ISO 13485 and CE weird budget (Quotes)

#1
Hello all,

We are negotiating with some notified bodies that still accept MDD submissions. As we already have an ISO 13485 certificate (with a certifier company) I first asked budgets just for the CE Marking.

However and by curiosity, after received the CE budget with stage 1 and stage 2 (QMS) prices, I asked my favorite one a budget to ISO 13485 certification too, and here comes the problem.

In the CE budget, they are charging 6.000€ to stage 1 and 2 audits (QMS review) and in the ISO 13485 budget, they are charging 2.900€ o stage 1 and 2 audits, same man/day in both, I asked if the audit team will be the same and of course, will be.

So I can't understand if they will not enlarge the number of audit days why we have to pay to the same service twice? And why in the CE budget they are charging more than double? It is normal?

I never had this situation before so I'm a little bit lost.

Thank you
 
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Mikilk

Involved In Discussions
#2
usually, the audit timelines are a bit different and but there are additional aspects such as - the level of the auditor, the liability of the Notified Body approving a device under CE certificate, costs of their accreditations etc.
 

Watchcat

Trusted Information Resource
#3
The value of a service or product is ultimately whatever the market will bear, and what the market will bear is usually determined by supply and demand. There are probably some other factors in play, but I doubt any of them come close to justifying charging twice the cost for essentially the same audit by the same audit team. I think mostly the NB has determined that customers will pay twice as much if the audit is to support CE certification than if it is to support ISO 13485 certification.

In the current environment, with many companies desperate to get many, many devices re-certified under the MDD while they still can, the demand for an audit to support CE marking is high, and the supply (number of NBs available to conduct the audit) is low. In contrast, demand for ISO 13485 certification independent of CE certification is, as far as I know, pretty much the same as always and the number of organizations that can issue those certificates is greater than the number of NBs available to issue CE certificates under the MDD.

PS "Normal" is not a word I would use to describe anything related to the EU and medical devices these days.
 
#4
usually, the audit timelines are a bit different and but there are additional aspects such as - the level of the auditor, the liability of the Notified Body approving a device under CE certificate, costs of their accreditations etc.
The question is, they told me that the team is the same, so how can they charge for 2 services when they are used at the same time and the same team?
 
#5
In contrast, deman
The value of a service or product is ultimately whatever the market will bear, and what the market will bear is usually determined by supply and demand. There are probably some other factors in play, but I doubt any of them come close to justifying charging twice the cost for essentially the same audit by the same audit team. I think mostly the NB has determined that customers will pay twice as much if the audit is to support CE certification than if it is to support ISO 13485 certification.

In the current environment, with many companies desperate to get many, many devices re-certified under the MDD while they still can, the demand for an audit to support CE marking is high, and the supply (number of NBs available to conduct the audit) is low. In contrast, demand for ISO 13485 certification independent of CE certification is, as far as I know, pretty much the same as always and the number of organizations that can issue those certificates is greater than the number of NBs available to issue CE certificates under the MDD.

PS "Normal" is not a word I would use to describe anything related to the EU and medical devices these days.
Thank you Watchcat! Seams that they are clearly abusing the need of the market. I hope the situation will stabilize in Europe or startups like us will not be able to survive
 

twanmul

Involved In Discussions
#6
They are charging for the assessment of two certifications separately, though are combining the assessments within the same timeframe. This is nothing unusual - at best, you could see this as saving you additional inspector fees (more nights & expenses etc) but at worst, you could see this as a fee to tick a box (which I admit is what it looks like).
The unfortunate thing is that this charge is usually separate to the cost of issuing the certificates (depending on your NB) and even the differing length of certificate validity (5 years for the MDD QMS certificate and 3 years for the standard certificate - be careful on your certificate validity on the QMS - this will expire in line with the MDR transitional arrangements) doesn't really help you as you're still charged regularly.
I suppose that they know going to another accredited body to get ISO 13485 certification separately will cost you more anyway, so the fee is slightly less.
I suppose you're lucky you've found an NB who is taking on new devices under the MDD still and take solace in the fact that all NB's will have to publish their fees publicly under the new regulations!
 
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