EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing of Directive 2014/53/EU of the European Parliament and of the Council 
with regard to the application of the essential requirements for radio equipment 
referred to in Article 3(3), points (d), (e) and (f), of that Directive  
(Text with EEA rele vance)   EN 1  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing of Directive 2014/53/EU of the European Parliament and of the Council 
with regard to the application of the essential requirements for radio equipment 
referred to in Article 3(3), points (d), (e) and (f), of that Directive  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Unio n, 
Having regard to Directive 2014/53/EU of the European Parliament and of the Council of 16 
April 2014 on the harmonisation of the laws of the Member States relating to the making 
available on the market of radio equipment and repealing Directive 1999/5/E C1, and in 
particular Article 3(3), the second subparagraph, in conjunction with Article 3(3),  first 
subparagraph,  points (d), (e) and (f),  thereof,  
Whereas:  
(1) Protection of the network or its functioning from harm, protection of personal data and 
privacy of  the user and of the subscriber and protection from fraud are elements that 
support protection against  cybersecurity risks . 
(2) As stated in recital 13 of Directive 2014/53/EU, the protection of personal data and 
privacy of users and of subscribers of radio equipment and the protection from fraud 
may be enhanced by particular features of radio equipment. According to that recital , 
radio equipment should  therefore in appropriate cases  be designed in such a way that it 
supports those features.  
(3) 5G will play a key role in the development of the Union digital economy and society 
in the years to come and will potentially affect almost every aspect of Union citizens' 
lives. The document with title ‘Cybersecurity of 5G networks EU Toolbox  of risk 
mitigating measures’2 identifies  a possible common set of measures which are able to 
mitigate the main cybersec urity risks of 5G networks and  provide s guidance for the 
selection of measures which should be prioritised in mitigation plans at national and at 
Union level.  In addition to those measures, i t is very importan t to follow  a harmonised 
approach to essential requirements relating to elements of cybersecurity protection 
applicable to 5G radio equipment when it is placed on the Union market . 
(4) The level of security applicable under Union essential requirements set out in Article 
3(3)(d), (e) and (f) to ensure network  protection , safeguards for the protection of 
                                                 
1OJ L 153, 22.5.2014, p. 62.  
2Cybersecurity of 5G networks - EU Toolbox of risk mitigating measures, 29 January 2020. 
https://ec.europa.eu/digital -singlemarket/en/nis -cooperation -group  EN 2  EN personal data and privacy and protection from fraud  shall not undermine the high level 
of security requeste d at national level for decentralised  smart grids  in the field of 
energy where smart meters subject to those requirements are to be used , and for 5G  
network  equipment used by providers of public electronic communications networks 
and publicly avail able electronic communications services within the meaning of  in 
Directive (EU) 2018/1972.  
(5) Numerous concerns have also been expressed in relation to increasing cybersecurity 
risks as a result of the increased use by professionals and consumers, including 
children, of  radio equipment which: (i) is capable itself to communicate over the 
internet, regardless if it communicates directly or via any other equipment (‘internet -
connected radio equipment ’), i.e., such internet -connected equipment  operates  
protocols necessary to exchange data with  the internet either directly or by means of 
an intermediate equipment ; (ii) can be either a toy with radio function which also falls 
within the scope of  Directive 2009/48/EC  of the European Parliament and of the 
Council3 or is designed  or intended exclusively for childcare , such as child monitors ; 
or (iii) is designed or  intended , whether exclusively or not exclusively,  to be worn on, 
strapped to, or hung from any part of the human body (including the head, neck, trunk, 
arms,  hands, legs and feet) or any clothing (including headwear, hand wear and 
footwear) worn by human beings such as radio equipment in the form of wrist watch, 
ring, wristband, headset, earphone or glasses (‘wearable radio equipment’ ).  
(6) In this respect , any radio equipment  for childcare , radio equipment covered by 
Directive  2009/48/EC  or wearable radio equipment , which is capable itself to 
communicate over the internet, regardless if it communicate s directly or via any other 
equipment, should be  deemed to be internet -connected radio equipment . Implants , for 
example,  should not be considered as wearable radio equipment  as they are not  worn 
on, strapped to, or hung from any part of the human body or any clothing . However, 
implants  should be deemed to be internet -connected radio equipment , if they are 
capable themselves to communicate over the internet, regardless if they communicate 
directly or via any other equipment . 
