The new draft act available on the website of the European Commission aims at regulating active products without an intended medical purpose falling under Annex XVI of Regulation (EU) 2017/745 – EU MDR. Particularly, the draft Commission Implementing Regulation will ensure a risk-approach product classification based on the inherent risks and potential side effects of these products.
Stakeholders are invited to take part into this initiative by giving feedback within the 4 weeks period going from August 11, 2022, to September 08, 2022 (midnight Brussels time).
Products falling under Annex XVI of Regulation (EU) 2017/745
According to Article 1(2) of Regulation (EU) 2017/745, the EU MDR shall also apply to the groups of products without an intended medical purpose listed in Annex XVI, taking into account the date of application of common specifications (CS) adopted pursuant to Article 9, i.e., 6 months after their publication.
Among the products without an intended medical purpose appear:
- Contact lenses or other products intended to be introduced into or onto the eye;
- Surgically invasive products intended to modify the anatomy or fixation of body parts;
- Substances, combination of substances, or items intended for facial or other dermal or mucous membrane filling;
- High intensity electromagnetic radiation emitting equipment intended to be used on the human body, such as laser or intense pulsed light devices for hair removal or skin treatment;
- Devices intended to reduce, remove, or destroy adipose tissue, such as liposuction equipment;
- Brain stimulation devices intended to modify neuronal activity in the brain.
The draft act: how will the classification change?
According to Article 1 of the draft act, the classification of active products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745, shall apply as follows:
- High intensity electromagnetic radiation emitting equipment intended to be used on the human body for hair removal only, is reclassified as class IIa;
- Examples: Lasers 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.
- High intensity electromagnetic radiation emitting equipment intended to be used on the human body for skin treatment, is reclassified as class IIb;
- Examples: Laser 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.
- Devices intended to reduce, remove, or destroy adipose tissue, such as liposuction equipment, is reclassified as class IIb;
- Further examples: Radiofrequency lipolysis, ultrasound lipolysis, cryolipolyisis, laser lipolysis, infrared and electrical stimulation lipolysis, acoustic shockwave therapy or lipoplasty.
- Brain stimulation devices applying electrical currents or magnetic or electromagnetic fields intended to modify neuronal activity in the brain, is reclassified as class III.
- Examples: Equipment for transcranial magnetic stimulation or transcranial electric stimulation.
Feedback on the draft act will be published on the European Commission’s website and considered for the final version. The implementing Regulation will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Have a look at our Library of Documents – MDR European Commission – to read the full text.
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