Dr Aesthetics - Facial Rejuvenation

Is the Dermaroller™ a CE marked medical device and are any of the alternative skin needle-rollers CE marked?

To supply a medical device in the UK and the rest of the European Union the manufacturer must comply with the European Medical Device Directive MDD 93/42 EEU. To supply a sterile medical device the manufacturer and the manufacturing process must be inspected, audited and certified by a notified body and be able to provide a Certificate of Conformity issued by the notified body and the packaging must carry a CE mark accompanied by the notified body unique number which can be easily checked and verified.

Dermaroller™ Class IIa sterile single use medical devices are the only sterile skin-needle rollers in the world that comply with the European Medical Device Directive. They have a Certificate of Conformity issued by MedCert, Germany, are accordingly CE marked and their manufacturing process is certified according to ISO13485, the medical device manufacturing standard. Regulatory compliance of the devices and the manufacturing process are your assurance of quality. Only the Genuine Dermaroller™ meets this standard - do not accept substitutes.

Some skin needle rollers claim to be FDA approved and/ or registered, some even have the FDA logo on the pack and websites, does this mean they have a similar seal of quality and external validation and approval that the Genuine Dermaroller™ CE marking and European medical device certificates provide?

Compliance with the regulatory standards conveys assurance of quality and safety profile. It must be for this reason that a number of the needle-rollers, their distributors and re-sellers claim "FDA approval" or "FDA registration" and have the FDA logo printed on the packaging, literature or websites. Unfortunately none of the rollers can claim to have FDA clearance and can not state that they are "FDA approved", "FDA registered" or use the FDA logo. As you may be aware some of them do and this is mis-branding. Skin-needle rollers that currently make themselves available in the USA have found a way of doing so by self-classifying as a Class 1 Device described as a ‘manual surgical instrument for general use’ and as such should make no therapeutic claims.

Accordingly, under FDA 21 CFR878.4800, devices that fall in to this category are exempt from the FDA 510(k) pre-market notification requirements and it is only necessary to register the establishment and the device with the FDA on their website prior to sale. This is purely an administrative process and it does not permit use of the FDA logo or convey assurance of quality or approval.

To quote the FDA 21 CFR807.39;
"Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding."

Furthermore you will find the following statement on the FDA website;

"Misuse of FDA’s logo may violate federal law; FDA’s logo should not be used to mis represent the agency nor to suggest that FDA endorses any private organization, product, or service".

Dermaroller SARL currently makes the Genuine Dermaroller™ available on a limited scale in the USA by this mechanism also. It is a grey area but they do play by the rules and neither they, nor we, make false claims about this status.

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