(7) Given the concerns raised due to the fact that radio equipment does not ensure 
protection against  elements of cybersecurity risks, it is necessary to render applicable, 
for radio equipment within certain categories or classes, the essential requirements of 
Directive 2014/53/EU associated with the protection from harm to the network, 
protection of perso nal data and privacy of users and of subscribers and protection from 
fraud.  
(8) Directive 2014/53/EU applies to products that meet the definition of ‘ radio equipment ’ 
in Article 2 of that Directive, subject to specific exclusions specified in Article 1(2) 
and Article 1 (3) of that Directive. Whilst the definition of radio equipment in Article 2 
of Directive 2014/53/EU refers to equipment  that can communicate  with radio waves, 
no requirements of Directive 2014/53/EU make a distinction between the radio and 
                                                 
3 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys  (OJ 
L 170, 30.6.2009, p.1).  EN 3  EN non-radio functions of the radio equipment  and therefore all aspects and parts of the 
equipment should comply with the essential requirements provided for in this 
delegated regulation .  
(9) As regards harm to the network or its functioning or misuse of network reso urces, 
unacceptable degradation of services can be caused by internet -connected radio 
equipment which do not ensure that networks are not harmed or are not misused. For 
example, an attacker may maliciously flood the internet network to prevent legitimate 
network traffic, disrupt the connections between two radio products, thus preventing 
access to a service, prevent a particular person from accessing a service, disrupt a 
service to a specific system or person or disrupt information. The degradation of 
onlin e services can thus result in malicious cyber -attacks, which will lead to increased 
costs, inconveniences or risks for operators, service providers or users. Article 3(3) , 
point (d),  of Directive 2014/53/EU, which requires that radio equipment does not har m 
the network or its functioning nor misuse network resources, thereby causing an 
unacceptable degradation of service , should therefore apply to internet -connected 
radio equipment . 
(10) Concerns  have also been raised as regards the protection of personal data a nd privacy  
of the user  and of the subscriber  of internet -connected radio equipment  due to the 
ability of that radio equipment  to record, store and share information, interact with the 
user, including children, when speakers, microphones and other sensors a re integrated 
in that radio equipment . Those  concerns relate , in particular to the ability of th at radio 
equipment  to record photos, videos, localisation data, data linked to the play 
experience as well as heartrate, sleeping habits or other personal data.  For instance, 
advanced settings of the radio equipment  can be accessed through a default password 
if the connection or the data are not encrypted or if a strong authentication mechanism 
is not in place . 
(11) It is thus important that i nternet -connected radio e quipment , which is placed on the 
Union market, incorporate safeguards to ensure that personal data and privacy  are 
protected  when they are capable of processing personal data as defined in Article 4(1) 
of Regulation (EU) 2016/6794 or data defined in Article 2, points (b) and (c) , of 
Directive 2002/58/EC5. Article 3(3) , point (e),  of Directive 2014/53/EU should 
therefore apply to internet -connected radio equipment . 
(12) Additionally, as regards  the protection of personal data and privacy,  radio equipment  
for childcare , radio equipment covered by Directive  2009/48/EC  and wearable radio 
equipment  pose security risks even in the absence of an internet connection. Personal 
                                                 
4 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of 
natural persons with regard to the processing of personal data and on the free movement of such data, and 
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1) .  
5Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing 
of personal data and the protection of privacy in the electronic communications sector (Directive on privacy 
and electronic communications)  (OJ L 201, 31.7.2002, p. 37 ).  
