EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down common specifications for the groups of products without an intended 
medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European 
Parliament and of the Council on medical devices  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down common specifications for the groups of products without an intended 
medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European 
Parliament and of the Council on medical devices  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regul ation (EU) 2017/745 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  1(2), in conjunction with  Article  9(1), thereof , 
Whereas:  
(1) Regulation (EU) 2017/745 lays down rules concerning the placing on the market, 
making available on the market or putting into service of medical devices for human 
use and accessories for such devices in the Union. Regulation (EU) 2017/745 further 
requires the Commission to adopt for groups of products without an intended medical 
purpose  listed in its Annex XVI , common specifications addressing, at least, 
application of risk management as set out in the general safety and performance 
requirements laid down  in Annex I to that Regulat ion and, where necessary, clinical 
evaluation regarding safety . 
(2) From the date of application of the common specifications,  Regulation (EU) 2017/745 
is to apply  also to those groups of products  without an intended medical purpose . 
(3) In order for manufacturers  to be able to demonstrate the conformity of products  
without an intended medical purpose  with regard to application of risk management , 
the common specifications should cover  the application of risk management as set out 
in the second sentence of Section 1 and in sections from  2 to 5, 8 and 9  of Annex I to 
Regulation (EU) 2017/745 . Consequently, in accordance with Article 9(2) of 
Regulation (EU) 2017/745, products  without an intended medical purpose that are in 
conformity with th e common specifications are to be presumed to be in conformity 
with the requirements set out  in those provisions.  
(4) The common specifications  should in principle be laid down  for all groups of products 
without an intended medical purpose listed in Annex XVI of Regulation (EU) 
2017/745 . However , as Regulation (EU) 2017/745  regulates the placing on the market, 
making available on the market or putting into service  in the Union , common 
specifications are not needed for  products for which there is no information available 
about them being marketed in the Union . For example, there is no information on the 
following products being marketed in the Union : contact lenses containing tools, such 
as antenna or microchip, contact lenses which are active devices ; active implantable 
                                                 
1 OJ L 117 , 5.5.2017, p. 1 . EN 2  EN products intended to be totally or partially introduced into the human body through 
surgically invasive means for the purpose of modifying the anatomy  or fixing a part of 
the body; active  devices  intended to be used for facial or other dermal or mucous 
membrane filling by s ubcutaneous, submucous or intradermal injection or other 
introduction ; active implantable equipment intended to be used to reduce, remove or 
destroy adipose tissue . In addition, for some products  the information available is  not 
sufficient to allow the Com mission to draw up common specification s. That is for 
example the case for  some other items intended to be introduced into or onto the eye  
and for sunbeds . 
(5) Equipment using infrared optical radiation to warm the body or parts of the body  
intended for treatm ent of  tissues or parts of the body under the skin  should not be 
considered products for skin treatment purposes . Consequently , they should not be 
covered by this Regulation.  
(6) As the group  of products  listed in point  6 of Annex XVI to Regulation (EU) 2017/745 
is intended for  brain stimulation where only electrical currents or magnetic or 
electromagnetic fields penetrate the cranium , invasive devices  intended for brain 
stimulation , such as electrodes or sensors that are partially or tot ally introduced into 
the human body , should not be covered by this Regulation.  
(7) Regulation (EU) 2017/745  requires  a product  without a medical purpose listed in 
Annex XVI to that Regulation, when used under the conditions and for the purposes 
intended , to present no risks at all or present a risk that is no more than the maximum 
acceptable risk related to the product’s use which is consistent with a high level of 
protection for the safety and health o f persons.  
(8) The g roups of products  without an intended medic al purpose listed in Annex XVI to 
Regulation (EU) 2017/745  cover a wide variety of devices for different applications 
and intended uses. A common methodology for risk management should be drawn up 
to ensure a harmonised approach by manufacturers of different groups of devices  and 
to facilitate a coherent implementation of the common specifications . 
(9) In order to ensure appropriate risk management, it is necessary to identif y specific risk 
factors to be analysed and minimised and  to identify  specific risk control measures to 
be implemented with respect to e ach group of devices listed in Annex XVI to 
Regulation (EU) 2017/745.  
