Reclassification of Certain Active Products without a Medical Intended Purpose

On 2 December 2022, Commission Implementing Regulation (EU) 2022/2347 on the “reclassification of groups of certain active products without an intended medical purpose” was published in the Official Journal of the European Union (OJEU). This concise bit of legislation may have a dramatic impact on the conformity assessment of Annex XVI products under the EU medical device regulation 2017/745 (MDR).

The main issue with the application of Annex VIII Rules is that they are specific to medical devices and not to those without an intended medical purpose. This poses a problem for manufacturers of products under Annex XVI who have found it difficult to assign an appropriate risk classification. The “default” rules 9 and 10 of Annex VIII refer to an intended medical purpose, which automatically disqualifies the products listed in Annex XVI.

However, Implementing Regulation 2022/2347 aims to fix this following a letter early this year for the consideration to reclassify several active products without an intended medical purpose. The results are:

Device TypeIntended UseExamplesClassification
High intensity electromagnetic radiation emitting equipmentIntended for use on the human body for hair removalLasers and IPL equipment that administer energy to or exchange energy with the human body or supply energy that will be absorbed by the human body.

Also applies to analogous active devices that have an intended medical purpose and whose functioning and risks profile are similar to those of the equipment without an intended medical purpose in question.
Class IIa
High intensity electromagnetic radiation emitting equipmentIntended for the use on the human body for skin treatmentLaser or IPL equipment for skin resurfacing, for scar removal, for tattoo removal, or for treatment of nevi flammei, haemangioma, telangiectasia and pigmented skin areas that administer energy to or exchange energy with the human body or supply energy that will be absorbed by the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy.

Also applies to analogous active devices that have an intended medical purpose and whose functioning and risks profile are similar to those of the equipment without an intended medical purpose in question.
Class IIb
EquipmentIntended to be used to reduce, remove or destroy adipose tissueEquipment for liposuction, radiofrequency lipolysis, ultrasound lipolysis, cryolipolyisis, laser lipolysis, infrared and electrical stimulation lipolysis, acoustic shockwave therapy or lipoplasty, the use of such products may cause side effects, for example, local inflammation, erythema, bruising and swelling.

Also applies to active therapeutic devices whose functioning and risks profile are similar to those of the equipment without an intended medical purpose in question, intended to administer energy to or exchange energy with the human body or supply energy that will be absorbed by the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy.
Class IIb
EquipmentIntended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brainTranscranial magnetic stimulation or transcranial electric stimulation, the use of such products may cause side effects, for example, atypical brain development, abnormal patterns of brain activity, increase metabolic consumption, fatigue, anxiety, irritability, headaches, muscle twitches, tics, seizures, vertigo and skin irritation at the electrode site.Class III

You can read the Implementing Regulation here.