On many websites, lasers and body shaping equipment carry a badge: “CE”, “medically certified”, sometimes “FDA”. What those labels actually mean is rarely explained. That is a pity, because as a salon owner you are responsible for the safety of your clients and you want to know what you can rely on. This article explains the basics. It is not legal advice; for your specific situation, consult a specialist.
The MDR in brief
Since 2021 the Medical Device Regulation (MDR, Regulation 2017/745) has applied in the European Union. It replaces the older directives and sets stricter requirements for medical devices: for the design, the clinical evidence, the manufacturer’s quality assurance and the surveillance after sale.
Important for our sector: in Annex XVI, the MDR has also brought a number of products without a medical purpose under the regulation. These include devices using high-intensity light, including lasers and IPL for hair removal, and devices that reduce fat tissue, such as cryolipolysis. For these groups, what are known as common specifications have been laid down, which have applied since mid-2023. In plain language: a laser for cosmetic hair removal must meet medical safety requirements in Europe, even though the treatment itself is not medical.
What a CE marking tells you
CE means that the manufacturer declares that the product meets the European requirements. For medical devices in the higher risk classes, an independent body, the notified body, must assess this. You can recognise that by the four-digit number next to the CE marking. A CE marking without such a number on a device that does fall under the MDR is a reason to ask further questions. When buying, always ask for the declaration of conformity and the certificate, and check that the type number on them matches the device you receive.
Also watch out for confusion with other CE marks. There is a mark that looks very much like the European CE marking, but stands for “China Export” and says nothing about conformity. The spacing between the letters is the difference; a specialist sees it straight away.
What it does not mean
Certification says something about the device, not about the practitioner. Which technology to choose is covered in our comparison of diode, IPL and alexandrite. A medically certified laser in untrained hands is still unsafe. And “FDA” is an American designation that has no legal status in Europe; it can be an indication of the quality of the device, but it does not replace the CE marking.
What you take care of yourself in the salon
Certification is the start, not the end. In practice, safety is about habits: an intake in which you ask about skin type, medication use and contraindications, a test flash for a new client, safety goggles for everyone in the room, maintenance in accordance with the instructions and recording the settings for each treatment.
Also ask your insurer whether your liability insurance covers laser and body shaping treatments; that cannot be taken for granted.
Why we explain this
We show the “medically certified” badge with our lasers because the devices meet the requirements of the MDR. But we believe you should be able to understand what that means before you rely on it. Feel free to ask us for the documentation; we are happy to show it.