(10) In order to facilitate the implementation of risk management  by manufacturers of both 
medical devices and product s without an intended medical purpose  risk management 
for both groups of products should be based on the same  harmonised principles and 
the requirements  should be compatible . The rules on the application of  risk 
management should  therefore  be in line with well-established international guidance in 
the field, including  the international standard ISO 14971:2019 on application of risk 
management to medical devices . 
(11) Regulation (EU) 2017/745 provides  that the clinical evaluation of products without an 
intended medical purpose are to  be based on relevant clinical data concerning 
performance and safety . Such data are to  includ e information from post -market 
surveillance, post -market clinical follow -up, and, whe re applicable, specific clinical 
investigation. As in general it is not possible to demonstrate e quivalence between a 
medical device and a product without an intended medical purpose , where all available 
results on  clinical investigations relate to medical  devices  only, clinical investigations 
should be performed for products without an intended medical purpose.  EN 3  EN (12) Where clinical investigations have to  be performed  to confirm the conformity with the 
relevant general safety and performance requirements , it is n ot possible to complete 
the clinical investigations and the conformity assessment within six months. For such 
cases transitional arrangements should be laid down . 
(13) Where a notified body has to be involved in the conformity assessment procedure, it is 
not po ssible for the manufacturer to complete the conformity assessment within six 
months. For such cases transitional arrangement s should be laid down . 
(14) In order to ensure the product safety  during the transitional period, it should be 
allowed to continue to place the products on the market and to make them available on 
the market  or put them into service , provided t hat the product s in question were 
already lawfully market ed in the Union  before the date of  application  of this 
Regulation , that they  continue to comply with the requirements of Union and national 
law applicable before the date of  application  of this Regulation and  that their design 
and intended purpose are not significantly change d. As the purpose of putting in place 
the transitional arrangements  is to allow the manufacturers enough time to conduct the 
required clinical investigations and conformity assessment procedures, the transitional 
arrangements should cease where  manufacturers do not proceed with the clinical 
investigations or conformity ass essment  procedure , as applicable,  within a reasonable 
timeframe . 
(15) The Medical Device Coordination Group has been consulted.  
(16) The application date of this  Regulation should be deferred as provided for in 
Regulation (EU) 2017/745 . 
(17) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee  on Medical Devices , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Common specifications  
1. This Regulation lays down common specifications for the groups of products without 
an intended medical purp ose listed in Annex XVI to Regulation (EU) 2017/745 . 
Annex I lays down common specifications for all th ose groups of products without 
an intended medical purpose . 
Annex II lays down common specifications for contact lenses as specified in Section 
1 of that Annex . 
Annex II I lays down common specifications for products intended to be totally or 
partially introduced into the human body through surgically invasive means for the 
purpose of modifying the anatomy , with the exception of tattooing products and 
piercings,  as specified in Section 1 of that Annex . 
Annex I V lays down common specifications for substances, combinations of 
substances, or items intended to be used for facial or other dermal or mucous 
membrane filling by subcutaneous, submucous or intrade rmal injection or other 
introduction , excluding those for tattooing,  as specified in Section 1 of that Annex . 
Annex V lays down common specifications for  equipment intended to be used to 
reduce, remove or destroy adipose tissue, such as equipment for lipos uction, lipolysis 
or lipoplasty  as specified in Section 1 of that Annex . EN 4  EN Annex V I lays down common specifications for  high intensity electromagnetic 
radiation (for example,  infra -red, visible light and ultra -violet) emitting equipment 
intended for use on the human body, including coherent and non -coherent sources, 
monochromatic and broad spectrum, such as lasers and intense pulsed light 
equipment, for skin resurfacing, tatto o or hair removal or other skin treatment  as 
specified in Section 1 of that Annex . 
Annex V II lays down common specifications for equipment intended for brain 
stimulation that apply electrical currents or magnetic or electromagnetic fields that 
penetrate th e cranium to modify neuronal activity in the brain as specified in Section 
1 of that Annex.  
2. The common specifications  laid down in this Regulation  cover  the requirements set 
out in  the second sentence of  Section 1  and in Sections 2 to 5, 8 and 9 of Annex I  to 
Regulation (EU) 2017/745.  
