17/09/2026
“Why isn’t Derma 2.0 CE marked?” Well… some of it is!
Derma-Fill Dermal Fillers and the Derma-Peel TCA Strong peel are CE marked because they are classified as medical devices. Products such as Bio, Firming, Eye, Repair and Hair etc are cosmetics, not medical devices — so CE marking simply isn't required for them in Great Britain.
This is where the confusion comes from: UK regulation specifically distinguishes between cosmetics and medical devices. They are different product categories governed by different regulatory frameworks. A product does not become “better”, “safer” or “more legitimate” simply because there is a CE mark on the box. CE is not a universal badge of quality. It is a regulatory conformity mark for products where CE marking applies. Seeing “CE” doesn't automatically mean a product is better formulated, better tested or higher quality.
Ask yourself…
- Does a CE mark tell you who formulated the product? No.
- Does CE mean it was formulated by Italian aesthetic surgeons with 20+ years of experience? No.
- Does CE mean each formulation has been independently third-party tested for purity and efficacy? No.
- Does CE mean every ingredient has been independently laboratory tested by whoever awards the CE mark? No.
- Does CE mean each ingredient has been carefully selected and independently sourced by a team of Italian aesthetic doctors? No.
- Does CE automatically mean better ingredients, formulation or product quality? No.
- Can a medical device be legitimately CE marked without the manufacturer being ISO 13485 certified? YES.
Does a CE mark guarantee any of the above? NO.
Does Derma 2.0 actually do all of the above — including operating under ISO 13485? YES. ✓
So what should you actually look at? What happens behind the scenes.
✓ ISO 22716 — internationally recognised Good Manufacturing Practice specifically for cosmetics.
✓ ISO 13485 — internationally recognised quality-management standard specifically for the medical-device industry.
✓ Independent third-party laboratory testing for purity and efficacy — not simply testing their own products in-house.
And here's the important bit: ISO 13485 is NOT required for cosmetic manufacturing. Derma 2.0 chooses to operate to both cosmetic AND medical-device quality standards, going above and beyond what's required for its cosmetic range.
“But surely CE means it’s safe?”
This is probably one of the biggest misunderstandings surrounding CE. CE does involve applicable safety and performance requirements, but it does NOT mean:
CE = safe.
No CE = unsafe.
A cosmetic that doesn't require CE isn't failing a medical-device safety standard. It's regulated under an entirely different framework. And this is where ISO 13485 is particularly relevant.
ISO 13485 is specifically designed around medical-device quality management, with emphasis on controlled manufacturing, consistency, risk management, traceability and quality processes. Derma 2.0 therefore chooses to manufacture within a medical-device quality-management system, despite this not being required.
What ISO 13485 demonstrates is that serious medical-device quality systems sit behind Derma 2.0's manufacturing, alongside ISO 22716 cosmetic GMP and independent third-party testing.
CE tells you about regulatory and marketing conformity. ISO tells you about the quality systems behind manufacturing. They are not the same thing.
“Well, if Derma 2.0 is that good, why don’t they just CE mark everything?”
Because you don't simply choose to CE mark a cosmetic because it looks good on the box. CE is a regulatory conformity route for certain product categories, including medical devices — it isn't an extra quality award that a cosmetic should try to obtain.
For Derma 2.0 to pursue CE marking for products correctly classified as cosmetics would mean unnecessarily taking them down a medical-device regulatory route that wasn't designed for them — adding considerable time, documentation, cost and administration without making the formulation, ingredients or finished product any better. Why slow down innovation just to put an unnecessary logo on the box?
By developing products within the correct cosmetic framework, Derma 2.0 can innovate and expand its range without putting every new cosmetic formulation through a medical-device conformity process that simply doesn't apply to it. That's helped Derma 2.0 build a range of nearly 50 different products — with more coming! — while still manufacturing under ISO 22716 cosmetic GMP and ISO 13485 medical-device quality-management systems, alongside independent third-party testing.
And ultimately, the results are what we should care about. We regularly have customers post Derma 2.0 before-and-afters that are so impressive somebody inevitably comments “AI!” 😂
So perhaps instead of asking:
“Where's the CE mark?”
Ask:
Who formulated it? What's actually in it? Where do the ingredients come from? How is it manufactured? What standards does the manufacturer work to? Who independently tests it? And most importantly — does it work?
We'd rather Derma 2.0 ask:
“What can we formulate next?”
than:
“How quickly can we get an unnecessary logo onto the box?”
Correct regulation. Serious manufacturing standards. Independent testing. Constant innovation. And results that apparently now need to pass the AI accusations test. 😂
