EN    EN 
 EUROPEAN 
COMMISSION  
Brussels, 17.10.2012  
COM(2012) 584 final 
2012/0283 (COD) 
  
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the harmonisation of  the laws of the Member States relating to the making available 
on the market of radio equipment  
(Text with EEA relevance) 
{SWD(2012) 300 final} 
{SWD(2012) 329 final}  
Ref. Ares(2013)147161 - 05/02/2013 
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
• Context, objectives and grounds for the proposal 
The R&TTE Directive, Directive 1999/5/EC of the European Pa rliament and of the Council 
of 9 March 1999 on radio equipment and teleco mmunications terminal equipment and the 
mutual recognition of their conformity, establishes a framework for the placing on the market, free movement and putting into se rvice in the EU of radio equipment and telecommunications 
terminal equipment. The Directive entered into force in 1999 and has been crucial to 
achieving an internal market in this area.  
The Directive includes essential requirements fo r the protection of health and safety, of 
electromagnetic compatibility and for the avoidance of harmful interference. These 
requirements are translated in to technical requirements within non-mandatory harmonised 
standards, as in other ‘New Approach’ legislat ion. The regulatory appro ach is considered to 
remain valid, a fundamental revisi on of the Directive is therefore not nece ssary. Nevertheless, 
experience in the operation of the Directive has highlighted a number of issues to be 
addressed
1. The main objectives of the draft proposal are: 
– To improve the level of compliance with the requirements in the Directive, and 
to increase the confidence of all stake holders in the regulatory framework; 
– To clarify and simplify the Directive, including some limited adaptations of 
scope, so as to facilitate its application and eliminate unnecessary burden for economic operators and public authorities. 
The proposed revision also allows to better in tegrate the Directive with other related EU 
legislation managed by DGConnect, in pa rticular the Radio Spectrum Decision
2. The 
proposed text is bui lt on the alignment of th e Directive with the new legislative framework for 
the marketing of products (NLF), with Regulation No 182/2011 on the Commission’s 
exercise of implementing powers and with th e Treaty on the Functioning of the European 
Union (TFEU).  
The proposal is based on Articles 26 (Internal  Market) and 114 (Approximation of Laws) of 
the TFEU.  
• Existing provisions in the area of the proposal 
The R&TTE Directive fully harmonises the placing on the EU market  of the products 
falling within its scope. Only equipment complying with the requirements of the Directive may be placed on the market, and Member Stat es may not introduce further restrictions 
addressing at national level the same requirements,  namely the protection of health and safety, 
electromagnetic compatibility, and the avoi dance of harmful interference. Other EU 
legislation on environmental aspect s also applies to these products, in particular the Directives 
                                                
 
1 Second Progress Report on the operation of the R&TTE Directive, COM(2010)43 final, of 9.2.2010 
2 Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a 
regulatory framework for radio spectrum policy in the European Community  
EN 3   EN on RoHS3, WEEE4 and Batteries5, as well as implementing measures under the EcoDesign 
Directive6. 
Putting into service and use of  radio equipment is subject to national regulation. When 
exercising this competence, Member States must comply with applicable EU law, in particular: 
– The general framework for spectrum po licy set out in the Radio Spectrum 
Policy Programme
7; 
– General criteria laid down in Direc tive 2002/21/EC (Framework Directive8) 
within the regulatory framewor k for electronic communications; 
– Conditions for authorisations for the use of spectrum laid down in Directive 
2002/20/EC (Authoris ation Directive9) within the regulatory framework for 
electronic communications; 
– Implementing measures under Deci sion 676/2002/EC (Radio Spectrum 
Decision10) harmonising the technical condit ions for the use of certain 
spectrum bands in the EUand that are binding on all Member States. Examples of bands harmonised at EU level include  the bands for GSM, UMTS and short-
range devices; 
– Consistency with the other polic ies and objectives of the Union. 
The proposal is consistent with the principl es of the Commission’ s ‘Smart Regulation’ 
policy
11, with the policy for Europe 2020, in particular as regards the regulatory review 
foreseen within the policy for an Innovation Union12, as well as with the Radio Spectrum 
Policy Programme13. 
The initiative is consistent with the New Legislative Framework package approved in 2008, 
composed of Regulation 765/2008 on accreditation a nd market surveillance and of Decision 
768/2008 establishing a common framework for th e marketing of products. The Decision 
provides (Article 2) that its pr ovisions are to be used when le gislation is drafted or revised. 
                                                 
3 Directive 2002/95/EC on Restriction of Hazardous Substances. 
4 Directive 2002/96/EC on Waste of Electrical and Elect ronic Equipment. 
5 Directive 2006/66/EC on batteries and accumu lators and waste batteries and accumulators. 
6 Directive 2009/125/EC establishing a framework fo r the setting of ecodesign requirements for energy-
related products.   
7 Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 
establishing a multiannual radio spectrum policy programme. 
8 Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common 
regulatory framework for electronic communications  networks and services (Framework Directive) 
9 Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the 
authorisation of electronic communications networks and services (Authorisation Directive)  
10 Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a 
regulatory framework for radio spectrum policy in the European Community (Radio Spectrum 
Decision) 
11 http://ec.europa.eu/governance/be tter_regulation/key_docs_en.htm#_br. 
12 http://ec.europa.eu/research/innovation-union/index_en.cfm, COM(2010) 546 final, Europe 2020 
Flagship Initiative - Innovation Union. 
13 Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 
establishing a multiannual radio spectrum policy programme.  
EN 4   EN 2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
• Consultation of interested parties 
A first public consultation on the operation of  the Directive took place in 2007. Issues 
identified through this consultation were in cluded in the Second Progress Report on the 
operation of the Directive14. 
The Commission conducted a further public co nsultation in 2010 focusing on the impact of 
some of the measures under consideration. Th e Commission received co ntributions from 122 
respondents, including 50 SMEs, 36 other econo mic operators, national authorities, notified 
bodies, and standardisation bodies15.  
• Collection and use of expertise 
During 2009, a external study was conducted on the impact of different options addressing the 
need to improve traceability of  products and their compliance with the requirements in the 
Directive16.  
Overall, there is a high level of consensus and support for ali gning the Directive with the New 
Legislative Framework package and for clarifyi ng and simplifying the Directive. Opinions are 
more divided on the possible intr oduction of a requirement to re gister products prior to their 
placing on the market, and on some measures  for administrative simplification  
3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
• Legal basis 
Articles 26 and 114 TFEU.  
