Changing a UK Notified Body - Anyone with any experience?

Dave-h

Involved In Discussions
#1
I wonder if anyone within the UK, has any experience of changing their notified body, or knows of anyone that has?

This is not a step that I would take lightly, as our current notified body number appears alongside all of our CE marks (product and literature), so making all of those changes would not be quick, easy or cheap.

There is also the question of the product that is out in the market with the notified body number marked on it.

I would welcome any feedback from anyone that has gone through the process, or has tried to…..

Many thanks,


Dave :cool:
 
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W

wrodnigg

#2
Hello Dave-h,

you can change your notified body, if you want. One important question is, which kind of contract you have with your NB (5-year contract?).

It is quite easy to change the NB in case of re-certification. But you can also change the NB at any time you wish.

You have to agree with both NBs, until which batch you will use the old CE identification number, and from which batch you will use the CE identification of the new NB (The CE mark is important for placing products on the market the first time, so there is no need to rack your brain on products already on the market, when you made a controlled change of your NB).

And there are some other regulatory aspects, which you have to consider...
 
A

Aaron Lupo

#3
Dave-h said:
I wonder if anyone within the UK, has any experience of changing their notified body, or knows of anyone that has?

This is not a step that I would take lightly, as our current notified body number appears alongside all of our CE marks (product and literature), so making all of those changes would not be quick, easy or cheap.

There is also the question of the product that is out in the market with the notified body number marked on it.

I would welcome any feedback from anyone that has gone through the process, or has tried to…..

Many thanks,


Dave :cool:
I have and it was a nightmare, well at least from the bitter group we switched from. They made our lives a living heck, it can be done but just be careful that if any of your major customers use that notified body as there maybe trouble. For exmple the NB we switched from tried to hold one of our Major Customers Cert. hostage until we agreed to letthem in to audit us at our expense, which we didn't. Any way if you want all the messy details e-mail me.
 
C

celeo

#4
change NB

You can change NB anytime with written notice of intent. CE mark certificate is valid for 5 years with annual surveillance. A 'rollover' audit is usually no where near the cost of a 1st time EC cert (MDD/AIMD) audit. Obviously a new EC cert is issued by new NB who has a different ID number to previous NB. This means a lot of labels and labelling (IFU, sales brochure etc) need to be changed. The period of time for transition of these various labels must be documented. Typically less than 3 months. Legally the old Declaration of Conformity needs to state end of marking with old NB number. A new DoC must specify start date / batch / lot or other traceable beginning of new NB number CE marking. A multi-device manufacturer usually prefers to stick with the devil they know, rather than go through the time and expense of changing Notified Bodies. In the Directive it states a manufacturer may only have one NB at a time.
 
M

morinmorice

#5
Hi,
I am relatively new to the forum, and I am not quite sure how to use it yet. I came across your answer about Changing a Notified Body and the mention that there are Regulatory aspects to be considered. I am evaluating this for my company right now and other than having to change labeling and registrations in the European countries where we are marketing, I was wondering if there was anything else? We are marketing a Class III cardio device in all the European Countries and we are not satisfied with our current NB. Quality is evaluating NBs but as Regulatory, I need to see what the impacts are.
Thank you for your help,
Seasons Greetings,

morinmorice


Hello Dave-h,

you can change your notified body, if you want. One important question is, which kind of contract you have with your NB (5-year contract?).

It is quite easy to change the NB in case of re-certification. But you can also change the NB at any time you wish.

You have to agree with both NBs, until which batch you will use the old CE identification number, and from which batch you will use the CE identification of the new NB (The CE mark is important for placing products on the market the first time, so there is no need to rack your brain on products already on the market, when you made a controlled change of your NB).

And there are some other regulatory aspects, which you have to consider...
 
R

Roland Cooke

#6
I'm sorry (Aaron) had a bad experience changing Notified Bodies in the past, hopefully it wasn't with us! :D

Notified Body transfers are made for a variety of reasons. In my experience this is usually because of merger/acquisition (i.e. they want to retain only a single NB), or because the company is unhappy with one or more aspects of the service.

