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Estimated cost for MDR certification

ShRam

Starting to get Involved
#1
Hi guys,

I want to know the estimated cost to get an MDR certification for a Class III device. Where can I find such information? If someone knows the base fee please share it here.
 

Marcelo

Inactive Registered Visitor
#3
Standard fees are now obligatory to be public (as a way to improve transparency and to prevent "shopping" for services), and you can find them on the MDR-designated NBs websites (you can see for TUV SUD here: Frequently Asked Questions on Medical Device Regulation | TÜV SÜD) however, they are only general ones (in the TUV SUD example, they only put hourly rates) and thus you still have to evaluate how much time is required (as it really depends from manufacturer/device to manufacturer/device.
 
#4
If you are talking about a cost for the actual certification, I don't know if there is a base fee. If there is, I don't think anyone knows what it is, and, if they did, in spite of the weak efforts toward transparency, I don't think anyone is going to share. There is probably a confidentiality clause in the contracts. I haven't seen BSI's transparency effort, but as a consultant, and MBA, and someone who managed business proposals for a global CRO, hourly rates tell you nothing.

The two NBs that have been designated might charge flat fees for their certification services or they might not. If so, they might have finalized their fee structure by now, or they might not. However, most flat fee structures are based on experience doing the same thing over and over. As far as I know, no NB has yet certified a device under the MDR. BSI and TUV might feel they have the financial resources to roll the dice in order to secure market share and then cover losses if their initial fee structure turns out to be too low. Similarly, their clients can probably afford to pay a high fee to get in early and secure their own market shares.

Regardless, I'm guessing BSI and TUV are fully booked through at least the end of 2020 by the large established companies that got prepared early, and may well stay booked by those clients forever and ever amen. If smaller companies are going to get certification, they may have to wait/hope for additional NBs to be designated, and then find out how much those NBs are charging. As for startups, I've been telling mine for several years now that, "If you aren't already in the EU, don't go."

If you don't have RA/QA inhouse, and therefore will need a consulting firm, right now I wouldn't look to them to estimate the cost of the certification, only their own fees for helping you get it. They may have a handle on certificate costs in another few years, if their clients choose to share that information with them. As with the NBs and device companies, the larger firms might be willing to quote a flat fee, because they probably want to establish market share too, but I wouldn't count on it. As an independent, no way. I won't quote you one for FDA approval, either. Some consultants might quote a flat fee for a "me too" 510(k), because, depending on the device and its predicate, it might come under "doing the same thing over and over." Class III devices do not.
 
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#5
From BSI's website (emphasis mine):

BSI is now accepting applications for MDR
We can confirm that BSI is now accepting applications under the MDR for our UK Notified Body (0086) from 3 June 2019.
BSI UK Notified Body (0086) will begin to process quote requests and schedule work over the coming months. BSI will provide conformity assessments to the full scope of the MDR. This service will focus on our existing UK (0086) and NL (2797) clients.


I couldn't find any transparency on costs, but I would expect the costs for transitioning from MDD to MDR to be quite different from the costs of a completely new certification under the MDR.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Standard fees are now obligatory to be public (as a way to improve transparency and to prevent "shopping" for services),
I also think that such mandate will generate nothing in terms of transparency. If a NB wants to perform conformity assessment services FOR FREE, because they have a strategic interest in establishing a business relationship with a large corporation, there are no laws in the world prohibiting that.

If the regulators want more transparency in the process (and that is a good thing), there is not the way to do it, in my opinion.
 

Marcelo

Inactive Registered Visitor
#7
I also think that such mandate will generate nothing in terms of transparency. If a NB wants to perform conformity assessment services FOR FREE, because they have a strategic interest in establishing a business relationship with a large corporation, there are no laws in the world prohibiting that.

If the regulators want more transparency in the process (and that is a good thing), there is not the way to do it, in my opinion.
Agreed, however, this is not alone, in fact, if you look at all the tools mandated by the MDR, the transparency/control was clearly spread between several different requirements.
 

yodon

Staff member
Super Moderator
#8
To open the can of worms a bit wider...

Besides certification, there are certainly other costs. If you're not in the EU, you'll need an Authorized Rep.

And I think the insurance burden will increase (I don't really know but it seems there's much more in the MDR regarding liability).
 
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