The European Commission has adopted a draft implementing regulation that will up-classify certain products without a medical purpose that nevertheless fall within the scope of the EU’s Medical Devices Regulation (MDR). The affected products include certain hair removal, skin treatment, liposuction and brain stimulation devices.
Annex XVI of the MDR contains a list of products that do not have a medical but rather an aesthetic purpose. The MDR includes a risk classification process wherein products falling within Class I are considered to pose the lowest risk to patients and Class III poses the highest risk. The higher the risk class of a product the more pre-and post-market obligations that the MDR places on the manufacturer.
The preamble to the draft Regulation provides that, as active products without a medical intent, the products that fall within its scope were previously considered to be regulated as if they were Class I medical devices. At the request of a number of EU Member States, the Commission is now proposing that some active products falling within Annex XVI are up-classified as follows:
|Product / Procedure||Proposed Risk Class|
|High intensity electromagnetic radiation emitting equipment intended for use on the human body for hair removal only||Class IIa|
|High intensity electromagnetic radiation emitting equipment for use on the human body for skin treatment||Class IIb|
|Equipment intended to reduce, remove or destroy adipose tissue (body fat)||Class IIb|
|Equipment intended for brain stimulation, applying electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain||Class III|
According to the Commission, the reason for the reclassification of these products is to ensure that their classification reflects the related risks that they present and that they are subject to the same pre-and post-market requirements as medical devices presenting a comparable risk and falling within the same classification.
As products falling within Class I, the conformity assessment of products listed in Annex XVI was by self-assessment with no or limited involvement of third parties such as notified bodies. The new risk category classifications proposed by the draft implementing regulation would change the applicable conformity assessment procedure for some of these products. This would include requiring that the manufacturer to involve a notified body.
The draft implementing regulation does not include any transitional provisions. This means that, if the draft implementing regulation is adopted and enters into application towards the end of 2022 it will immediately apply to the products falling within its scope. In light of the existing over-subscription and related delays that notified bodies and manufacturers are facing it may be challenging for manufacturers of products falling within the scope of the draft implementing regulation to identify a notified body and conduct the conformity assessment before the regulation enters into force, meaning that they may be prevented from continuing to place their products on the EU market after this time.
The draft implementing regulation is currently open for stakeholder feedback here until 8 September 2022. Please do not hesitate to contact a member of the Cooley team if you have any questions or are interested in participating in the consultation.