• Subsidiarity and proportionality principles 
Action at EU level is necessary in order to ad apt, clarify or simplify provisions of Internal 
Market legislation in this area. The propos al harmonises essential and administrative 
requirements compliance with which enables a ccess to the EU market, and its advantages 
compared to multiple similar measures by Member States acting individually are clear. 
In accordance with the principle of proportionality, the proposed modifications do not go 
beyond what is necessary to achieve the objecti ves set. The new or mo dified obligations do 
not impose unnecessary burdens an d costs on industry especially on small and medium sized 
                                                 
14 Report from the Commission to the Council and the European Parliament. Second Progress Report on 
the operation of Directive 1999/5/EC, on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity. [C OM/2010/0043 final - Not published in the Official 
Journal] - http://ec.europa.eu/enterprise/sectors/rtte/documents/legislation/review/index_en.htm#h2-2 
15 Summary of the 2010 public consultation on the impact of options under consideration for the revision 
of the R&TTE Directive. May 2011. http://ec.europa .eu/enterprise/sectors/rtte/public-consultation/files-
public-consultation/summary-2010-pc_en.pdf 
16 Impact Assessment concerning a proposed mandatory registration system in the scope of Directive 
1999/5/EC FINAL REPORT 5.10.2009. Technopolis Group -
http://ec.europa.eu/enterprise/sectors/r tte/files/technop-ia-radio-finrep_en.pdf  
EN 5   EN enterprises - or administrations . Where modifications have been  identified as having negative 
impacts, their analysis has made it possible to provide the most proportionate response to the 
problems identified. A number of modifications  concern the improvement of clarity of the 
existing Directive without introducing new requirements. 
• Choice of instrument 
The proposal is to replace current Directive 1999/5 /EC with a new Directive, to be transposed 
by Member States by way of national legal instruments. 
4. BUDGETARY  IMPLICATION 
The proposal is compatible with the current mu ltiannual financial framework: all measures or 
actions included in the proposed directive are consiste nt and compatible with the current and 
the next multiannual financial framework ( 2014 to 2020) as proposed by the Commission. 
The proposal includes the possibility of requiri ng registration of certain categories of radio 
equipment prior to their placing on the market. Were this possibility to come into effect, a database should be put in place and admi nistered by the Comm ission. The available 
estimation of costs includes an investment of €300000 and an annual maintenance cost of 
€30000. 
5. OPTIONAL
 ELEMENTS   
• Simplification and reduction  of administrative costs 
The proposal aims to clarify the application of  the Directive and to eliminate unnecessary 
administrative burden for businesses and admini strations by increasing spectrum flexibility 
and easing administrative procedures  for spectrum use. It is pa rt of the Commission’s rolling 
programme for updating and simplifying acquis communautaire and its Work and Legislative 
Programme under reference 2009/ENTR/021. 
• Review 
The proposal requires the Commission to revi ew the operation of the Directive and report 
thereon 4 years after the entry into force of the Directive a nd every five years thereafter 
• Information from Member States 
Member States shall inform the Commission on th e transposition of the Directive and send to 
the Commission a report on its application thr ee years after the entry into force of the 
Directive and every two years thereafter. 
• European Economic Area 
The proposed act is of relevance to th e EEA and should therefore extend thereto. 
• Detailed explanation of the proposal 
The most significant elements of the proposal fo r a revision of the Directive are the following:  
EN 6   EN 1. Alignment with Decision 768/2008/EC on a common framework for the marketing 
of products: 
– Article 2 includes the definitions se t out in chapter R1 of Decision 
768/2008/EC 
– Articles 10-to-15 include the obligations  of economic operators set out in 
chapter R2 of Decision 768/2008/EC 
– Article 17 and Annexes III, IV and V include three modules for conformity 
assessment set out in Anne x II of Decision 768/2008/EC 
– Articles 22-to-38 include the obligations  for the notification of conformity 
assessment bodies set out in chap ter R4 of Decision 768/2008/EC 
– Articles 39-to-43 include the simplified sa feguard procedures set out in chapter 
R5 of Decision 768/2008/EC 
2. Article 2(1) sets out a new definition of  ‘radio equipment’ which demarcates the 
modified scope of the Directive: this  includes all and only equipment which 
intentionally transmits signals using ra dio spectrum, whether for the purpose of 
communication or other. The essential re quirement in Article 3(2) has been 
correspondingly adapted and only refers to transmitted signals. 
In consequence, the propos ed new title for the Dire ctive is: “Directive on the 
harmonisation of the laws of the Member St ates relating to the making available on 
the market of radio equipment” 
3. Article 3(3) (a) makes it possible to requi re radio equipment to interoperate with 
accessories such as chargers 
4. Article 3(3) (g) makes it possible to requ ire software-defined radio equipment to 
ensure that only compliant combinations of  software and hardware come together. 
Article 4 makes it possible to adopt meas ures to avoid that  this regulatory 
requirement creates barriers to competition in the market for third-party software 
5. Article 5 introduces the possibi lity to require the registra tion within a central system 
of products within categories showing low levels of compliance, on the basis of 
information on compliance provided by Member  States in accordance with Article 
47(1) 
6. Article 7 clarifies the relation between  the R&TTE Directive and EU and national 
legislation on the use of radio spectrum 
7. Simplification and reduction of  administrative obligations:   
EN 7   EN – The new definition of radio equipment set out in Article 2(1) establishes a clear 
demarcation of scope with Direc tive 2004/108/EC (the EMC Directive17);  
– Pure receivers and fixed-line terminals cease to fall within the scope of the 
Directive, falling instead within the scope of Directive 2004/108/EC and Directive 2006/95/EC
18, or depending on their voltag e falling within the scope 
of Directive 2004/108/EC and Directive 2001/95/EC19; this entails some 
reduction of administrative obligations; 
– The requirement to notify the placi ng on the market of equipment using 
frequency bands which are not EU-wide harmonised (current Article 6(4)) is 
removed; 
– The obligation to affix an equipment class identifier on th e product (current 
Annex VII(5)) is removed; 
– The requirement to affix CE marking on user instructions (current Annex 
VII(3)) is removed; 
– Requirements supporting competition in the market for terminals (current 
Articles 4(2), 7(3)-to(5)) are removed from  the text of the Directive. Similar 
requirements are in force under Directive 2008/63/EC20. 