 
 EN 4  EN data can be intercepted when  that radio  equipment  emit or receive radio waves and 
lack saf eguards that ensure persona l data and privacy protection. Th e radio equipment  
for childcare , the radio equipment covered by Directive  2009/48/EC  and the wearable 
radio equipment  can monitor and register a number of the user’s  sensitive (personal) 
data over time and retransmit them through communication technologies that might be 
insecure. The radio equipment  for childcare , the radio equipment covered by Directive  
2009/48/EC  and the wearable radio equipment  should also ensure protection of 
personal data and privacy, when they are capable of processing , within the meaning of 
Article 4(2) of Regulation (EU) 2016/679 , of personal  data, as defined in Article 4(1) 
of Regulation (EU) 2016/679 , or traffic data and location data,  as defined in Article 2, 
points (b) and (c), of  Directive 2002/58/EC . Article 3(3) , point (e),  of Directive 
2014/53/EU should  therefore  apply to that radio equipment . 
(13) As regards fraud, information including personal data can be stolen from internet -
connected radio equipment , which do  not ensure protection  from fraud . Specific kinds 
of frauds concern internet -connected radio equipment  when they are used to perform 
payments over the internet. The costs can be high and do not only concern the person 
who suffered the fraud, but also society as a whole ( for example , the cost of police 
investigation, the costs of victim services, the costs of trials to establish 
responsibilities). It is therefore  necessary  to ensure trustworthy transactions and 
minimise the risk of incurring financial loss of the user s of internet -connected radio 
equipment  executing the payment via that radio equipment  and o f the recipient of the 
payment carried out via that radio equipment . 
(14) Internet -connected radio equipment  placed on the Union market should support 
features for ensuring protection from fraud when they enable the holder or user to 
transfer money, monetary va lue or virtual currency as defined in  Article 2, point (d), of  
Directive (EU) 2019/713 of the European Parliament and of the Council6. Article 3(3) , 
point (f),  of Directive 2014/53/EU should therefore apply to that radio equipment . 
(15) Regulation (EU) 2017/745  of the European Parliament and of the Council7 lays down 
rules on medical devices  and Regulation (EU) 2017/746 of the European Parliament 
and of the Council8 lays down rules on in vitro diagnostic medical devices. Both 
Regulation s (EU) 2017/745 and (EU) 2 017/746 address certain elements of 
cybersecurity risks associated with th e risks  addressed by Article 3(3) , points  (d), (e) 
and (f) , of Directive 2014/53/EU. Radio equipment to which  either  of those 
Regulations appl y should therefore not fall within the c ategories  or classes of radio 
                                                 
6 Directive (EU) 2019/713 of the European Parliament and of the Council of 17 April 2019 on combating 
fraud and counterfeiting of non -cash means of payment and replacing Council Framework Decision 
2001/413/JHA ( OJ L 123, 10.5.2 019, p. 18).  
7 Regulation (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/EE C and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1).  
8 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro 
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 
(OJ L 117, 5.5 .2017, p. 176).  EN 5  EN equipment which should comply with the essential requirements set out in Article 
3(3), points (d), (e) and (f) , of Directive 2014/53/EU.  
(16) Regulation (EU) 2019/2144 of the European Parliament and of the Council9 
establishes requirements for the type -approval of vehicles, and of their systems and 
components. In addition, the principal objective of Regulation (EU) 2018/1139 of the 
European Parliament and of the Council10 is to establish and maintain a high uniform 
level of civil aviation safety in the Union. Moreover, Directive (EU) 2019/520 of the 
European Parliament and of the Council11 lays down the conditions for the 
interoperability of electronic road toll systems and for facilitating cross -border 
exchange of inf ormation on the failure to pay road fees in the Union. Regulation s (EU) 
2019/2144  and (EU) 2018/1139 and Directive (EU) 2019/520 address elements of 
cybersecurity risks associated with th e risks  set out in Article 3(3) , points  (e) and (f) , 
of Directive 201 4/53/EU. Radio equipment  to which Regulation s (EU) 2019/2144  and 
(EU) 2018/1139 or Directive (EU) 2019/520 appl y should therefore not fall within the 
categories or classes of radio equipment which should comply with the essential 
requirements set out in Ar ticle 3(3) , points  (e) and (f) , of Directive 2014/53/EU.  
