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IPL and Laser Device Regulation
Since the implementation of the Medical Devices Regulation on May 26, 2021, there have been notable changes in the regulations for IPL and laser device used in medical treatments. These devices are now held to more stringent requirements, and manufacturers must comply with these rules to guarantee the safety of IPL and laser treatments.
According to the EU Medical Devices Regulation (MDR), Annex XVI, Paragraph 5, IPL and laser equipment fall under the category of “High intensity electromagnetic radiation equipment.” These devices are intended for use on the human body and include sources like infrared, visible light, and ultraviolet light. This classification encompasses lasers and intense pulsed light (IPL) equipment used for various skin treatments, such as skin renewal, tattooing, and hair removal.
During IPL or laser treatments, the equipment emits intense beams of light of specific colors. This light energy is crucial for heating the pigment in the hair and skin, leading to the destruction of cells in the hair follicle, ultimately preventing hair growth. As a result, IPL and laser equipment are officially classified under the MDR as a form of skin treatment involving hair removal.
The EU MDR provides the definition for IPL and laser equipment in Paragraph 5 of Annex XVI, stating:
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 color. Both treatments have ‘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. Therefore, IPL and laser equipment are classified under the MDR as a form of skin treatment involving hair removal.
IPL and Laser Device CE Marking
As per EU Medical Devices Regulation, IPL and laser device fall into Class IIa or Class IIb has many rigorous requirements. Manufacturers of these devices must ensure compliance with both general safety and performance requirements (GSPR) outlined in MDR. Additionally, a crucial step in the process is the clinical evaluation of the device.
For the product to be legally marketed, it must bear the CE mark. However, since it is classified as a Class IIa/IIb or III device, the assessment of its compliance and safety is checked by a Notified Body. The Notified Body thoroughly examines whether the product meets all the legal requirements and safety standards along with manufacturing activities and QMS. This oversight is regulated by the European Commission. Once the Notified Body approves the product, it receives the CE mark, signifying its compliance, and can then be placed on the market.
Note:
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.
I3CGLOBAL has a team of medical device regulatory professionals dedicated to assisting manufacturers in meeting the EU Medical Devices Regulation (MDR) requirements, specifically for Annex XVI products. Our expertise can be instrumental in helping manufacturers attain Medical Device CE Marking
Manufactures interested in learning more about the specialised support offered by I3CGLOBAL for their specific needs related to EU MDR compliance, please reach out to us.
Timeline for MDR approval for Annex XVI Cosmetic Device
Timelines vary by Notified Body workload and device complexity, but manufacturers should generally budget well over a year when clinical evaluation in legacy devices and or investigations in new IIb or III devices, Common Specification testing, and Notified Body review cycles are all factored in earlier engagement with a Notified Body and regulatory consultant is strongly advised given current backlogs.
A couple of these areas (exact transition/compliance deadlines, and how strictly individual Notified Bodies are enforcing the Common Specifications right now) are moving targets, so it’s worth confirming the latest position directly with I3cglobal’s regulatory team or a Notified Body before finalising a submission timeline.
Frequently Asked Questions
How are IPL and laser devices classified under EU MDR?
They fall under Annex XVI, Group 5 (“high-intensity electromagnetic radiation equipment”) when used for aesthetic purposes such as hair removal, skin renewal, or tattoo removal even though they have no intended medical purpose. This classification generally places them in Class IIa, IIb, or III depending on invasiveness and duration of use, per Article 1(a) of MDR.
Do we need a Notified Body even though our device has no medical purpose?
Yes. All Annex XVI products require Notified Body involvement in the conformity assessment comparable to the procedures used for Class III devices regardless of the device’s actual risk class.
What are the ``Common Specifications`` everyone mentions for Annex XVI devices?
These are technical requirements published by the European Commission (Regulation (EU) 2022/2346) covering safety, performance, risk management, clinical evaluation, and labeling for Annex XVI product groups, including IPL/laser equipment. Compliance with these Common Specifications is mandatory in addition to the MDR’s General Safety and Performance Requirements (GSPRs).
Is clinical data mandatory, or can we rely on literature and equivalence?
Clinical evaluation is mandatory for Annex XVI devices, and manufacturers must demonstrate an acceptable benefit-risk profile. Depending on the device and its risk class, this can require actual clinical investigation data rather than literature/equivalence alone, plus a post-market clinical follow-up (PMCF) plan.
Our device is already CE marked as a cosmetic/consumer product — can we keep selling it?
No. Once a device falls under Annex XVI, it must go through full MDR conformity assessment with a Notified Body; a general consumer-product CE mark (e.g., under the Low Voltage or EMC Directives alone) is not sufficient once the device is caught by Annex XVI.
Do home-use IPL devices face the same requirements as professional/clinic devices?
They fall under the same Annex XVI framework, but the Common Specifications and risk assessments account for lay-user risk, so usability engineering, labeling, and instructions for use typically require additional scrutiny compared to professional-use devices operated by trained personnel.
What technical documentation do we need to prepare?
A full technical documentation file aligned with MDR Annex II/III, including device description, risk management file (ISO 14971), clinical evaluation report, biocompatibility data (if applicable), verification/validation testing (e.g., IEC 60825 for laser safety, IEC 60601-2-57 for light source medical equipment), labeling/IFU, and a post-market surveillance (PMS) plan.
Do we need an EU Authorized Representative if we're a non-EU manufacturer?
Yes, any manufacturer outside the EU placing an Annex XVI device on the EU market must appoint an EU Authorised Representative (EAR), the same as for any other MDR-regulated device.