UDI Database and EUDAMED - Will there be two separate databases?

monoj mon

Quite Involved in Discussions
#1
Hi all,

Will there be two separate databases, UDI-database and EUDAMED under MDR! This question came to my mind after going through the Article 28 and 29 of MDR 2017/745. Or the UDI-database will be an integral part of the EUDAMED!
 
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shimonv

Trusted Information Resource
#2
From the looks of it, it's going to be two separated databases, one for each region. The UDI number will remain unique globally, but each region will maintain information about the approved/cleared devices in its area.

Shimon
 

L_O_B

Involved In Discussions
#3
Hi monoj mon,

Just a few articles further (33), there would have been your answer:
Eudamed consists of 7 electronic systems
(a) the electronic system for registration of devices referred to in Article 29(4);
(b) the UDI-database referred to in Article 28;
(c) the electronic system on registration of economic operators referred to in Article 30;
(d) the electronic system on notified bodies and on certificates referred to in Article 57;
(e) the electronic system on clinical investigations referred to in Article 73;
(f) the electronic system on vigilance and post-market surveillance referred to in Article 92;
(g) the electronic system on market surveillance referred to in Article 100.

So the UDI-database is part of Eudamed
But if your real question was, if there were different systems for UDI and device registration, the answer is yes.
 
#5
Thanks Shimon and L_O_B, I somehow overlooked the Article 33.
EUDAMED is one large database with multiple modules. I have some presentations on EUDMAED available on youtube, just search for Eudamed or my name (Richard Houlihan) and you will find them. For info, I used to manage the IT team creating EUDAMED.
 
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