The fallacy of the CE Mark

Due to a Notice of Concern issued under s14(2) of the Defamation Act 2005 (NSW) by Oncosil Limited (ASX : OSL) this post has been removed. Sorry.

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5 thoughts on “The fallacy of the CE Mark

  1. Excellent points Chris.I was at an Industry/TGA conference in Canberra a couple of weeks ago discussing this very topic.

    I don’t think it’s well understood (outside of regulatory circles) that CE is given by notified bodies(sort of like your private building surveyor approving a building),not ‘Europe’ or a government organisation ,although a government organisation can be a notified body,like the TGA in Australia.You pay them alot for this consulting service.

    Oncosil paints the picture of the Notified Body in a different way – what it should say is ‘the guys we pay a bunch of money to ,to help us gain the ‘CE’ mark,are going to come back to us in a few weeks and lets us know how we’ve all done.

    The face to face ‘Fast Track’ statement had me intrigued,so I looked into it.I reckon it just means their own consultants paid a face-face visit to their offices….
    Here is a company that provides such a service :

    There was a big scandal recently when a whole bunch of notified bodies turned out to be just doing a tick and flick in return for their fees,this was the case with the French company PIP ,think industrial strength silicone breast implants.This is a link to the TGA’s blacklist – if you have CE from these guys you’re in trouble.
    As you point out,getting ‘CE’ doesn’t say your device actually works,it doesn’t even say that it is safe to use on a patient,all it means is that a private firm certifies that the device you make,is made the same way every time,and from the same materials,and you can track and trace where everything came from.

    You kind of expect someone who makes devices to be able to conform with these minimum standards anyway.If a company wants to avoid CE because it is too hard,that should ring alarm bells.Fair enough though if they just can’t be bothered trying to do business with the Europeans,but you’d be missing some quality business out there,including the UK,Australia and Canada -there alone is 120 million English speaking (cheap for marketing),high value (we all pay too much),reasonably uncorrupted ( level playing field in terms of tenders etc) potential users… you’d be nuts to turn away from that.

    With the US and it’s GPO’s and insurers dominating the market ,together with the competition,if you fail to get that deal with the GPO or reimbursement from a major insurer,it could make things very difficult across the whole of the market,not just a little piece of it.

    Depends on the particular device and circumstances,but I think for the majority of say Class I -III devices,especially from small start-ups,I’d go CE over FDA any day .


    • Excellent contribution, Nick. Many thanks.

      Agree with you about most things although I would say CE vs FDA really depends on the product (as you also allude at the end). Some products are really a no-brainer but some fall into the expertise “cracks” of notified bodies and can get a company into all kinds of trouble downstream.

      For me it is not “cut and dry”, it’s very much a product-driven decision.

      I think there is also a bit of “bogey-man” mentality with the FDA, mainly because of the dramatic overhaul of class III/PMA, that made a lot of people feel like marking approval was harder than it had to be in the device space.

      There is actually a fair amount of conformity between the two worlds but the market dynamic post-approval is very VERY different and this is often insufficiently understood by investors and management alike.


  2. ‘Some products are really a no-brainer but some fall into the expertise “cracks” of notified bodies and can get a company into all kinds of trouble downstream.’

    Yes, and most CE certifiers have little experience with implantable radioactive devices.

    You make a very valid point about the CE mark – it really is about conformity to standards and having a repeatable and robust manufacturing process that is audit able from start to finish. This is where so many fall over. However it is a money earner for the certification mobs and they will keep working, sometimes for years, to assist in obtaining the mark. Or at least until the $ run out.

    Keep up the good work. Don’t agree with everything you say, but pretty much on the ball for my money.


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