Clinicians should not take CE mark as an alternative to clinical evidence
We see many press releases about new regulatory approvals on both sides of the pond. As our readers and any medical device industry watcher will know, there exists plenty of argument about which kind of regulatory clearance, FDA or CE, carries the most weight. It’s a significant and endless debate and one which features prominently on Linked-in’s medical device group discussion forum.
Quite clearly it’s not anything like as simple as it might sound to decide which is “best”, although as a general statement we’d say Europeans all think CE is “easier” to attain while Americans often think it’s FDA, at least at 510(k) level.
But here’s the thing. News releases about FDA approval, even 510(k) clearance, nearly always quote some study on which the clearance was based. Even 510(k)s, which are less demanding of clinical data, usually reference clinical experience.
News releases about CE mark approvals frequently do not, and we think this is a major weak spot in the argument for CE marking as the “better” process, because we suspect the clinical evidence barrier is lower than it should be.
Press releases sometimes make us more sceptical
We’ve come across a few new products in recent weeks where our healthy scepticism, far from being assuaged, has actually been reinforced by the company press release. You know the kind of thing… some kind of overblown claim about the magical properties of this new device, zero evidence provided, no mention of seeking FDA approval, now seeking distributors.
So, we’re accepting fully the fact that our argument may be a bit unfair. These new gizmos may have passed muster with their notified bodies(NB) based on a whole pile of brilliant bench work and pre-clinical data and even have been used in human trials. Or, if they’re class 1 devices, not requiring of NB approval, we expect companies to have armfuls of their own data to support the product.
It’s about perception… and evidence
The point here is that whether or not we like and respect the CE mark process is less than important. What matters is two things. Firstly perception. If a company trots out the story along the lines outlined above, forgive me for thinking the device is devoid of clinical support. At least give us something to warm our Doubting Thomas cockles or we’ll start thinking all you’ve done is provide the authorities with a folder full of partisan background material and a bit of bench testing. Surely someone’s used it, even in a short observational study basis, and preferably someone who didn’t invent it. What did they find? How did it perform? Were they encouraged? Will they now be doing a bigger study? PLEASE TELL US.
Secondly, if I was a medical professional, even just a little versed in regulatory affairs, faced with a newly CE marked product that wasn’t FDA approved/cleared/choose your own word, in this world of scandalous breast implants and significant media antipathy towards device regulators and companies, I’d really want to know on what basis the device was approved. Not just for my own reassurance, but because if I’m going to use it, I’ll need to convince someone to buy it. It’s all in the evidence and if you don’t produce some we’ll assume there isn’t any.
How hard can it be?
This all brings us full circle to the age-old problem of how to get a body of evidence prior to approval. Well, sadly that’s an argument that doesn’t stand up too well, because it’s inherently possible to put your product through a human study in a UK teaching hospital prior to regulatory approval. The only problem is the time it takes, which involves IRAS(Integrated Research Application System) forms, ethics committees, R&D committees. It’s questionable whether the workload is even heavier than that required for CE mark approval, although of course this depends on the classification of the device. But in a straight fight one could imagine gaining CE mark approval would look far more valuable and attractive to a company than a clinical study, not least because it opens the door to virtually unfettered use of one’s product.
If you don’t have the evidence, don’t squeeze the product through the regulatory process
So here’s the plea. If you’ve got a new device and a new CE mark and you want to tell the world about it, make sure your evidence is at least summarised in the release because you really want to look credible and persuasive don’t you?
If you don’t have the evidence, don’t issue the release. Oh and perhaps take a look in the mirror (along with your NB).
By Nick Woods