8. Alignment with the Treaty on the Functi oning of the European Union and with 
Regulation No 182/2011 on the Commission’s exercise of implementing powers: 
– The procedures for the exercise of imp lementing and delegated powers are laid 
out in Articles 44 (Committee procedure)  and 45 (Exercise of the delegation) 
– Implementing powers are proposed in Artic le 8(3) (determination of equipment 
classes) and Article 10(9) (presentati on of information on geographical area for 
use and on restrictions to use of radio equipment) 
– Delegated powers are proposed in Article 2(3) (adaptation to technical progress 
of Annex II listing some equipment falling or not within the definition of radio 
equipment), Article 3(3) (additional e ssential requirement s), Article 4(2) 
(provision of information on the comp liance of software-defined radio 
equipment), and Article 5(2) (requirement  to register radio equipment within 
some categories) 
                                                 
17 Directive 2004/108/EC of the European Parliame nt and of the Council of 15 December 2004 on the 
approximation of the laws of Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC 
18 Directive 2006/95/EC of the Eu ropean Parliament and of the Council of 12 December 2006 on the 
harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits 
19 Directive 2001/95/EC of the Europ ean Parliament and of the Counc il of 3 December 2001 on general 
product safety  
20 Directive 2008/63/EC of 20 June 2008 on competition in the markets in telecommunications terminal 
equipment  
EN 8   EN 2012/0283 (COD) 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the harmonisation of the laws of the Memb er States relating to the making available 
on the market of radio equipment  
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Economic and Social Committee
21, 
After consulting the European  Data Protection Supervisor22, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Directive 1999/5/EC of the European Pa rliament and of the Council of 9 March 1999 
on radio equipment and telecommunications  terminal equipment and the mutual 
recognition of their conformity
23 has been substantially am ended several times. Since 
further amendments are to be made, it should be replaced in the in terests of clarity.  
(2) Regulation (EC) No 765/2008 of the European  Parliament and of the Council of 9 July 
2008 setting out the requirements for accredi tation and market surveillance relating to 
the marketing of products and repealing Regulation (EEC) No 339/9324 lays down 
rules on the accreditation of conformity assessment bodies, provides a framework for 
the market surveillance of products and for c ontrols on products from third countries, 
and lays down the general principles of the CE marking. 
(3) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 
2008 on a common framework for the marketi ng of products, and repealing Council 
                                                 
21  
22  
23 OJ L 91, 7.4.1999, p. 10. 
24 OJ L 218, 13.8.2008, p. 30.  
EN 9   EN Decision 93/465/EEC25 lays down a common framework of general principles and 
reference provisions intended to apply across the legislation harmonising the 
conditions for the marketing of products in  order to provide a coherent basis for 
revision or recasts of that legislation. Di rective 1999/5/EC should therefore be adapted 
to that Decision.  
(4) The essential requirements in Directive 1999/5/EC which are relevant to fixed-line 
terminal equipment, i.e. the protection of  health and safety and the protection of 
electromagnetic compatibility, are appropria tely covered by Dir ective 2006/95/EC of 
the European Parliament and of the Council of 12 December 2006 on the 
harmonisation of the laws of the Member States relating to electrical equipment 
designed for use within certain voltage limits26 and 2004/108/EC of the European 
Parliament and of the Council of 15 D ecember 2004 on the approximation of the laws 
of Member States relating to electromagnetic compatibility and repealing Directive 
89/336/EEC27. This Directive should therefore not  apply to fixed-line terminal 
equipment. 
(5) Competition issues in the market for term inal equipment are appropriately covered by 
Commission Directive 2008/63/EC of 20 J une 2008 on competition in the markets in 
telecommunications terminal equipment28, in particular thro ugh the obligation for 
national regulatory authorities to ensure the publication of details of technical interface specifications for network access. It is th erefore not necessary to include in this 
Directive requirements facilitating competitio n in the market for terminal equipment 
covered by Directive 2008/63/EC.  
(6) Equipment which intentionally transmits radio waves in order to serve its purpose 
makes systematic use of radio spectrum. In order to ensure an efficient use of spectrum so as to avoid harmfu l interference, all such equi pment should fall within the 
scope of this Directive, whether equipm ent is capable of communication or not. 
(7) Experience has shown the difficulty of es tablishing whether some products fall within 
the scope of Directive 1999/5/EC. In particul ar, in respect of pr oducts resulting from 
technological progress and pres enting difficulties of categoris ation, it is necessary to 
identify categories of products which fall or not within the definition of radio 
equipment. In order to supplement or ame nd certain non-essential elements of this 
Directive, the power to adopt acts in acco rdance with Article 290 of the Treaty on the 
Functioning of the European Union should be  delegated to the Commission in respect 
of amendments of Annex II so as to  adapt it to technical progress. 
(8) The essential requirements in the area of safety laid down by Directive 2006/95/EC 
are sufficient to cover radio equipment, and should therefore be  the reference and 
made applicable by virtue of this Directiv e. In order to avoid unnecessary duplications 
of provisions, other than the essential requirements,  Directive 2006/95/EC should not 
apply to radio equipment. 
                                                
 
25 OJ L 218, 13.8.2008, p. 82. 
26 OJ L 374, 27.12.2006, p. 10. 
27 OJ L 390, 31.12.2004, p. 24. 
28 OJ L 162, 21.6.2008, p. 20.  
EN 10   EN (9) The essential requirements in the area of  electromagnetic compatibility laid down by 
Directive 2004/108/EC are sufficient to cove r radio equipment, and should therefore 
be the reference and made applicable by virt ue of this Directive. In order to avoid 
unnecessary duplications of provisions, other than essential requirements, , Directive 
2004/108/EC should not apply to radio equipment. 
(10) Efficient use of the radio spectrum, accordi ng to the state of the art, should be ensured 
so as to avoid harmful interference.  
(11) Although receivers do not themselves  cause harmful interference, reception 
capabilities are an increasingly important factor in ensuring the efficient use of radio 
spectrum by way of an increased resilien ce of receivers against interference and 
unwanted signals on the basis of the essential requiremen ts of Directive 2004/108/EC. 
(12) Receiver capabilities of receive-only equipment ar e subject to the essential 
requirements of Directive 2004/108/EC in partic ular with regard to unwanted signals 
resulting from the efficient use of shared  or adjacent frequency bands, and it is 
therefore not necessary to include such equi pment within the scope of this Directive. 
(13) In some cases interworking via networks  with other radio equipment and connection 
with interfaces of the a ppropriate type throughout the Union may be necessary. 
