Is the Dermaroller® a CE marked medical device? Are any of the alternative skin needle-rollers CE marked?

In order to be able to distribute a medical device in either the United Kingdom or in the European Union (EU) member countries, a manufacturer must comply with the European Medical Directive MDD 93/42 EEU.

Before a sterile medical device can be distributed the manufacturer and the manufacturing process must be inspected, audited and certified by a Notified Body.  A Notified Body is nominated by the EU and its main function is to assure that all manufacturers of medical devices conform to EU Medical Directives. If a manufacturer conforms then it can bear the CE Marking which means that the manufacturer has complied with all of the essential requirements listed in each Medical Directive. A Certificate of Conformity is then issued to the manufacturer by the Notified Body and the packaging must bear a CE mark accompanied by the Notified Body unique number which can be easily checked and verified.

Dermaroller® medical devices are classified as a Class II in Europe (Class I in the US). Our sterile single use medical devices are the only sterile skin-needle rollers in the world that comply with the European Medical Device Directive MD 93/42 EEU. Dermaroller® has earned a Certificate of Conformity issued by MedCert, Germany. Our manufacturing process is certified according to ISO 13485, the medical device manufacturing standard, and our products bear the CE mark.

Regulatory compliance of the manufacturer, manufacturing process and the quality of the devices are your assurance of safety and quality. Only the Genuine Dermaroller® meets this standard - do not accept substitutes.

Note: As you do your online investigation, you will be advised by other sites and manufacturers of skin-rollers that the abovementioned facts are meaningless. Be informed, be aware. Ask yourself, why would Dermaroller® go through all the trouble to be certified? The answer is simple. We comply with the laws and standards of the US, Europe and Australia. It considers your safety and well being paramount.

Testimonials
"I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care. "
Ira Lee NP
Dermaroller Practitioner
See More Testimonials >
"As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars. "
Jorge Moreno DO
Dermaroller Practitioner
See More Testimonials >
"My client's, co-workers, and myself are amazed and thrilled with my results. "
Maggie Griffith , HairArts Spa
https://dermarollerus.com/sites/default/files/styles/300x424/public/small.jpg?itok=mlb3KitU
"I recommend Dermaroller treatments to my friends all the time. "
Tammy H , Medical Dermaroller Patient
https://dermarollerus.com/sites/default/files/styles/300x424/public/small.jpg?itok=mlb3KitU

Recent News

New York, NY – In recent years, micro-needling roller devices have been appearing everywhere, although many consumers are still unaware of the risks they take by using rollers manufactured in less-than-ideal conditions. Those who... (read more)

Reno, NV - On Thursday, Nov.15, from 6:00 to 8:00 p.m., the Nevada Center for Dermatology will host an open house at their Reno office (650 Sierra Rose Drive, Suite A, Reno, Nevada). The evening will feature Dermaroller... (read more)

Los Angeles, CA - Once again, Dermaroller ® has created a product that leaps ahead of the competition. Now, with eDermaStamp®, Certified Dermaroller Providers are able to mechanically treat patients’ stretch... (read more)

FAQs

"Where do I go to see if a micro-needling company is Registered with the FDA?"
"Am I safe even if a micro-needling company claims that it is FDA registered?"
"Can any one perform medical micro-needling?"
"Can I achieve the same results if I use a micro-needling device at home?"
"There are a lot of companies claiming to be FDA Approved. Is Dermaroller® FDA Approved?"
"If I use my micro-needling device more frequently will I achieve better results?"
"Are thinner needles like acupuncture needles better?"
"Are all micro-needling device needles engineered the same?"
"If a roller has more and longer needles, will I get better results?"
"Can micro-needling devices be cleaned or sterilized for repeated home use?"
"Can a medical micro-needling device be reused?"
"Is the Dermaroller® a CE marked medical device? Are any of the alternative skin needle-rollers CE marked?"
"Why should I use a trained practitioner and an authorized Dermaroller® Clinic?"

Testimonials

I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care.

As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars.