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European Commission publishes draft implementing regulation to reclassify non-medical active products

Published by Alec Denniff, Medical Device Paralegal on

The European Commission has published an initiative to ensure that active products without a medical purpose, which are covered by the EU Medical Devices Regulation, are appropriately classified based on their risk. In reclassifying these active products, the initiative will ensure that these products are subject to the same pre- and post-market requirements as comparable active medical devices. 

By virtue of Article 1 (2) of the EU MDR, European rules regulating medical devices also apply to the category of non-medical active products listed in Annex XVI to the regulations. Amongst other products, the category includes:

  • Contact lenses and other items which are intended to be introduced into or onto the eye;
  • Laser or intense pulsed light devices for hair removal or skin treatment;
  • Liposuction equipment
  • Brain stimulation devices. 

The application of European rules on medical devices to these active products is largely a reflection of their risk profile. The initiative was born out of Member State concern that the classification rules laid down in Annex VIII to the regulations do not ensure an appropriate level of pre-market regulatory control. As a result, the Commission has published the draft rules as a means of derogating from the classification rules. This is both to ensure these active products are appropriately classified proportionate to their risk, and for consistency with the rationale for including these products within the scope of the regulations.

As is made explicitly clear by Section 3.1 Chapter II Annex VIII to the regulations, the application of the classification rules is to be governed by the intended purpose of the device. As the classification rules for active medical devices in Rules 9-10 of the regulations refer to a specific medical purpose (e.g. therapy, diagnosis), these rules cannot be applied to the category of products listed in Annex XVI because these active products do not have an intended medical purpose. If classified by the Annex VIII rules, such products would be classified as Class I in accordance with Rule 13, covering all other active devices. This issue represents the crux of the Member State concern. 

So how are the active non-medical products to be classified? The Commission has drafted the following reclassifications, which are in derogation from the Class I default rule for active devices in Rule 13 of Annex VIII:

  • High intensity electromagnetic radiation-emitting equipment for use on the human body, which is intended for hair removal only, is to be reclassified as Class IIa. 
  • Other high intensity electromagnetic radiation-emitting equipment for use on the human body, which is intended for skin treatment, including tattoo removal, is reclassified as Class IIb.
  • Equipment intended to be used to reduce, remove or destroy adipose tissue, is reclassified as Class IIb.
  • Equipment to be used for brain stimulation, which apply electrical currents or magnetic or electromagnetic fields which penetrate the cranium to modify neuronal activity in the brain, are to be classified as Class III.

The European Commission is currently reviewing feedback to the draft initiative, with adoption planned over the next few months. The reclassification will result in a heavy regulatory burden for manufacturers producing these products. It will result in changes to the applicable conformity assessment procedure for some of these products, and would require that the manufacturer contact an EU Notified Body to carry out the relevant conformity assessment. The draft implementing regulation does not currently include any transitional periods. This means that, should the draft implementing regulation enter into force as it currently stands, it will immediately apply to the products falling within the scope. 

This position is worsened by the existing delays that Notified Bodies and manufacturers are facing. It could be challenging for manufacturers of products falling within the scope of the draft regulation to identify and contract a competent Notified Body to carry out the relevant conformity assessment before the regulation comes into effect. This could mean manufacturers are prevented from being able to continue to place their products on the EU market after the entry into force of the regulation. 

If you are interested in learning more about these reclassification changes and how they may affect the classification of your device, please reach out to any member of the team. Please also register your interest in our AI-powered guide to the medical devices regulations, below. Our guided assessment incorporates all official updates to the regulations, and will be able to guide you through the regulatory maze.