defined in section 4.3 of Annex VII MDR), notified bodies will verify the assignment of codes provided by the manufacturer or will assign these codes to the devices themselves. ... The final assignment is made by the NB.
MDA/MDN code:
Exactly 1 code per device.
The codes should be selected according to their hierarchical order in Regulation 2017/2185. If more than 1 MDA/ MDN code is applicable, the one that is highest in the list should be selected.
Section 3.1:
MDA / MDN-codes reflect the design and intended purpose of the device ...
So, it's up to you to argue the code, but it's up to the NB to make the final decision. If several codes apply, the one with the lowest number has to be used. It doesn not matter (much) what scope was used under MDD, they do not all translate 1:1.
 

Steve_in_MT

Starting to get Involved
#3
Thank you very much! That gives me hope that a different category possibly could be used (especially since it has a lower number (which I'm assuming is what is meant by "highest in the list") than what had been assigned.
 
#4
Hi everyone, this is my first post here. Not sure if my query is the same device category question but similar. I am new to the area and currently trying to register EO in EUDAMED. In the mandate summary I need to fill in the generic device group using EMDN codes. AR suggested using EMDN codes which is currently a list of CND.

I am quite confused when assigning CND code for our products. It seems some product matches several CND codes e.g. one product name in our certificate covers 2-3 variants (each have a specific CND code, e.g. Axxxx01, Axxxx02 all under the same product); some procedure pack I cannot match with anything in the list; some support/ accessory device seems to match 2 different code under complete different category starting with different letters (e.g. C**, D****).

My thought is for the 1st type, if one product covers 2 level4 CND codes, maybe use level2 or level3 code which then covers all the level4 variants. For procedure pack maybe use the main componet in the pack to match the CND code? and for support/accessory device seems to match/fit the description of 2-3 CND codes, I really cannot figure out which one. And I am not sure once uploaded and registered in EUDAMED, can I still amend those code later on if I didnt chose the right one? Any corrections? Thoughts? THX
 
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