Article 2  
Transitional provisions  
1. A product for which clinical investigations have  to be performed in accordance with 
Article 61 of Regulation (EU) 2017/745 , in order to confirm  its conformity with the 
relevant general safety and performance requirements set out in Annex I to 
Regulation (EU) 2017/745  and the common specifications set out in this Regulation , 
may be placed on the market , made available on the market  and put into servic e until 
… [OP please insert the date  – 3 years after the date of application of this 
Regulation ], provided that  the following conditions are met:  
(a) the product was already lawfully market ed in the Union  before … [OP please 
insert the date – date of application of this Regulation ] and continue s to 
comply with the requirements  of Union and national law that were applicable 
to it before … [OP please insert the date – date of application  of this 
Regulation ]; 
(b) there are no significant changes in t he design and intended purpose  of the 
product . 
By way of derogation from the first subparagraph  of this paragraph , from … [ OP 
please insert the date – 6 months  after the date of application of this Regulation ] until 
… [OP please insert the date – 1 year after the date of application of this Regulation ] 
the manufacturer may only place on the market or put into service the products that 
meet the conditions laid down in that sub paragraph , if the sponsor has submit ted an 
application for the clinical inv estigations of the product in accordance with Article 
70(1) of Regulation (EU) 2017/745.  
By way of derogation from the first subparagraph  of this paragraph , from … [ OP 
please insert the date – 1 year and 1 day  after the date of application of this 
Regulati on] until … [ OP please insert the date – 18 months  after the date of 
application of this Regulation ], the manufacturer may only place on the market or put 
into service the products that meet the conditions laid down in that sub paragraph, if 
the sponsor has  received from the Member State concerned a notification confirming 
that the application referred to in th e second  subparagraph  of this paragraph  is 
complete and that the clinical investigation falls within the scope of the Regulation 
(EU) 2017/745 . EN 5  EN By way  of derogation from the first subparagraph, from … [ OP please insert the date 
– 18 months and 1 day  after the date of application of this Regulation ] until … [ OP 
please insert the date – 3 years after the date of application of this Regulation ], the 
manufacturer may only place on the market or put into service the products that meet 
the conditions laid down in that sub paragraph, if the sponsor has start ed the clinical  
investigation.   
2. A product for which clinical investigation s do not have  to be performed  in 
accordance with Article 61 of Regulation (EU) 2017/745 , but  in the conformity 
assessment of which  a notified body has to  be involved  in accordance with Article 52 
of that Regulation , may be placed on the market, made available on the market and 
put into service until … [OP please insert the date  – 1 year  after the date of 
application of this Regulation ], provided that  the following conditions  are met : 
(a) the product  was already lawfully marketed in the Union  before … [OP please 
insert the date  of application of this Regulation ] and continue s to comply with 
the requirements  of Union and national law  that were applicable to it before … 
[OP please insert the date of application of this Regulation ]; 
(b) there are no significant changes in the design an d intended purpose of the 
product . 
By way of derogation from the first subparagraph, from … [ OP please insert the date 
– 3 months after the date of application of this Regulation ] until … [ OP please insert 
the date – 1 year after the date of application of  this Regulation ], the manufacturer 
may only place on the market or put into service the products that meet the 
conditions laid down in that subparagraph, if a written agreement for the 
performance of the conformity assessment has been signed by the notifi ed body and 
the manufacturer.  
3. A product for which clinical investigations do not have  to be performed  in 
accordance with Article 61 of Regulation (EU) 2017/745, but  in the conformity 
assessment of which a notified body has to be involved  in accordance with  Article 52 
of that Regulation  and the notified body must seek a scientific opinion in accordance 
with Article 52(9) of that Regulation,  may be placed on the market, made available 
on the market and put into service until … [OP please insert the date – 18 months  
after the date of application of this Regulation ], provided that the product meets the 
conditions  laid down in paragraph 2, first subparagraph,  points (a) and (b). 
By way of de rogation from the first subparagraph , from … [OP please insert the date 
– 3 months after the date of application of this Regulation] until … [OP please insert 
the date – 18 months  after the date of application of this Regulation] , the 
manufacturers may place on the market or  put into service the products that meet the 
conditions laid down in that subparagraph, if a written agreement for the 
performance of the conformity assessment has been signed by the notified body and 
the manufacture r.  
Article  3 
Entry into force and date of application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . EN 6  EN It shall apply from … [OP please insert the date – 6 months after the date of entry into force 
of this Regulation ]. 
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 DER LEYEN