The last few years have seen an explosion in popularity of certain beauty treatments such as laser hair removal, laser skin treatments and liposuction. As some of these treatments can be carried out without a medical professional they can generally be perceived as relatively safe, however they are not without risk.
Following implementation of the Medical Devices Regulation (MDR) on 26 May 2021, certain EU Member States recognised the risks associated with the devices used to carry out such treatments. On 28 July 2022, these Member States sent a letter to the Commission (Letter) requesting the reclassification of several active products without an intended medical purpose by way of derogation from the MDR, to ensure an appropriate conformity assessment of those active products that is consistent with their inherent risks before their placing on the market.
In response to the concerns raised in the Letter, the European Commission (Commission) has proposed a draft implementing regulation on the reclassification of certain active products that do not have an intended medical purpose but will fall within the scope of the MDR. These products include laser and light devices for hair removal or skin treatment, liposuction equipment, and brain stimulation devices.
2. Current position
The classification rules on active devices in sections 6.1 and 6.2 of Annex VIII of the MDR refer to an intended medical purpose for therapy and diagnosis, and therefore cannot be applied to active products without an intended medical purpose. Products without an intended medical purpose are classified as Class I under section 6.5 of Annex VIII of the MDR. Class I covers products that pose the lowest risk to users, and Class III covers products that pose the highest risk. The higher the risk posed by the product, the more onerous the requirements on the manufacturer. However, the products highlighted in the draft implementing regulation that currently fall within Class I can pose significant potential risks. For example, the risks associated with laser hair removal and laser skin treatments include superficial burns, inflammation, pain, pigmentation change, erythema, hypertrophic scarring, and blisters.
3. Effect of the draft implementing regulation
The draft implementing regulation seeks to address the significant risks associated with some beauty and brain stimulation products. It proposes the following reclassifications:
- Class IIa: Equipment that emits high-intensity electromagnetic radiation, such as lasers and IPL equipment for hair removal
- Class IIb: Equipment that emits high-intensity electromagnetic radiation, such as lasers and IPL equipment for skin treatment
- Class IIb: Equipment intended to be used to reduce, remove, or destroy adipose tissue, such as equipment for liposuction etc.
- Class III: Equipment intended for brain stimulation, such as transcranial magnetic or transcranial electric stimulation
The purpose of the Commission’s proposed reclassification is to ensure that these devices are classified in accordance with their risks and subject to the same market requirements as comparable medical devices. Therefore, the effect of the proposed reclassification is to change their applicable conformity assessment procedure under the MDR, such that the manufacturer would not be able to conduct a self-assessment and would be required to involve a notified body as part of the conformity assessment procedure.
4. What happens next?
A feedback period for the receipt of submissions on the draft implementing regulation recently closed on 8 September 2022. The Commission adoption of the draft implementing regulation is planned for the third quarter of 2022, and will enter into force on the twentieth day following its publication in the Official Journal of the European Union. Manufacturers should assess their products in advance of the regulation coming into effect to ensure compliance, and thereby avoid delays and barriers to placing their products on the EU market.
Contributed by Grainne Carr