Price can be a factor, companies may shop around from time to time - but in my experience price is rarely a key driver. It is service that most companies are looking for, and if that dips, companies may well seek to change. Again, in my experience, most companies are fairly forgiving about the occasional screw-up, it is the effectiveness of the subsequent corrective action that makes or breaks it.

(In addition to NB -> NB transfers, there are occasionally "transfers" where the existing registrar can't provide service for Europe and/or Canada. These can be more involved, and would perhaps require a different thread to discuss).


Notified Bodies such as mine handle transfers all the time. We will go out of our way to make this process as smooth as possible.
Why?
It's a small world, if we act badly it will come back to haunt us. Conversely, if we do a good job, that will pay dividends in the future, for the same reason.
If the transfer is inevitable, let's just get on with it. Finally, because it's the professional thing to do.

Having made the decision to change NBs, the effort on the manufacturer's side is to coordinate change of labelling, and the rest of the things that need to take place.

First find out all you can about the transfer process from your new NB. What do they require and when? Will they require an audit before the transfer?

I think people tend to panic unnecessarily about label changes. Certainly it can be complicated and expensive, but both of these concerns can be heavily mitigated.

You should certainly ensure that your document control, traceability and product inspection systems are robust enough to handle the change-over. If this is a concern, throw some resource at it.

Product made under the previous certificate is fine, no need to change anything. You should note the last batch(es) made under the previous certificate.

Product made under the new certificate can continue to be labelled with the previous NB's mark. The permission must come from the previous NB - it is their mark. This permission is routinely granted, usually with a deadline.

Product made under the new certificate should carry the new NB number as soon as practically/economically possible. This needs to be agreed with the new NB.
From my perspective this should be:
i) immediate if possible
ii) within 3 months with basic justification
iii) within 6 months with strong justification
iv) longer than 6 months in exceptional circumstances. Permission is unlikely to be granted for anything longer than 12 months.


As you have intimated, personality clashes are another reason companies transfer NBs (rare, but far from unknown). My view here is that it tends to take two to tango. If you are having a major issue with your NB, and tempers are rising, see if it cannot be handled a different way, perhaps with different people involved at either end. If at the end of the day you still want to transfer, that's fine, but it makes sense to try to do that in at least a nominal state of ceasefire.

If you are transferring because of a breakdown in relations with your existing NB, you should weigh up whether to tell your new NB. Personally I would advise that you do.

If your existing NB treats you unprofessionally, you simply shouldn't stand for it. You can complain via the company's complaint system, complain to their registrar, complain to their Competent Authority. (My view is that any/all of those complaint avenues should be last-ditch efforts. They are time-consuming and tend to raise the temperature even more.)

Aaron's tale seems extreme to me, I have to say. I imagine there is considerable background to it, and you might well get a different version from both sides of the argument!
 
C

celeo

#7
I totally agree with Roland - it should be a relatively painless process with the exception of label/labeling issues and the time, logistics and economics involved. Notified Bodies should be as co-operative as possible. They generally have a range of fees, based on device risk classification, for a company to 'roll-over'. You say your devices are Class III and I would suspect the new NB would want to do a review of the Design Dossier / Technical File to ensure adequacy of the documented evidence supporting claims of safety and efficacy. Everything today is considered on a Risk Management basis. This is particularly true for high risk devices.

One word of caution, do not change NB on the basis that the NB has been 'too tough' and keeps issuing Non-Conformance Reports for the device performance and/or associated documentation. NB's communicate with each other, so do Competent Authorities. :nope:

If the roll-over is for unsatisfactory / untimely response by the NB then that is quite legitimate and the courses of action as Roland suggests are open. Notified Bodies are on notice from the Competent Authorities to improve consistency and competency (see attached).
Yes - I am also with a NB - TUV Product Service 0123 and have lived and worked in 4 continents for them. (including UK, Germany, Japan, USA and Australia)
 

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M

morinmorice

#8
Thank you very much, both answers will help us take a decision. We know it is a big move and we want to evaluate the consequences beforehand.
Our biggest problem is that their lack of resources produced extremely long and costly delays. We were told that it is due to a lack of qualified reviewers. Can you comment on that?
 
R

Roland Cooke

#9
Turnaround time is one of the biggest reasons we attract a lot of transfers. Obviously we are no more immune from resource spikes than any other NB, but SGS really does have a very good record of timely review completion.

