moounir
Involved In Discussions
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?
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?