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Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745)

moounir

Involved In Discussions
#1
Hi everyone,

I got an interesting question today and I wanted to ask your opinion. With the MDD we were used to have the "Generic Device Groups" and mainly GMDN Agency was the way to use it.

On the new MDR 2017/745 paragraph 45 (Beginning of the regulation) there is this text:
(45)
To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders.
So I wanted to ask you, if the EU is planning to create a free of charge nomenclature which will replace GMDN?
 
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Marcelo

Inactive Registered Visitor
#2
Hi everyone,

I got an interesting question today and I wanted to ask your opinion. With the MDD we were used to have the "Generic Device Groups" and mainly GMDN Agency was the way to use it.

On the new MDR 2017/745 paragraph 45 (Beginning of the regulation) there is this text:


So I wanted to ask you, if the EU is planning to create a free of charge nomenclature which will replace GMDN?

It seems they will. document MDCG 2018-2 Future EU medical device nomenclature Description of requirements mentions the expectations, and at least once it mentions "future design". However, it is not clear (at least to me) how this is gonna get accomplished. One way would be to use the nomenclature WHO is creating.
 

moounir

Involved In Discussions
#3
Thanks Marcelo,

I just read it and there are still an open question.
Will this replace GMDN?

The MDR is still talking about "Generic Device Groups" and I don't know if this medical device nomenclature is not something different (Specific to EUDAMED).

The confusion is the fact that they are asking to have this medical device nomenclature to facilitate EUDAMED but on the Conformity assessment paragraph they are mentioning "Generic Device Groups" for selection of devices.
 

Marcelo

Inactive Registered Visitor
#4
Thanks Marcelo,

I just read it and there are still an open question.
Will this replace GMDN?

The MDR is still talking about "Generic Device Groups" and I don't know if this medical device nomenclature is not something different (Specific to EUDAMED).

The confusion is the fact that they are asking to have this medical device nomenclature to facilitate EUDAMED but on the Conformity assessment paragraph they are mentioning "Generic Device Groups" for selection of devices.
not sure it will replace GMDN, probably for EU only.

Not sure what us the problem with "Generic Device Groups". The solution is that the new system use the same terminology. For example,e an initial part of this is already implemented in
"COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council".
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Not sure if this is relevant at this time, but I recently became aware of this IAF Informative Document 13 - IAF Medical Device Nomenclature (IAF MDN) Including Medical Device Risk Classifications .
to access the document, just click on the image below.

IAF ID 13.JPG
 

WAQAR-QMS

Starting to get Involved
#8
Hi everyone,

I believe so, that they are going to do that, because of intent providing guidance and supporting documents free of charge as from their website.
So, we do hope it got real :)
 
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