Informative Note

Medical Devices: Reclassification of groups of products with a non-medical intended purpose

19/08/2022
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The entry into force on 26 May 2021 of Regulation (EU) No 2017/745 of the European Parliament and of the Council on Medical Devices (“MDR”) has brought about a significant change in the regulatory framework applicable to these devices.

The MDR applies to products with a non-medical purpose and a list of these products is set out in Annex XVI to the MDR. As a result, certain groups of products for which the manufacturer only claims a non-medical intended purpose, but which are similar to medical devices in terms of functioning and risk profile, fall under the scope of the MDR.

Under the MDR, medical devices are placed in risk classes I, IIa, IIb and III, according to their intended purpose and the risks inherent to their use. This classification is carried out in accordance with Annex VIII of the MDR, which establishes the classification rules.

The MDR also provides that, after consulting the Medical Device Coordination Group, the European Commission may - by way of derogation from Annex VIII of the Regulation and for reasons of public health - reclassify a device, category or group of devices. This reclassification is based on new scientific evidence or any information that becomes available in the course of the market vigilance and surveillance activities.

Therefore, at the request of some Member States, the European Commission is preparing an Implementing Regulation for this legislation. This will provide for the reclassification of certain groups of products which, in light of current knowledge, need to be reclassified in terms of risk category.

Therefore, if this proposal for an Implementing Regulation becomes definitive, the following products, which have been classified as Class I up to now, will be classified as follows:

  • Equipment emitting high intensity electromagnetic radiation intended for use on the human body for hair removal – Class IIa
  • Equipment emitting electromagnetic radiation of high intensity intended to be used on the human body for skin treatment – Class IIb
  • Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty - Class IIb
  • Equipment for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain - Class III

This initiative is now in the public consultation phase for the submission of comments, and any citizen can contribute. These comments must be submitted by 8 September 2022.

This initiative is expected to be adopted in the third quarter of 2022 and the Implementing Regulation will enter into force 20 days after its publication.

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