Does MDD Cert extend to September if you lodge the application?

Clueless One

Climbing coporate ladders...by doing nothing.
I'm curious that if the application by NB passes 26th, May 2024.

2023/607 states that you need to have written agreement between NB and the Mfg before september, buy what happens to the MDD Cert between that period?

Does it magically becomes invalid and became valid again once the agreement is signed?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Your nb will provide a letter for article 120 of MDR. You need a contract signed and the post market surveillance from a few years ago done
 

Clueless One

Climbing coporate ladders...by doing nothing.
Your nb will provide a letter for article 120 of MDR. You need a contract signed and the post market surveillance from a few years ago done

The QMS part is quite clearly stated in 2023/607 so I don't have any doubt regarding that part.

What I'm confused is that some CA don't recognize the formal application part.

2023/607 states that written agreement must be obtained before September, but CA states that regardless of status of formal application, the MDD Certification will not be recognized and rendered voided until written agreement is obtained.

Shouldn't manufacturer's declaration and formal application status by NB should suffice to be available until september?
The Article 120 paragraph 2 states that Valid CE certificate that is not withdrawn are valid until the date sat in 3a. And to my knowledge, CE certificate should be remain valid until September when the formal application is already lodged.
 
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Billy Milly

Quite Involved in Discussions
I understood you did not yet file an application, thank you for clarifiying.
CA is probably expecting the extension letter (prepared by NB) to cover the period before the agreement is signed. Their wording is wrong in any case, either requiring a contract or calling the extension letter a contract.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
The language is odd. Since the MDD is gone I think the correct term is “compliant with Article 120 of the MDR?”

Saying compliant to MDD isn’t a thing. I think
 

Clueless One

Climbing coporate ladders...by doing nothing.
The language is odd. Since the MDD is gone I think the correct term is “compliant with Article 120 of the MDR?”

Saying compliant to MDD isn’t a thing. I think

Again, thank you for your input.

It seems that the issue both NB and CA is taking is the word "extension".

Our contracted NB was saying that they cannot officially say that the MDD certificate is "extended" because they cannot issue MDD Certification anymore.

And CA is taking a issue because the word "extension" means that NB has reviewed and renewed the MDD certificate which is simply not possible at this moment.

I send them our declaration letter with a word "Valid" instead of extension. Hope this works because I'm certainly not on board of doing registration process again.
 
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