UDI (Unique Device Identification) Requirements for IVD Software

H

HeatherC-S

Hi all

I am currently preparing to self certify some IVD software and am unsure of the UDI situation. As I understand this does not come in to force until 2017, but I thought it best to get this sorted out now. How do most people comply with UDI regulations? I have found a company GS1 that seem quite good - have people had experience using this company? Thanks in advance.
 

L_O_B

Involved In Discussions
Hi Heather,
Since you are posting in the EU forum I assume that you want to market your device on the Union market. Currently there are no UDI-obligations in the EU I am aware of.
There are some UDI-obligation in the upcoming IVDR:
The obligation to assign a UDI to an IVD is set out in article 22(4) and by means of article 90 (c) this obligation applies 1 year after its date of application at the earliest which means about 6 years from entering into force which means at least 6 and a half years from now.
And this is just for high risk products (D). For very low risk products (A) this applies 6 years later which means over 12 years from now.
 

dgrainger

Trusted Information Resource
It depends on the class of your software, the new IVDMDRs will probably come into force next year and then for UDI:

"For class D devices Article 22(4) shall apply one year after the date of application of this
regulation. For class B and class C devices Article 22(4) shall apply three years after the date of application of this regulation. For class A devices Article 22(4) shall apply five years after the date of application of this regulation."

(From June 27 2016 version (subject to change!!!) )
 
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