CE marking

yeah

and then also things like like we said appliances warranties guarantees um uh extractions or air extraction alarm systems what what the actual fittings are where they were purchased from sometimes but certainly what the supplier of them are um and Essentially, for us in the UK, in England, we're looking for products that are CE marked, so they're good quality product.

You can't just go and buy anything from eBay and stuff.

And it has to be...

600 things that you can't legally sell in Israel unless the SII, or a lab the SII recognizes, has tested and certified them.

Even if the product already carries a European CE mark.

even if it's already been tested in a German lab.

That's where the cost of living argument comes in.

That's a tax on Israeli companies trying to compete globally.

A power strip

maker in Petit Tikva has to get SI32 certification for the Israeli market and CE certification for the European market.

Same surge protection circuit.

So all of that fine rolls downhill in the way of tighter, essentially in the form of tighter regulatory compliance requirements.

So every single brand that's selling on it all of a sudden has to prove that their CE certificate is legitimate and not just a purchase one.

They have to prove and provide their risk assessments.

You know, I've heard recently with the Amazon one, particularly on cosmetics, Amazon now are asking for more data in terms of the cosmetic safety report, the CPSR.

It's common knowledge that testing certificates can be purchased.

You don't actually go through the testing regime.

So you must do your due diligence in order to ensure that the testing certificates, the CE certificates, are done with reputable testing houses.

In the main, the European testing houses have Chinese offices, and you can verify that that certificate is legitimate.

Then there, another reason why it's difficult is the, the regulation.

Uh, the regulation is, is coming there, but it's, it's hard to get the right, uh, FDA approval or, uh, CE markings that you need to get this model, uh, in, into a prospective clinical trial.

Yeah, no, it did sound difficult, and, and we see this across many areas of, of AI, right? Uh, this regulatory lagging behind because the, the pace of development is, is so, so rapid and so fast.

Um, just to sum up, Nick, what, what would you say are the sort of key takeaways of your review that people who may be not as immersed in this field as you, but they should, uh, sort of pay attention to and take away from your paper?

Lo founded Anouvo with his mentor, Dr. Wen-tai Liu, and since then has led the company through pli- pre-clinical and clinical translation to regulatory clearance and commercialization.

EksoStim has received both CE mark and FDA clearance, and is commercially available for clinic and home use.

And Dr.

Rose Tilton is an occupational therapist who specializes in adult neurorehabilitation, working with clients with CVA, SCI, and TBI.

So you won't be, you won't be out of dated, but as time goes by you are even better, right? And that's why I decided to spend time and dive into this bioengineering or neuroengineering field.

And in the very beginning, actually, we were working on retina implant.

So me and my co-founder, we spent decades in the retina implant, so the product got FDA approved, CE marked already, right? And by, by a, a company that collaborated with us.

And after our retina project was done back in 2012, we was, "Now what, you know, should we do?" And then we explore BCI, brain computer nerve, brain computer interface in spinal cord, then eventually we decided to work on spinal cord injury with our collaborator UCLA.

What has changed most dramatically isn't the condom's basic design, but the bureaucracy wrapped around it.

In the European Union, condoms have been legally classified as medical devices since a 1993 directive meaning every product must clear the essential safety and performance requirements laid out in European Union law and be certified by an independent notified body before it can carry the CE mark according to a European Parliament record addressing exactly this classification.

That framework has since been folded into the EU's broader medical device regulation which requires manufacturers to run a documented quality management system, compile technical files and submit to post-market surveillance, the same regulatory machinery used for far more complex devices.

as selling a device without valid CE marking anywhere in the European Economic Area is, in principle, a serious violation that can trigger seizure and market withdrawal, precisely the mechanism French authorities invoked this week against the unlabeled online listings.

The United States takes a parallel but different route.

The FDA classifies condoms as Class II medical devices, a category that also covers pregnancy tests and powered wheelchairs, for example, requiring manufacturers to meet performance standards including water leak and airburst testing.

The condom is cheap, requires no prescription and works against both pregnancy and infection at once, advantages no other single method matches.

But those same qualities make it dependent on a functioning, largely invisible system of manufacturing standards, batch testing and labeling rules that most users never think about until, as happened in France this week, a regulator says otherwise.

That's where we want to focus on with first the clinical treatment.

proof, then at the same time getting the CE approval.

We already are CE approved, but for the uterus.

We want to be CE approved for the kidney and work, of course, on regulatory process in the US with the FDA.

So now all the rights of our patents belong to Science Corporation, which is located in Alameda in California.

And they applied for CE Mark.

It's a European equivalent of FDA approval based on the results of this clinical trial.

We hope to achieve this certification approval this year, maybe even this summer.

It's about the whole holistic environment and approach.

Look out for ma- for machines that are medically CE marked as well-

Yeah

... because that will be-

Mm.

At, at the moment, if it's just cosmetic treatments that you're doing, the machine doesn't have to have a medical CE mark, but that has changed now.

So under the new CE European medical devices regulation, even if they're doing cosmetic treatments, you have to, um, the machine has to be CE marked to, uh, as a medical device.

Yeah.