Interoperability between radio equipment and accessories such as chargers may simplify use of radio equipment and reduce unnecessary waste. 
(14) The protection of personal data and pr ivacy of users of radio equipment and the 
protection from fraud may be enhanced by pa rticular features of radio equipment. 
Radio equipment should therefore in appropria te cases be designed in such a way that 
it supports those features. 
(15) Radio equipment can be instrumental in  providing access to emergency services. 
Radio equipment should therefore in appropria te cases be designed in such a way that 
it supports those features require d for access to those services. 
(16) Radio equipment is important to the well-being and employment of people with 
disabilities who represent a substantial and growing pr oportion of the population of 
Member States. Radio equipment should theref ore in appropriate cases be designed in 
such a way that disabled people may use it without or with only minimal adaptation.  
(17) The compliance of some categories of ra dio equipment with the essential requirements 
may be affected by the inclusion of software  or modification of its existing software. 
The user, the radio equipment or a third party should only be able to load software into 
the radio equipment where this does not comp romise the subsequent compliance of the 
radio equipment with the appli cable essential requirements. 
(18) It is necessary to provide for a possibility to introduce supplementary requirements 
addressing needs related to interoperability, user priv acy, fraud prevention, use by 
users with a disability, access to emerge ncy services or the prevention of non-
compliant combinations of software and radio equipment. In order to supplement or amend certain non-essential elem ents of this Directive, th e power to a dopt acts in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should be delegated to the Commission in respect of specification of categories or 
classes of radio equipment that need to co mply with additional essential requirements  
EN 11   EN on interoperability, user privacy, fraud pr evention, use by users with a disability, 
access to emergency services or the prev ention of non-compliant combinations of 
software and radio equipment.  
(19) Verification by radio equipment of the co mpliance of its combination with software 
should not be abused in order to prevent it s use with software provided by independent 
parties. The availability to public authori ties, manufacturers and users of information 
on the compliance of intended combinations of radio equipment and software should contribute to facilitate competition. In order to supplement or amend certain non-
essential elements of this Di rective, the power to  adopt acts in accordance with Article 
290 of the Treaty on the Functioni ng of the European Union should be delegated to the 
Commission in respect of specifying categor ies or classes of radio equipment for 
which manufacturers need to provide info rmation on the comp liance of intended 
combinations of radio equipment and soft ware, the information to be communicated 
and the rules on making that information available. 
(20) A requirement to register in a central database radio equipment to be placed on the 
market may enhance the efficiency and effectiveness of market surveillance and therefore contribute to ensure a high leve l of compliance with the Directive. Such a 
requirement entails additional burden to ec onomic operators and should therefore be 
introduced only for those cat egories of radio equipmen t where a high level of 
compliance has not been attained. In or der to supplement or amend certain non-
essential elements of this Di rective, the power to  adopt acts in accordance with Article 
290 of the Treaty on the Functioni ng of the European Union should be delegated to the 
Commission in respect of identifying the rele vant categories of radio equipment to be 
registered in a central database on the basis of information on compliance to be 
provided by Member States, and of specifyi ng the information to be registered, the 
rules applicable for registration and a ffixation of the registration number.  
(21) Radio equipment which complies with the relevant essential requirements should be 
allowed to circulate freely. Such equipment should be allowed to be put into service 
and used for its intended purpose, where ap plicable in accordance with rules on 
authorisations for the use of  radio spectrum and the provision of the service concerned. 
(22) In order to avoid unnecessary barriers to trade in radio equipmen t within the Internal 
Market of the Union, Member States shou ld notify under Directiv e 98/34/EC of the 
European Parliament and of the Council of 22 June 1998 laying down a procedure for 
the provision of information in the fiel d of technical standards and regulations
29 to 
other Member States and to the Commission their projects in th e area of technical 
regulations, such as radio interfaces, but not where these allow Member States to 
comply with binding Union acts such as implementing measures under Decision No 
676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a 
regulatory framework for radio spectr um policy in the European Community30.  
(23) The provision of information on the equiva lence of regulated radio interfaces and their 
conditions of use reduces barriers for the access of radio equipment to the internal 
market. The Commission should therefore as sess and establish th e equivalence of 
                                                 
29 OJ L 204, 21.7.1998, p. 37. 
30 OJ L 108, 24.4.2002, p. 1.  
EN 12   EN those regulated radio interfaces and make av ailable such information in the form of 
radio equipment classes. 
(24) In accordance with Commissi on Decision 2007/344/EC of 16 May 2007 on 
harmonised availability of informati on regarding spectrum use within the 
Community31, Member States have to use the ERO Frequency Information System 
(EFIS) set up by the European Radiocommunications Office (ERO) in order to make comparable information regarding the use of  spectrum in each Member State available 
to the public via the Internet. Manufacturers can search in EFIS frequency information 
for all Union Member States prior to the pl acing on the market of radio equipment and 
so evaluate whether and under which conditions such radio equipment may be used within each Member State. Therefore in this Directive there is no need to include 
additional provisions, such as prior notifica tion, allowing to inform manufacturers of 
the conditions of use of radio equipmen t using non-harmonised frequency bands.  
(25) For the purpose of promotion of research  and demonstration activities it should be 
possible, in the context of trade fairs, exhi bitions and similar events, to exhibit radio 
equipment which does not conform to this  Directive and cannot be placed on the 
market, on the condition that exhibitors ensure sufficient information to the visiting public. 
(26) Economic operators should be responsibl e for the compliance of products, in relation 
to their respective role s in the supply chain, so as to ensure a high level of protection 
of health and safety, of electromagnetic co mpatibility, an efficient use of spectrum so 
as to avoid harmful interference, and to guarantee fair competition on the Union market. 
(27) All economic operators in tervening in the supply and distribution chain should take 
appropriate measures to ensure that they  only make available on the market products 
which are in conformity with this Directive.  It is necessary to provide for a clear and 
proportionate distribution of obligations whic h correspond to the role  of each operator 
in the supply and distribution process. 
(28) The manufacturer, having detailed knowle dge of the design and production process, is 
best placed to carry out the complete c onformity assessment procedure. Conformity 
assessment should therefore remain the ob ligation of the manu facturer alone. 
(29) The manufacturer should provide suffici ent information on the intended use of the 
equipment so as to allow its use in compliance with the essential requirements. Such information may need to include description of accessories such as antennas, components such as software and specifica tions of the installation process of the 
equipment. 
