Procedure for Change of Notified Body (NB)

we have a class ii ( expiring in March13 )and class 111 (expiring july 13 )CE certficates form Notified Body A

we want to change and go to a new Notified Body B

if the new notified body B carries out audit in March 13 and issues certifiates for both class 11 and class 111 is it ok even though the class 111 certificate form notified body A is still valid ? if the answer is no what is the correct procedure to follow . do i have to keep the old notfied body A informed that i am not getting re certfied by them ?

Thanks

michelle

Re: Change of Notified Body

No, it is not OK
Yes. You will have to inform NB A, and tell a plan by when you want your CE withdrawn.
A product cannot be CE marked with two NB.
Your NB B will also check to ensure that your product is not notified by an other NB.
If you plan it with both NB, your break time can be minimized.

CARE for your inventories. Your NB A will ask you lots of questions about your last lot / last batch details that you CE mark with NB A number.

Re: Change of Notified Body

Michelle,

Another point to bear in mind is that certification transfer process involves not only re certification audit but also Design Dossier review process. When you decide to transfer the CE certificate, it might take at least 2-3 month to the NB B to review your Design Dossier, depending on the complexity of the product. Moreover, if during the Design Dossier review NB B considered the product did not meet the essential requirements it would not transfer certification until such time it was satisfied conformity with the medical device directive was achieved.

The above two posters are both correct. Also, you can look at the NBOG BPG document, "Change of Notified Body" 2006-1. If the link below doesn't work, you can just google it and it should come up either on its own or via NBOG's webpage.

Here's a link: http ://www .nbog. eu/resources/NBOG_BPG_2006_1.pdf - DEAD 404 LINK UNLINKED BUT THE FILE IS ATTACHED TO THIS POST

Good luck!

Re: Change of Notified Body

Hi Yana,
We have faced exactly the situation you mentioned and the continuity of the CE certificate was cut.
now we're looking for new notified body that can audit our facility in Israel (Medical device, Non-active, class 1s, 2a, 2b, 3).
Where can i find a list of notified bodies that are working in Israel?
who are you familiar with?
Thanks,
Noa.

Hi Yana,
Please resend your private message - one digit is missing.
thanks,
Noa.

Dear collegues,
we found ourselves in a tricky situation. We are about to have a surveillance audit (9001, 13485, CMDCAS 13485) in may 2015, but our norified body - SGS told us they will no have any availible auditors at least by the end of 2015.

Because it is end of february, we have 3 months to decide what to do.
I would like to ask for advice, what do you think is the most apppropriate strategy.

What happen when SGS will not make the surveillance audit?
Can we have a different NB for QMS (9001/13485) and for EC certificate?
We plan to make some changes in our products that will require off-site technical review and amendment of EC certificates.
Is is possible to make changes in EC certificates without having surveilance audit?

Thanks!

I assume that you have a contract with SGS for auditing purposes which indicates the frequency of the audit. So if it says annually, they are at fault and it should not affect your certification. If your current certification extends beyond when they will in practice carry out the audit (i.e. the end of 2015), it should not therefore matter. I had a similar issue with our (different) NB, in fact I had to remind them that our audit was due. They ended up conducting the audit 4 months late and fortunately our (ISO 9001/13485 & CE) certification was not about to expire. There was no issue from their standpoint with the certification. If you plan to modify the certification e.g. submit a new TF to add a new product type or similar, so long as the new TF (or an updated/modified TF) is accepted, I believe they will be obliged to issue an updated certificate as necessary (before the actual audit). This is just all my opinion though. You need to talk to them directly to find out if this is indeed OK. In the end to sort out a new NB may take longer than the timescale that is currently the issue.

Steve

Thank you Steve!

Yes we had recertification audit last year.
It is written on the certificate that it remains valid subject to satisfactory surveillance audits. I was affraid that they will have to invalidate them.
thanks for advice !

Dear All,
Sorry for re-activating this thread, but I think my request hitting exactly this topic.
Does anyone want to share his/her experience of switching the NB?
Currently we were successfully re-certified, but it was a long and hard fight...
Our Management is thinking about to change the NB in the hope of smother communication and more consistently Audits as we had in the past (last 3 years).
So, it would be very nice to read/hear some experience how the process of changing the NB is in fact. I already read the NBOG or ZLG documents…these are just theoretical papers…I do not believe this process is so “easy” as they describe it.

What are the hidden obstacles?
How was the cooperation of the separated NB?
Timeframe gapless?
Approx. costs?

Thank you!