CE Product Registration Bar Codes for each Product - Anyone?

M

manon1474

#1
Hi.

I am new to the CE IVD process so I would really appreciate some help with maybe totally stupid questions.

We have just received CE IVD certification for our reagents EDMA codes 13 07 01 08 00, 13 07 01 90 00. Now a client asked for "CE registration bar codes" for each of our products and our CE conformity certificate is a general one no bar codes there...If we have the same manufacturing technology for the whole line of our products do we need to register them one by one and get specific bar codes for each products? Who do we register them with? I contacted our notifying body but they didn't know about "CE bar codes"... Please Help!

Thanks.
 
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somashekar

Staff member
Super Moderator
#2
Hi.

I am new to the CE IVD process so I would really appreciate some help with maybe totally stupid questions.

We have just received CE IVD certification for our reagents EDMA codes 13 07 01 08 00, 13 07 01 90 00. Now a client asked for "CE registration bar codes" for each of our products and our CE conformity certificate is a general one no bar codes there...If we have the same manufacturing technology for the whole line of our products do we need to register them one by one and get specific bar codes for each products? Who do we register them with? I contacted our notifying body but they didn't know about "CE bar codes"... Please Help!

Thanks.
Are you refering to some unique globally accepted barcode for your products ...
I am not aware of any CE bar code, but you can register and generate and barcode your products in your own established system with the GS1, perhaps using the EAN13 code.
Look into GS1 in your country for this.
 

bio_subbu

Super Moderator
#3
Hi.

I am new to the CE IVD process so I would really appreciate some help with maybe totally stupid questions.

We have just received CE IVD certification for our reagents EDMA codes 13 07 01 08 00, 13 07 01 90 00. Now a client asked for "CE registration bar codes" for each of our products and our CE conformity certificate is a general one no bar codes there...If we have the same manufacturing technology for the whole line of our products do we need to register them one by one and get specific bar codes for each products? Who do we register them with? I contacted our notifying body but they didn't know about "CE bar codes"... Please Help!

Thanks.
Refer this attached “EUCOMED position paper about bar coding for medical devices” which published on Aug 1st, 2007

Thanks and Regards
S. Subramaniam
 

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