(30) The requirement in Direc tive 1999/5/EC to include an EU  declaration of conformity 
with equipment has been found to simplify and to enhance the information and the efficiency of market surveillance. The possibility to provide a simplified EU 
declaration of conformity has allowed to  reduce the burden associated with this 
requirement without reduction of its effectiveness and should be provided for within 
this Directive. 
                                                
 
31 OJ L 129, 17.5.2007, p. 67.  
EN 13   EN (31) It is necessary to ensure  that products from third count ries entering the Union market 
comply with the requirements of this Direct ive, and in particul ar that appropriate 
assessment procedures have been carried out  by manufacturers with regard to those 
products. Provision should therefore be made  for importers to make sure that the 
products they place on the market comply with  the requirements of this Directive and 
that they do not place on the market products which do not comply with such 
requirements or present a risk. Provision shou ld also be made for importers to make 
sure that conformity assessment procedures  have been carried out and that product 
marking and documentation drawn up by manuf acturers are available for inspection by 
the supervisory authorities. 
(32) The distributor makes radio equipment avai lable on the market after it has been placed 
on the market by the manufacturer or the impo rter and should act with due care to 
ensure that its handling of the radio equipment does not adversely affect the 
compliance of the radio equipment. 
(33) When placing radio equipment on the ma rket, every importer should indicate on the 
radio equipment his name and the address at which he can be contacted. Exceptions 
should be provided for in cases where the si ze or nature of the equipment does not 
allow it. This includes cases where the im porter would have to open the packaging to 
put his name and address on the radio equipment. 
(34) Any economic operator that either place s radio equipment on the market under his 
own name or trademark or modifies radio equipment in such a way that compliance 
with the requirements of this Directive may be affected should be considered to be the 
manufacturer and should assume the obligations of the manufacturer. 
(35) Distributors and importers, being close to the market place, should be involved in 
market surveillance tasks carried out by the competent national authorities, and should 
be prepared to participate actively, providing t hose authorities with all necessary 
information relating to the radio equipment concerned. 
(36) Ensuring traceability of radio equipmen t throughout the whole supply chain helps to 
make market surveillance simpler and more e fficient. An efficient traceability system 
facilitates market surveillan ce authorities' task of tracing economic operators who 
made non-compliant radio equipment available on the market. 
(37) This Directive should be limited to the expression of essential requirements. In order 
to facilitate conformity assessment with t hose requirements it is necessary to provide 
for presumption of conformity for radio equipment which is in conformity with 
harmonised standards that are adopted in accordance with Regulation (EU) No [../..] 
[on European Standardisation ]32 for the purpose of expressing detailed technical 
specifications of those requirements.  
(38) Regulation (EU) No [../..] [ on European Standardisation ] provides for a procedure for 
objections to harmonised standards where those standards do not  entirely satisfy 
requirements of this Directive.  
                                                 
32 OJ L […], […], p. […].  
EN 14   EN (39) In order to enable economic operators to  demonstrate and the competent authorities to 
ensure that radio equipment made available on the market conforms to the essential 
requirements it is necessary to provide for conformity assessment procedures. 
Decision No 768/2008/EC establishes modules for conformity assessment procedures, 
which include procedures from the least to the most stringent, in proportion to the level of risk involved and the le vel of safety required. In or der to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, c onformity assessment procedures should be 
chosen from among those modules. 
(40) Manufacturers should draw up an EU declar ation of conformity to provide detailed 
information on the conformity of radio e quipment with the requirements of this 
Directive and of the other releva nt Union harmonisation legislation. 
(41) The CE marking, indicating the conformity of a product, is the vi sible consequence of 
a whole process comprising conformity assessment in a broad sense. General 
principles governing the CE marking ar e set out in Regulation (EC) No 765/2008. 
Rules governing the affixing of the CE marki ng should be laid down in this Directive. 
(42) The requirement to affix the CE marking on products is important for the information 
of consumers and public author ities. The possibility in Di rective 1999/5/EC to affix a 
reduced CE mark on small equipment, provided that it remains visible and legible, has 
allowed to simplify application of this re quirement without reducing its effectiveness 
and should therefore be incl uded in this Directive. 
(43) The requirement in Dir ective 1999/5/EC to affix the CE  marking on the packaging of 
equipment has been found to simplify the task of market su rveillance and should 
therefore be included in this Directive. 
(44) The conformity assessment procedures set out in this Directive require the intervention 
of conformity assessment bodies, which are notified by the Member States to the Commission. 
(45) Experience has shown that the criter ia set out in Direc tive 1999/5/EC that the 
conformity assessment bodies have to fulfil to be notified to the Commission are not 
sufficient to ensure a uniformly high le vel of performance of notified bodies 
throughout the Union. It is, however, essentia l that all notified bodies perform their 
functions to the same level and under conditi ons of fair competition. That requires the 
setting of obligatory requirements for conf ormity assessment bodies wishing to be 
notified in order to provide conformity assessment services. 
(46) In order to ensure a consistent level of conformity assessment quality it is also 
necessary to set requirements  for notifying authorities and other bodies involved in the 
assessment, notification and monitoring of notified bodies. 
(47) If a conformity assessment body demonstrat es conformity with the criteria laid down 
in harmonised standards, it should be presumed to co mply with the corresponding 
requirements set out in this Directive. 
(48) The system set out in this Directiv e should be complemented by the accreditation 
system provided for in Regulation (EC)  No 765/2008. Since ac creditation is an 
essential means of verifying the compet ence of conformity assessment bodies, it 
should also be used for th e purposes of notification.  
EN 15   EN (49) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confidence in confor mity certificates, should be considered by 
the national public authorities throughout the Union as the preferred means of 
demonstrating the technical competence of conformity assessment bodies. However, 
national authorities may consider that they  possess the appropriate means of carrying 
out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national author ities, they should 
provide the Commission and th e other Member States with the necessary documentary 
evidence demonstrating the compliance of th e conformity assessment bodies evaluated 
with the relevant regu latory requirements. 
(50) Conformity assessment bodies frequently su bcontract parts of thei r activities linked to 
the assessment of conformity or have recour se to a subsidiary. In  order to safeguard 
the level of protection require d for radio equipment to be placed on the Union market, 
it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in re lation to the performance of conformity 
assessment tasks. Therefore, it is important  that the assessment of the competence and 
the performance of bodies to be notified and the monitori ng of bodies al ready notified 
cover also activities carried out by subcontractors and subsidiaries. 
(51) It is necessary to increase the efficiency  and transparency of the notification procedure 
and, in particular, to adapt it to new technol ogies so as to enable online notification. 
