What is the difference between CE marking and CE certificate

[Fatima444-4]

Good evening everyone

iam new to medical device regulations

i just worked on 2 projects related to class 2 medical devices.

i need to your kind help to tell me the difference between CE certificate and CE marking ?

Thanking you all

 

[Coury Ferguson]

I was reviewing another thread similar to this one, but was a electrical switch (http://elsmar.com/Forums/showthread.php?t=30103). But I would guess that maybe the same applies. Depends on size of the product, would the marking be detrimental to the function or use of the product?

If the device is to small to properly identify it with the CE mark, then the certificate should be sufficient.

I am not a medical device specialist so I could be way off base on my comment.

Maybe there is some medical device specialist here that would provide better guidance.

 

[Ronen E]

Good evening everyone

iam new to medical device regulations

i just worked on 2 projects related to class 2 medical devices.

i need to your kind help to tell me the difference between CE certificate and CE marking ?

Thanking you all

Hi,

For medical devices:

CE marking is the actual marking. It is mandatory in order to place a medical device on the EU market, but it's only allowed once all the applicable requirements* have been met.

An EC certificate (not CE certificate) is one of the requirements that must be met before CE marking a class 2a or 2b device. It's issued by a Notified body upon application (and audit).

With regards to the actual marking, the packaging and labeling are required to bear the CE Mark and in some specified circumstances it suffices, ie the device is exempted from being directly marked.

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*) A medical device may also be subject to EU directives other than the Medical Device Directive (MDD). Some of these directives include requirements that must be me before CE marking. The CE Mark can be applied only after all applicable requirements in those directive's have been met.

 

[muzammil21ad]

To apply CE mark on your product you should have CE certificate


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[pkost]

To apply CE mark on your product you should have CE certificate


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As pointed out above, it is an EC certificate that is required (not CE). EC certificates are not required (or possible) for Class I products as they are self declared and EC certificates are issued by a notified body.