EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down rules for the application of Regulation (EU) 2017/745 of the European 
Parliament and of the Council as regards reclassification of groups of certain active 
products without an intended medical purpose    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down rules for the application of Regulation (EU) 2017/745 of the European 
Parliament  and of the Council as regards reclassification of groups of certain active 
products without an intended medical purpose  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) 2017/74 5 of the European Parliament and of the Council of 
5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 
178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC 
and 93/42/EEC1, and in particular Article 51( 3), point (b),  thereof,  
 
Whereas:  
(1) The classification rules 9 and 10 on active devices in Sections 6.1. and 6.2. of Annex 
VIII to Regulation (EU) 2017/745 refer to an intended medical purpose, respectively 
for therapy  and diagnosis,  and thus cannot  be applied to  active products without an 
intended medical purpose  referred to in Article 1(2) of that Regulation . Such products  
are therefore to be classified as  class I in accord ance with rule 13  in Section 6.5. of 
Annex VIII to Regulation (EU) 2017/745 . 
(2) By letter of 28 July 2022 , certain Member States  jointly requested the reclassification 
of several active products without an intended medical purpose by way of derogation 
from Annex VIII to Regulation (EU) 2017/745 , in order to ensure an appropriate 
conformity assessment of those active products that is consistent with their inherent 
risks  before their placing on the market . 
(3) According to a vailable scientific evidence on equipment  that emits high intensity 
electromagnetic radiation , as referred to in Section 5 of Annex XVI to Regulation 
(EU) 2017/745 , intended for use on the human body , such as lasers and intense pulsed 
light (‘IPL’) equipment,  the use of such equipment may cause side effect s, for 
example , superficial burns, inflammat ion, pain, pigmentation change , erythema,  
hypertrophic scarring  and blisters . Side effects are often indicated as transient , for 
example,  inflammations, but important and long -lasting effects are also reported , such 
as skin pigmentation changes.  
(4) High inten sity electromagnetic radiation emitting equipment without an intended 
medical purpose,  intended for use on the human body  for hair removal , such as lasers 
and IPL equipment  that administer  energy to  or exchange energy with the human body 
or supply energy t hat will be absorbed by the human body , should therefore be 
classified as class IIa . Such classification also corresponds to classification of 
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 . 
                                                 
1 OJ L 117, 5.5.2017, p.1.   
EN 2  EN (5) High intensity electromagnetic radiation emitting equipment without an intended 
medical purpose,  intended for the use on the human body for skin treatment, such as 
laser or IPL equipment  for skin resurfacing, for scar removal, for tattoo removal, or for 
treatment of nevi flamme i, 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 , should therefore be 
classified as class IIb . Such classification also corresponds to classification of 
analogou s 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 . 
(6) According to available scientific evidence on equipment intended to be used to reduce, 
remove or destroy adipose tissue, as referred to in Section 4 of Annex XVI to 
Regulation (EU) 2017/745 , such as equipment for liposuction, radiofrequency 
lipolysis , ultrasound lipolysis, cryolipolyisis, laser lipolys is, infrared and electrical 
stimulation lipolysis, acoustic shockwave therapy  or lipoplasty , the use of such 
products may cause side effect s, for example , local inflammation, erythema, bruising  
and swelling . Side effects are often indicated as transient , but important and long -
lasting effects are also reported , such as  paradoxical adipose hyperplasia after 
cryolipolysis treatment . Those products should therefore be classified as class IIb . 
Such classification also corresponds to classification of active the rapeutic 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.  
(7) According to available s cientific evidence on e quipment intended for brain stimulation 
that apply electrical currents or magneti c or electromagnetic fields that penetrate the 
cranium to modify neuronal activity in the brain  as referred to in Section 6 of Annex 
XVI to Regulation (EU) 2017/745 , such as those for transcranial 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 irri tation at the electrode site . While such equipment is not 
surgically invasive, the electrical currents or magnetic or electromagnetic fields do 
penetrate the cranium to modify neuronal activity in the brain. Such modifications can 
have long -lasting effects  and any unintended effects may be difficult to reverse.  Such 
products  should therefore be classified as Class III . 
(8) As a result of reclassification under this Regulation, in accordance with Article 5 2 of 
Regulation (EU) 2017/745, a notified body is to  be involved in the conformity 
assessment of the  products  concerned , to assess and confirm that, among the relevant 
general safety and performance requirements,  the product achieves the intended 
performance and that the risks posed by the product ha ve been eliminated or reduced 
as far as possible . 
(9) The Medical Device Coordination Group has been consulted . 
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee on Medical Devices,   
EN 3  EN HAS ADOPTED THIS REGULATION:  
 
Article 1 
By way of derogation from  Section 6.5 of Annex VIII to Regulation (EU) 2017/745, the 
following groups of active products without an intended medical purpose listed in Annex XVI  
to that Regulation are reclassified as  follows : 
(a) high intensity electroma gnetic radiation emitting equipment  as referred to in Section 
5 of Annex XVI to Regulation (EU) 2017/745  that is intended for the use on the 
human body for hair removal  only is reclassified as class IIa ; 
(b) high intensity electromagnetic radiation emitting eq uipment as referred to in Section 
5 of Annex XVI to Regulation (EU) 2017/745 that is intended for the use on the 
human body for skin treatment  is reclassified as class IIb ; 
(c) equipment intended to be used to reduce, remove or destroy adipose tissue  as 
referred to in Section 4 of Annex XVI to Regulation (EU) 2017/745 , is reclassified as 
class IIb ; 
(d) equipment intended for brain stimulation that apply electrical currents or magnetic or 
electromagnetic fields that penetrate the cranium to modify neuronal  activity in the 
brain  as referred to in Section 6 of Annex XVI to Regulation (EU) 2017/745 is 
reclassified as class III . 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von d er Leyen