(52) Since notified bodies may offer their serv ices throughout the Union, it is appropriate to 
give the other Member States and the Co mmission the opportunity to raise objections 
concerning a notified body. It is therefore important to provide for a period during 
which any doubts or concerns as to the co mpetence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 
(53) In the interests of competitiveness, it is crucial that no tified bodies apply the 
conformity assessment procedures without  creating unnecessary burdens for economic 
operators. For the same reason, and to ensu re equal treatment of  economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to be ensured. That can best be achie ved through appropriate  coordination and 
cooperation between notified bodies. 
(54) In order to ensure legal certainty, it is necessary to clar ify that rules on Union market 
surveillance and control of products ente ring the Union market provided for in 
Regulation (EC) No 765/2008 apply to radio equipment. 
(55) Directive 1999/5/EC alrea dy provides for a safeguard proc edure which applies only in 
the event of disagreement between Member States over measures taken by a Member State. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard clause pr ocedure, with a view to making it more 
efficient and drawing on the expert ise available in Member States. 
(56) The existing system should be supple mented by a procedure under which interested 
parties are informed of measures intended to  be taken with regard  to radio equipment 
presenting a risk to the health and safety of persons or to other aspects of public 
interest covered by the essential requirements  in this Directive. It should also allow  
EN 16   EN market surveillance authorit ies, in cooperation with the relevant economic operators, 
to act at an earlier stage in  respect of such equipment. 
(57) Where the Member States and the Comm ission agree as to the justification of a 
measure taken by a Member State, no furt her involvement of the Commission should 
be required, except where non-compliance ca n be attributed to shortcomings of a 
harmonised standard. 
(58) In order to ensure uniform conditions  for the implementati on of this Directive , 
implementing powers should be conferred on the Commission. Those powers should 
be exercised in accordance with Regulation (EU) 182/2011 of the European Parliament and of the Council of 16 Februa ry 2011 laying down the rules and general 
principles concerning mechanisms for cont rol byMember States of the Commission's 
exercise of implementing powers
33.  
(59) It is of particular importance that th e Commission carry out a ppropriate consultations 
during its preparatory work of delegated acts, includi ng at expert level. The 
Commission, when preparing and drawing- up delegated acts, should ensure a 
simultaneous, timely and appropriate transm ission of relevant documents to the 
European Parliament and the Council. 
(60) The Member States should lay down rules on penalties applicable to infringements of 
the national provisions adopted pursuant to th is Directive and ensure that they are 
implemented. Those penalties should be effective, proportionate and dissuasive. 
(61) It is necessary to provide for transitional arrangem ents that allow making available on 
the market and putting into service radio eq uipment that have already been placed on 
the market in accordance with Directive 1999/5/EC. 
(62) Since the objective of this Directive, namely to ensure that radio equipment on the 
market fulfils requirements providing a high le vel of protection of health and safety, of 
electromagnetic compatibility and an efficien t use of spectrum so as to avoid harmful 
interference while guaranteeing the functi oning of the internal market, cannot be 
sufficiently achieved by the Member States and can therefore, by reason of its scale 
and effects, be better achieved at Union level, the Union may adopt measures, in 
accordance with the principle of  subsidiarity as set out in  Article 5 of the Treaty on 
European Union. In accordance with the princi ple of proportionality, as set out in that 
Article, this Directive does not go beyond what is necessary in order to achieve that 
objective.  
(63) In accordance with the Joint Political Declaration of Member States and the 
Commission on explanatory documents of 28 September 2011, Member States have 
undertaken to accompany, in justified cases,  the notification of their transposition 
measures with one or more documents explaining the relationship between the 
components of a directive and the corres ponding parts of nati onal transposition 
instruments. With regard to this Directive,  the legislator consid ers the transmission of 
such documents to be justified. 
                                                 
33 OJ L 55 of 28.2.2011, p. 13.  
EN 17   EN HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER  I 
GENERAL  PROVISIONS 
Article 1 
Subject matter and scope 
1. This Directive establishes a regulatory framework for the making available on the 
market and putting into service in  the Union of radio equipment. 
2. This Directive shall not apply to equipment listed in Annex I. 3. This Directive shall not apply to radio equipment exclusively used for activities 
concerning public security, defence, Stat e security, including the economic well-
being of the State in the case of activities pertaining to Stat e security matters, and the 
activities of the State in the area of criminal law. 
4. Radio equipment falling within the scope of  this Directive shall not be subject to 
Directive 2006/95/EC, except as set out in  Article 3(1)(a) of this Directive. 
Article 2 
Definitions 
1. For the purpose of this Directive the following definitions shall apply: 
(1) ‘radio equipment’ means a product which inte ntionally emits radio waves in order to 
serve its purpose, or a product which must be completed with an accessory, such as 
antenna, so as to emit radio waves in order to serve its purpose; 
(2) ‘radio waves’ means electromagnetic waves of frequencies from 9 kHz to 3000 GHz, 
propagated in space without artificial guide; 
(3) ‘interface’ means an air in terface specifying the radio path between radio equipment 
and their technical specifications; 
(4) ‘radio equipment class’ means a class iden tifying particular categories of radio 
equipment which under this Directive are c onsidered similar and those interfaces for 
which the equipment is designed; 
(5) ‘harmful interference’ means harmful in terference as defined in Directive 
2002/21/EC of the European Parliament and of the Council
34; 
                                                 
