What is the European UDI implementation timeline?

Frypot

Starting to get Involved
#1
Hi,
I'm having a tough time trying to find an indication of when the UDI for medical devices will become a legal requirement.
I am aware they are likely to be rolled out in risk priority; i.e. Class III first and ending with Class I, but what the proposed scheduling is I can't seem to find.
Anyone got an idea?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#3
This is what GS1 has to say:

UDI update - are you ready for 2017?

In the US the compliance date for Class 3 medical devices was September 2014. This means that if you are supplying product into the US, a condition of sale is that there is a UDI (standardised barcode with ID and batch information) on the product packaging. The compliance dates are staggered over the next few years to support implementation by suppliers.

A similar regulation is expected to take effect in 2017 for EU member states.
http://www.gs1ie.org/Healthcare/Sectors/Medical-Devices/
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

I think that the whole timeline for EC Medical Devices regulation changes is a bit foggy. A massive change (MDD -> MD Regulation) is in the making a long time, and is affected by political clashes of all sorts. 2017 may be one of the estimates for completion, but I wouldn't regard it as too meaningful.

Cheers,
Ronen.
 
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