(17) Article 3 of Directive 2014/53/EU provides for  essential requirements  with which 
economic operators shall comply . In order to facilitate conformity assessment with 
those requirements, it provides for  a presumption of conformity for radio equipment 
that complies with voluntary harmonised standards that are adopted in accordance 
with Regulation (EU) No 1025/2012 of the European Parliament and of the Council12 
for the purpose of expressing detailed techni cal specifications of those requirements. 
The specifications will consider and address the level of risks that correspond to the 
                                                 
9 Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on 
type-approval requirements for motor vehicles and their trailers, and systems, components and separate 
technical units intended for such vehicl es, as regards their general safety and the protection of vehicle 
occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament 
and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 
661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 
631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 
1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458 /2011, (EU) No 
65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 
2015/166 (OJ L 325, 16.12.2019, p. 1) . 
10 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common 
rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and 
amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, ( EU) No 996/2010, (EU) No 376/2014 
and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and 
repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the 
Council and Council Regulation ( EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1) .  
11 Directive (EU) 2019/520 of the European Parliament and of the Council of 19 March 2019 on the 
interoperability of electronic road toll systems and facilitating cross -border exchange of information on 
the fail ure to pay road fees in the Union (OJ L 91, 29.3.2019, p. 45).  
12 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliament and of the Council and repealing Council Decision 
87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Co uncil (OJ L 316, 
14.11.2012, p. 12).  EN 6  EN intended use of each category or class of radio equipment concerned by this 
Regulation.  
(18) Economic operators should be provided with a sufficient time to adapt to the 
requirements of  this Regulation . The appli cation of this R egulation should therefor e be 
deferred.  This Regulation is not to prevent economic operators from complying with it 
from the date of its entry into force.  
(19) The Commission has carried out appropriate consultations during the preparatory work 
of the measures set out in this Regulation and has consulted the Expert Group on 
Radio Equipment,   
HAS ADOPTED THIS REGULATION:  
Article 1 
1. The essential requirement set out in Article 3(3) , point (d), of Directive 2014/53/EU shall 
apply to any radio equipment that can communicate itself  over the interne t, whether  it 
communicates d irectly  or via any other equipment  (‘internet -connected radio equipment ’). 
2. The essential requirement set out in Article 3(3) , point (e), of Directive 2014/53/EU shall 
apply to any of the following radio equipment , if that radio equipment is  capable of 
processing , within the meaning of  Article 4(2) of Regulat ion (EU) 2016/679 , personal  data, as 
defined in Article 4(1) of  Regulation (EU) 2016/679 , or traffic data and locati on data , as 
defined in  Article 2, points (b) and (c) , of Directive 2002/58/EC : 
(a) internet -connected radio equipment , other than the equipment referred to in 
points (b), (c) or (d) ;  
(b) radio equipment designed or intended  exclusively for childcare ; 
(c) radio equipment covered by Directive  2009/48/EC ; 
(d) radio equipment  designed or intended, whether exclusively or not 
exclusively, to be worn on, strapped to, or hung from any of the following:  
(i) any part of the human body, including the head, neck, trunk, arms, 
hands, legs and feet;  
(ii) any clothing, including headwear, hand wear and footwear, which is 
worn by human beings;  
3. The essential requirement set out in  Article 3(3) , point (f), of Directive 2014/53/EU shall 
apply to any internet -connected radio equipment , if th at equipment  enable s the holder  or user 
to transfer money, monetary value or virtual currency  as defined in  Article 2 , point (d), of 
Directive (EU ) 2019/713 . 
Article 2 
1. By way of  derogation from Article 1, the essential requirements set out in Article 3(3) , 
points (d), (e) and (f) , of Directive 2014/53/EU shall not apply to  radio equipment to which 
either of the following Union legislation also applies:  
(a) Regulation (EU) 2017/745;  
(b) Regulation (EU) 2017/746.  EN 7  EN 2. By way of  derogation from Article 1(2) and Article 1(3), the essential requirements set out 
in Article 3(3) , points (e) and (f) , of Directive 2014/53/EU shall not apply to radio equipment 
to which any of the following Union legislation also applies:  
(a) Regulation (EU) 2018/1139;  
(b) Regulation (EU) 2019/2144;   
(c) Directive (EU) 2019/520.  
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from …[ OP please insert the date = 30 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  
 