34 OJ L 108, 24.4.2002, p. 33.  
EN 18   EN (6) ‘making available on the market’ means any supply of radio equipment for 
distribution, consumption or use in the Eu ropean Union market in the course of a 
commercial activity, whether in return  for payment or free of charge; 
(7) ‘placing on the market’ means the first making available of radio equipment on the 
European Union market; 
(8) ‘manufacturer’ means any natural or legal person who manufactures radio equipment 
or has radio equipment desi gned or manufactured, and ma rkets that equipment under 
his name or trademark; 
(9) ‘authorised representative’ m eans any natural or legal person established within the 
European Union who has received a written mandate from a manufacturer to act on 
his behalf in relation to specified tasks; 
(10) ‘importer’ means any natural or legal person established within the European Union 
who places radio equipment from a third country on the European Union market; 
(11) ‘distributor’ means any natural or legal pe rson in the supply chain, other than the 
manufacturer or the importer, who makes radio equipment available on the market; 
(12) ‘economic operators’ means the manufactur er, the authorised representative, the 
importer and the distributor; 
(13) ‘technical specification’ means a document that prescribes technical requirements to 
be fulfilled by radio equipment; 
(14) ‘harmonised standard’ means harmonised stan dard as defined in Article 2(1)(c) of 
Regulation (EU) No [../..] [ on European Standardisation ]35; 
(15) ‘accreditation’ means accreditation as defined in Regulati on (EC) No 765/2008; 
(16) ‘national accreditation body’ means na tional accreditation body as defined in 
Regulation (EC) No 765/2008; 
(17) ‘conformity assessment’ means the process demonstrating whether the essential 
requirements relating to radio equipment have been fulfilled; 
(18) ‘conformity assessment body’ means a body that performs conformity assessment 
activities; 
(19) ‘recall’ means any measure aimed at achieving the return of radio equipment that has 
already been made available to the user; 
(20) ‘withdrawal’ means any measur e aimed at preventing radio equipment in the supply 
chain from being made available on the market; 
(21) ‘CE marking’ means a marking by which the manufacturer indicates that radio 
equipment is in conformity with the applicable requirements set out in European Union harmonisation legislation providing for its affixing; 
                                                
 
35 OJ L […], […], p. […].  
EN 19   EN (22) ‘ Union harmonisation legislation’ mean s any Union legislation harmonising the 
conditions for the marketing of products. 
2. For the purposes of point 1 of paragraph 1 of this Article, produc ts listed under point 
1 of Annex II shall be deemed to be radi o equipment, and products listed under point 
2 of Annex II shall not be deemed to be radio equipment.  
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 45 modifying Annex II in order to adapt it to technical progress. 
Article 3 
Essential requirements 
1. Radio equipment shall be constructed so as to ensure: 
(a) the protection of the health and the safe ty of the user and any other person, 
including the objectives with respect to safety requirements set out in Directive 
2006/95/EC, but with no vo ltage limit applying; 
(b) the protection of electromagnetic comp atibility as set out in Directive 
2004/108/EC, including in particular le vels of immunity which lead to 
improvements in the efficient use of shared or adjacent frequency bands.  
2. Radio equipment shall be so constructed that its transmitted signals efficiently use 
the spectrum allocated to terrestrial/space radio communication and orbital resources 
so as to avoid harmful interference. Only ra dio equipment that can be operated in at 
least one Member State without infringing  applicable requirements on the use of 
spectrum can comply with this requirement. 
3. Radio equipment shall be so constructed that it complies with the following essential 
requirements:  
(a) radio equipment interworks with accessori es, and/or it interw orks via networks 
with other radio equipment, and/or it can be connected to interfaces of the 
appropriate type throughout the Union; 
(b) radio equipment does not harm the ne twork or its functioning nor misuse 
network resources, thereby causing an unacceptable degradation of service; 
(c) radio equipment incorporates safeguards to ensure that the personal data and 
privacy of the user and of the subscriber are protected; 
(d) radio equipment supports certain feat ures ensuring avoidance of fraud; 
(e) radio equipment supports certain feat ures ensuring access to emergency 
services; 
(f) radio equipment supports certain features in  order to facilitate its use by users 
with a disability;  
EN 20   EN (g) radio equipment supports certain features in order to ensure that software can 
only be loaded into the radio equi pment where the compliance of the 
combination of software and the radio equipment has been demonstrated. 
The Commission shall be empowered to adopt delegated acts in accordance with Article 45 
specifying which categories or classes of ra dio equipment are concerned by each of the 
requirements (a) to (g) in  the first subparagraph.  
Article 4 
Provision of information on the complian ce of combinations of software and radio 
equipment 
1. Manufacturers of radio equipment and of so ftware allowing radio equipment to be 
used as intended shall provide the Me mber States and the Commission with 
information on the compliance of intended combinations of radio equipment and software with the essential requirements set out in Article 3. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 45 specifying which categories or cl asses of radio equipment are concerned 
by the requirement in the paragraph 1, th e required information and the operational 
rules for making the information on compliance available. 
Article 5 
Registration of radio equipm ent within some categories  
1. As from [date - four years after the date of entry into force of the Directive ], 
manufacturers shall register  radio equipment types with in categories of equipment 
affected by a low level of compliance with the essential requirements set out in Article 3 within a central system referred to  in paragraph 3 prior to radio equipment 
within those categories being placed on th e market. The Commission shall allocate to 
each registered type a registration number , which manufacturers shall affix on radio 
equipment placed on the market. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 45 specifying which categories of radio equi pment are concerned by the 
requirement set out in the paragraph 1, taking into account information on the 
compliance of equipment provided by Memb er States in accordance with Article 
47(1), the information to be registered, th e operational rules for registration and the 
operational rules for affixation of the re gistration number on radio equipment.  
3. The Commission shall make available a cen tral system allowing manufacturers to 
register the required information.  
Article 6 
Placing on the market   
EN 21   EN Member States shall ensure that radio equipmen t is made available on the market only if it 
complies with this Directive when it is properl y installed and maintained and used for its 
intended purpose. 
Article 7 
Putting into service and use 
Member States shall allow the putting into service and use of radio equipment for its intended 
purpose where it complies with this Directive.  Without prejudice to their obliga tions under 
Decision No 676/2002/EC, and to the conditions a ttached to authorisations for the use of 
frequencies in conformity with Union law, in  particular under Articles 9(3) and 9(4) of 
Directive 2002/21/EC, Member States may onl y introduce additional requirements for the 
putting into service and/or use of  radio equipment for reasons related to the efficient use of 
the radio spectrum, avoidance of harmful inte rference or matters rela ting to public health. 
Article 8 
Notification of interface specifica tions and radio equipment classes 
1. Member States shall notify in accordance with the procedure se t out in Directive 
98/34/EC the interfaces which they intend to regulate.  
2. When assessing correspondence between ra dio equipment and re gulated interfaces, 
Member States shall take into account the equivalence with radi o interfaces notified 
by other Member States.  
3. The Commission shall establish the equivalence between notified interfaces and 
assign a radio equipment class, details of which shall be published in the Official 
Journal of the European Union. Those im plementing acts shall be adopted in 
accordance with the advisory procedur e referred to in Article 44(2). 
Article 9 
Free movement of radio equipment  
1. Member States shall not pr ohibit, restrict or impede, for reasons relating to those 
aspects covered by this Directive, the placing on the market in their territory of radio 
equipment complying with this Directive.  
