Is CE IVD marking required on CoA and CoC?

sreenu927

Quite Involved in Discussions
#1
Hi All,

Is it required to have CE marking and IVD symbol for an IVD's Certificate of Analysis (CoA) and Certificate of Compliance (CoC)??

Regards
Sreenu
 
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bio_subbu

Super Moderator
#2
Re: Is CE IVD marking required on CoA??

Hi All,

Is it required to have CE marking and IVD symbol for an IVD's Certificate of Analysis (CoA) and Certificate of Compliance (CoC)??

Regards
Sreenu
Hi Sreenu

CE marking and IVD symbols can use in product labels and other marketing promotional materials, it’s not required for COA & COC.
 

sreenu927

Quite Involved in Discussions
#3
Hi Subbu,

Thank you very much for the information.

however, based on afew customers request, we would like to include both CE Marking and IVD symbol in Certificate of Analysis and Certificate of Compliance.

How abt the Warranty cards issued by the manufacturer and User Bulletin (this is just a bulletin based on Waste Electrical/Electronic equipment, EC Directive)?? Do we need to have CE and IVD on them??

Any more answers plz!!

Regards
Sreenu
 
M

Medsearch

#4
Hi All,

Is it required to have CE marking and IVD symbol for an IVD's Certificate of Analysis (CoA) and Certificate of Compliance (CoC)??

Regards
Sreenu
What is the difference between certificate of analysis (CoA) and certificate of compliance (CoC)??
 

bio_subbu

Super Moderator
#5
What is the difference between certificate of analysis (CoA) and certificate of compliance (CoC)??

Certificate of Analysis (COA) is a record of quality control testing performed for the product/ material which indicates whether the product or material conforms or not.

The Certificate of Compliance (COC) is a record that everything which was performed as a part of manufacturing that material or product has been verified and was found to be in compliance to all its written procedures (batch instructions, written procedures).

Regards
S. Subramaniam
 
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