(I would give the credit for that to our long-suffering admin staffers who do a fantastic job of scheduling and resource allocation. :D)


In my experience, when reviews have gone badly off the rails it is rarely 100% the fault of the NB. Even if we completely forget to schedule a review we can often juggle things around to minimise the impact. I don't remember losing a client because of that kind of thing - companies tend to be very tolerant when you can demonstrate that you are bending over backwards to resolve problems.


I think what usually really sends things awry is a lack of clear communication between the client and the NB. If the review requirements / submission requirements aren't clearly understood by both sides, there is a risk that ping-ponging of questions/submissions can take place.

"Deadline-itis" can also throw a huge spanner in the works. Obviously as a NB we need a good idea when the review will start. Whilst we will try to portray the impression that you are our only client, regrettably that just ain't so. ;)

Thus if deadlines are missed, it can then be a longer time before the review can start, since commitments made to other clients need to be kept as well. So there is understandably strong pressure on the RA team to get the submission to the NB on time. Equally the RA will have made commitments to their management about getting the submission to the NB on time.

Unfortunately that can occasionally lead to submissions being sent in before they are fully complete.

Obviously the Regulatory Affairs Dept can say "Well we submitted it on time, it's the NB's fault".
Unfortunately submissions that are in a poor state will usually take MUCH longer to resolve. They are harder to read/understand, and thus take longer to review. That can mean the whole review schedule getting messed about. And of course when the review IS finally completed it will contain a large list of things that need correcting. That in turn puts the whole project back even further. It also causes stress between the NB and company - stress that would have been completely avoidable.

So it is very much in the interest of the company that there is good oversight of the submission process. Getting an independent sign-off of the file before the submission is made can be a good idea. Having the process covered by the Internal Audit programme is also advisable.

(Having worked on both sides of ths fence I like to investigate this area during audits:
"Who approves the dossier completion process as having been fully completed? How is the effectiveness of the dossier completion / submission process monitored?" )


Obviously it is very important for the company to keep in regular contact with the NB. Most NBs will be able to be flexible on start times given reasonable notice, and only send in the submission when it is as complete and understandable as possible.

For very complex reviews, face-to-face meetings ahead of time can be beneficial to both sides.



Your post seems to indicate that your NB simply doesn't have the resource to cope with your demands. If so you possibly made the wrong choice in the first place, or at least didn't keep track of your relationship if things changed over time. Alternatively the resource at the NB changed, either they lost some people, or perhaps they are simply a victim of their own success.


At this point therefore I think you have several options:

1) transfer completely - this is a considerable project of course, but it can be managed, as discussed above

2) transfer partly (e.g. all new products can be certified by a second NB) - there are quite a few companies that have more than one NB - this option is a little bit scary, not least because it can be expensive, but it does give you some flexibility in not having all your eggs in one basket.

3) live with it, but work much more closely with your existing NB to manage future projects in a timely manner. (Obviously this is good advice for everyone...:) ).



In my pre-edited version of this post I put in a footer saying "You may even want to offer more money". I realised I should have expanded that statement to make it clear what I meant.

My point is that if turnaround time is absolutely critical to you, and the costs of review are greatly outweighed by the cost of launch delay, talk to the NB about how you can help fund increased flexibility and/or increased resource.

At the very basic level, most NBs will have set rates, although some may offer premium services for an increased fee, e.g. a guaranteed initial response within a set time. (There are issues with that approach.)

Alternatively you could pay for pre-review sessions. This could be the form of a face-to-face meeting with the reviewer, to discuss the general structure/content of the submission. This would serve to strengthen the final submission.

NBs tend not to like receiving submissions in dribs and drabs, it makes taking an eagle-eye's view of the whole submission very difficult. However in some situations a modular submission approach is acceptable.

Another alternative, potentially expensive, is that you could reserve additional blocks of review time well in advance. The risk is that may never be used by you (due to the submission being late). If the NB can fill those blocks with other work you will probably not be charged, if they can't fill in the time then you would lose your "deposit".


I hope this information helps. Everyone is always welcome to drop me a PM if you need a confidential discussion about your situation/options.
 
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