NB approval - Basic question about Notified Bodies and their role

#1
Hi everyone,
I would like to ask a basic question about Notified Bodies and their role.

If I already have a CE certificate issued from a Notified Body, after notifying them about a new product that I want to introduce in the EU market (submitting Technical Files, formulating Declaration of Conformity including it etc...) do I need to wait for their approval to release it, or can I already release that product in the market?
Does this depends on the class of the medical device? (I am interested in class IIa and IIb)
Of course the product falls under the scope of the CE certificate (it is not in a new product category, that is not covered by the CE certificate).

Also, a second question I have about the CE number.
If I have a valid certificate (until September 2021), but the organization cannot be my NB anymore (although the NB is still active), can I still use their CE number on my products until the certificate expires?
Or is the certificate void?

Thanks,
Mark
 
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Sicco

Starting to get Involved
#2
Hi Mark,
1) yes you have to wait until NB will approve your new MD before its release.
2) I do not understand - what do you mean that NB cannot be your NB anymore? Do you mean because of MDD->MDR?
If your NB cancelled your certificate, they should announce it to you until this, your current certificate should stay valid until its expiration.
 

MedicalDevice

Involved In Discussions
#3
2) I do not understand - what do you mean that NB cannot be your NB anymore? Do you mean because of MDD->MDR?
If your NB cancelled your certificate, they should announce it to you until this, your current certificate should stay valid until its expiration.
I think I know what he means. Several Certification companies announced to their clients that they cannot be their NB anymore.
Example:
1579786268041.png
 

shimonv

Trusted Information Resource
#4
Hi Mark,
Your first question implies that you have a living relationship with a notified body and that they are reviewing your technical file.
Your second question implies that your relationship with the notified body is rescinded.

You need to be more clear if you want to get a good answer.

Cheers,
Shimon
 
#5
1) yes you have to wait until NB will approve your new MD before its release.
Your first question implies that you have a living relationship with a notified body and that they are reviewing your technical file.
This is logical. Yet, could you specify where this part is stated in the MDD?
I am asking because the "Notified Body" is supposed to get 'notified' (as the word defines) by the manufacturer, about product changes or new product introduction.
The manufacturer can have a completed technical file or declaration of conformity like Mark said but the NB can still delay its approval for a year or even more. Does the manufacturer have to wait that long? Because to my understanding the NB needs to get notified by the manufacturer (and is being checked by the EC).
-Mike
 

Sicco

Starting to get Involved
#6
Yet, could you specify where this part is stated in the MDD?
According to Article 17 you have to affix CE mark on the medical device which you want to release for EU market. For affixing of CE mark on the device you have to fulfil requirements of conformity assessment according to appropriate Annex of MDD which could be used for your device. For higher risk class devices IIa, IIb and III in this process NB have to be involved -> you could affix CE mark based on EC Certificate which your NB issue to you after NB finalised evaluation of your medical device.
 

twanmul

Involved In Discussions
#7
I think others have answered for the first question, so won't bother to add.
For question 2, it might be worth speaking to your NB, especially if you're looking to take advantage of transitional provisions listed in Article 120 (110 of IVDR) and continue to manufacture and make available established devices under your existing certificate.
 

Belen Sanchez

Starting to get Involved
#8
Hi, unfortunately, our company is one of these cases: last year our Notified Body informed us about breaking the Agreement with us. From this day, I'm searching for a new NB, but unsuccessful. I've thought about a B plan, but I'm not sure. Do you know if a company in UE can still selling MD although the CE certificate is expired? Provided as the product has been manufactured under CE certificate before expiration.

For example, if our CE certificate expires on the 25th January 2020, could the company sell products on the 26th of January, because they have been manufactured before the 25th of January (under a valid CE certificate), do you know if it is acceptable?
 

Ronen E

Problem Solver
Staff member
Moderator
#9
For example, if our CE certificate expires on the 25th January 2020, could the company sell products on the 26th of January, because they have been manufactured before the 25th of January (under a valid CE certificate), do you know if it is acceptable?
You are not allowed to place devices on the market (= make the first sale within the EU) without a valid EC certificate, regardless of when these units were manufactured.
 

MedicalDevice

Involved In Discussions
#10
You are not allowed to place devices on the market (= make the first sale within the EU) without a valid EC certificate, regardless of when these units were manufactured.
So, even without a NB for a whole year they were still allowed to sell products until Jan 25th 2020 (since the expiration date of the certificate was this one)?
 
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