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IPL & Laser Device Regulations Unpacked

By: Lotte Dijkema – Graduate intern at NAALA 

Published on 6 April, 2023

IPL & Laser Device Regulations Unpacked

IPL & Laser Device

Lotte Dijkema

Graduate intern at NAALA

Published on 6 April, 2023

In this blog post, we’ll discuss IPL and laser equipment and the changes that have occurred due to the Medical Devices Regulation taking effect on May 26, 2021. These devices are now subject to stricter requirements, and manufacturers must adhere to them to ensure safety when using IPL and laser treatments.

So, what exactly are IPL and laser equipment? IPL, or Intense Pulsed Light, is a device that emits powerful flashes of light from a flash lamp. These flashes generate heat, which can destroy capillaries. Laser equipment operates similarly, except it uses one color of light instead of a beam. Given the risks associated with these treatments, it’s important to understand the new compliance requirements that manufacturers must now meet.

If so, the equipment used for this purpose now falls under the regulations for a medical device. This has been included by the European Union in Annex XVI of the European Medical Device Regulation (hereinafter EU MDR), which has been in effect since May 26, 2021.

The EU MDR contains the definition of IPL and laser equipment. Paragraph 5 of Annex XVI states the following:

“High intensity electromagnetic radiation equipment (e.g., infrared, visible light and ultraviolet light) intended for use on the human body, including coherent and incoherent sources, single-color and broad spectrum, e.g., lasers and intense pulsed light equipment, for skin renewal, tattooing, hair removal or other skin treatment.”

During an IPL or laser treatment, Intense Pulse Light or equipment is used which can produce an intense beam of light of a specific colour. Both treatments have a ‘captured light energy’. This light energy ensures that the pigment in the hair and in the skin is heated with the laser so that the cells in the hair follicle, which produce hair, will be destroyed. So, IPL and laser equipment are classified under the MDR as a form of skin treatment involving hair removal.

That’s a logical thought. With IPL or laser treatments, for example, people often think of nice smooth legs for the summer months. This is not surprising, since that is generally the result of IPL or laser treatment. And what’s the harm in that? The issue here is not the result, but the equipment used and its implementation. The equipment used requires expert execution of the treatment. Therefore, the RIVM has also determined that these treatments are reserved for doctors and skin therapists because they are specialists of the skin. The risk of leaving the performance of the treatment to someone who is not a skin specialist is too high.

It happens more than once that a treatment is not performed properly resulting in harmful consequences. There are risks that you won’t think of right away. One of the risks is that the device radiates laser light so it is important that proper eye protection is used by the practitioner and the patient to prevent eye damage. In addition, smoke can also take place from the device. Wearing mouth masks is one way to counteract this. In addition to those risks, the device can also be set incorrectly, causing harm to the patient. The result of improperly performing an IPL or laser treatment can cause burns, pigmentation or scarring. These risks usually occur when the practitioner is not skilled enough to perform such treatment. In principle, IPL or laser treatment is not dangerous, provided the equipment is used by qualified specialists.

IPL and laser treatments emit ionic radiation. To regulate the safety of these treatments, the European Commission has drafted a new reclassification regulation. The different classes range from class I products (low risk) to class III products (high risk). According to Article 1(a) of the regulation, the devices listed in Annex XVI under item 5, including IPL and laser equipment, are assigned to risk class IIa.

Products that fall into Class IIa are subject to relatively strict requirements. IPL and laser equipment must comply with the general and performance requirements arising from European regulations. Also, the equipment must also be clinically evaluated. To finally market the product, the product requires a CE mark. Because it is a Class IIa product, the product must be assessed by a Notified Body. A Notified Body is independent, impartial and knowledgeable. This body studies whether the product is safe and meets all legal requirements. This is overseen by the European Commission. Once the product is approved, the product receives a CE mark and may be placed on the market.

More information on EU MDR requirements for manufacturers, can be found in a previous blog.

Manufacturers who wish to market their product in the European Union under Annex XVI of the EU MDR are required to carry a CE mark. Manufacturers who hold a valid CE mark under the Medical Devices Directive (the EU MDR’s predecessor) may benefit from the transition period. Without CE marking, your product will be prohibited from entering the European market.

NAALA focuses on helping manufacturers meet the EU MDR requirements to achieve CE marking for Annex XVI products. If you would like to learn more about how we can provide specific support for your needs, please feel free to reach out.

Questions? We are happy to discuss your specific case.


Medical Devices without an intended medical purpose are considered to have the same characteristics and risk profile as medical devices and therefore must meet the same general performance and safety requirements. The European Commissions has proposed Common Specifications for risk management and transitional provisions benefitting clinical evaluations. 

Do you manufacture facial fillers? You might be developing a medical device. The industry of facial or other dermal fillers have faced several regulatory changes over the year. Historically, dermal fillers have been marked as medical devices, medicinal product, or cosmetics. With the applicability of the EU MDR last May, the EU has tightened the requirements applicable to facial fillers. Following the EU MDR, facial fillers qualify as medical devices