Consequences of letting the CE Certificate Expire

[somashekar]

I realize that this thread is long dead, but I thought I'd try my luck anyways before creating a new one.

My question is:
Once a business has lost its CE mark certification on a particular product, can that business continue to ship that CE labeled product to countries that DO NOT require the CE mark? (I'm refering to newly manufactured product after the CE mark expiration, not inventory previously manufactered)

In doing a little bit of reasearch on my own, I'm thinking that for shipping to the US specifically, the FDA would consider this "misbranded" as the CE mark is now false, even through in the US we don't require it. The FDA's website states "misbranded product" includes the case when "Its labeling is false or misleading in any particular"

The implication of this question comes down to whether the current packaging and labels for that product need to be reworked to remove the CE mark to allow for shipment even to countries that don't require the CE mark. Thoughts?

Thanks for your time!

Welcome here sjqlty ~~~
Look, the CE mark is not your's. You have the authorization to CE mark after a series of activities are completed, and you make out a declaration of conformity.
I assume that you are also talking of this case with a notified body associated, as you say "Lost its CE mark"
You simply do not use of the CE mark on the product, once you lose it. This is your agreement with the notified body. The question here is not about EU countries or other regions.

Once a business has lost its CE mark certification on a particular product, can that business continue to ship that CE labeled product to countries that DO NOT require the CE mark? (I'm refering to newly manufactured product after the CE mark expiration, not inventory previously manufactered)

My answer is NO. You cannot

 

[sjqlty]

Welcome here sjqlty ~~~
Look, the CE mark is not your's. You have the authorization to CE mark after a series of activities are completed, and you make out a declaration of conformity.
I assume that you are also talking of this case with a notified body associated, as you say "Lost its CE mark"
You simply do not use of the CE mark on the product, once you lose it. This is your agreement with the notified body. The question here is not about EU countries or other regions.

My answer is NO. You cannot

Thanks Somashekar-
Maybe I dind't word it properly. I'm refering to the case when a the notified body states to a business that a product's CE mark is no longer valid. Based on that occurring, am I to understand that you believe that a company cannont continue to ship CE marked product even to the US? (based on your answer No above)

Can you provide me with your rationale?

 

[somashekar]

Thanks Somashekar-
Maybe I dind't word it properly. I'm refering to the case when a the notified body states to a business that a product's CE mark is no longer valid. Based on that occurring, am I to understand that you believe that a company cannont continue to ship CE marked product even to the US? (based on your answer No above)

Can you provide me with your rationale?

You have worded it properly. May be I used the word 'cannot' which makes you to ask clarification. Well, My answer remains say. My answer is NO. You must not.

 

[sjqlty]

You have worded it properly. May be I used the word 'cannot' which makes you to ask clarification. Well, My answer remains say. My answer is NO. You must not.

Thanks-
Can you explain why not? What regulation would this be violating?

 

[somashekar]

Thanks-
Can you explain why not? What regulation would this be violating?

When you get some time, read the agreement that you have signed with your notified body about the CE mark process.
Also read the letter that your notified body would have sent to you to say your obligation about the no CE mark use once withdrawn.

 

[MIREGMGR]

...for shipping to the US specifically, the FDA would consider this "misbranded" as the CE mark is now false, even through in the US we don't require it. The FDA's website states "misbranded product" includes the case when "Its labeling is false or misleading in any particular"

While your analysis is rigorous and on point in regard to the published guidance, I think in practice US FDA would not go there. Their deliberate ignoring of all aspects of EU regulation would override their rightful declared focus on non-misleading labeling.

I'm not aware of any instance in which FDA has reviewed the existence, let alone expiration status, of a CE certificate. Even for the VARS Program, for which ISO 13485 certification is a core issue, CE certificates are not reviewed.

A few elements of CDRH are interested in harmonization, but other parts... particularly including ODE, who have responsibility for the labeling guidances... prefer to pretend that the issue doesn't exist.