2. At trade fairs, exhibitions, demonstrations  and similar events, Member States shall 
not create any obstacles to the display of  radio equipment which does not comply 
with this Directive, provided that a visi ble sign clearly indicates that such radio 
equipment may not be marketed or used  until it has been made to comply.  
EN 22   EN CHAPTER  II 
OBLIGATIONS  OF ECONOMIC  OPERATORS   
Article 10 
Obligations of manufacturers 
1. When placing radio equipment on the market , manufacturers shall ensure that it has 
been designed and manufactured in accordan ce with the essential requirements set 
out in Article 3. 
2. Manufacturers shall draw up the technical documentation referred to in Article 21 
and carry out the conformity assessment proce dure referred to in Article 17 or have it 
carried out. 
Where compliance of radio equipment with  the applicable requirements has been 
demonstrated by that procedure, manufacturer s shall draw up an EU declaration of 
conformity and affix the CE marking. 
3. Manufacturers shall keep the technical documentation and the EU declaration of 
conformity for 10 years after radio equipment has been placed on the market. 
4. Manufacturers shall ensure that procedur es are in place for series production to 
remain in conformity. Changes in radio equipment design or characteristics and 
changes in the harmonised sta ndards or in technical spec ifications by reference to 
which conformity of apparatus is declared shall be adequately taken into account.  
When deemed appropriate with regard to  the risks presented by radio equipment, 
manufacturers shall carry out sample testi ng of radio equipment made available on 
the market, investigate, and, if necessar y, keep a register of  complaints, of non-
conforming radio equipment and radio equipm ent recalls, and shall keep distributors 
informed of any such monitoring. 
5. Manufacturers shall ensure th at radio equipment bears a ty pe, batch or serial number 
or other element allowing their identificati on, or, where the size or  nature of radio 
equipment does not allow it, that the required information is provided on the packaging, or in a document accompanying radio equipment. 
6. Manufacturers shall indicate their name, regi stered trade name or registered trade 
mark and the address at which they can be contacted on radio equipment or, where the size or nature of radio equipment does not allow it, on its packaging, or in a 
document accompanying radio equipment. The address must indicate a single point at which the manufactur er can be contacted. 
7. Manufacturers shall ensure that radio equipment is accompanied by instructions and 
safety information in a language which can be easily understood by consumers and 
other users, as determined by the Member State concerned. Instru ctions shall include 
the information required to use radio equipment in accordance with its intended use.  
EN 23   EN Such information shall include, where applicable, a description of accessories and/or 
components, including software, which a llow the radio equipment to operate as 
intended.  
The following information shall also be included: frequency band(s) in which th e radio equipment operates; 
radio-frequency power transmitted in the frequency band(s) in which the radio 
equipment operates. 
8. A copy of the full EU declaration of conf ormity shall accompany each piece of radio 
equipment. This requirement may also be  fulfilled by the provision of a simplified 
EU declaration of conformity. Where only a simplified EU declara tion of conformity 
is provided, it shall be immediately followed by the exact internet or e-mail address 
where the full EU declaration of conformity can be obtained.  
9. Information available on the packaging shall allow to identify the Member States or 
the geographical area within a Member State where radio equipment can be put into service, and shall alert the user to pot ential restrictions or requirements for 
authorisation of use in certain Member St ates. Such information shall be completed 
in the instructions accompanying radio equipment. The Commission may adopt 
implementing acts specifying how to presen t this information. Those implementing 
acts shall be adopted in accord ance with the advisory procedure referred to in Article 
44(2). 
10. Manufacturers who consider or have reas on to believe that radio equipment which 
they have placed on the market is not in  conformity with this Directive shall 
immediately take the necessary corrective measures to bring that radio equipment 
into conformity, to withdraw it or recall it, if appropria te. Furthermore, where radio 
equipment presents a risk, manufacturers shall immediately inform the competent 
national authorities of  the Member States in whic h they made radio equipment 
available to that effect, giving details, in particular, of the non-compliance and of any 
corrective measures taken. 
11. Manufacturers shall, further to a reas oned request from a competent national 
authority, provide it without delay with  all the information and documentation 
necessary to demonstrate the conformity of radio equipment, in a language which can 
be easily understood by that authority. They sh all cooperate with that authority, at its 
request, on any action taken to  eliminate the risks posed by radio equipment which 
they have placed on the market. 
Article 11  
Authorised representatives 
1. A manufacturer may, by a written mandate, a ppoint an authorised representative.  
The obligations laid down in Article 10(1) and the drawi ng up of technical 
documentation shall not form part of th e authorised representative's mandate.  
EN 24   EN 2. An authorised representative shall pe rform the tasks specified in the mandate 
received from the manufacturer. The ma ndate shall allow the authorised 
representative to do at  least the following: 
(a) keep the EU declaration of conformity  and the technical documentation at the 
disposal of national surveillance aut horities for 10 years after the radio 
equipment has been placed on the market; 
(b) further to a reasoned request from a co mpetent national authority, provide that 
authority with all the information and documentation necessary to demonstrate the conformity of radio equipment; 
(c) cooperate with the competent national authorities, at their request, on any 
action taken to eliminate the risks pos ed by radio equipment covered by the 
authorised representative’s mandate. 
Article 12 
Obligations of importers 
1. Importers shall place only compliant radio equipment on the market. 
2. Before placing radio equipment on the ma rket importers shall ensure that the 
appropriate conformity assessment pr ocedure has been carried out by the 
manufacturer. They shall ensure that th e manufacturer has drawn up the technical 
documentation, that the radio equipment b ears the CE marking and is accompanied 
by the information for users and regulatory authorities referred to in Article 10(7), 
(8) and (9), and that the manufacturer ha s complied with the requirements set out in 
Article 10(5) and (6). 
Where an importer considers or has reason to  believe that radio equipment is not in 
conformity with the essential requirements set out in Article 3, he shall not place the radio equipment on the market until it has been brought into conformity. 
Furthermore, where radio equipment presen ts a risk, the importer shall inform the 
manufacturer and the market survei llance authorities to that effect. 
3. Importers shall indicate their name, regist ered trade name or registered trade mark 
and the address at which they can be contac ted on the radio equipment or, where that 
is not possible, on its packaging or in a document accompanying the radio equipment. This includes cases where the si ze of radio equipment does not allow it, 
or where importers would have to open the p ackaging in order to indicate their name 
and address on radio equipment. 
4. Importers shall ensure that the radio equipment is accompanied by instructions and 
safety information in a language which can be easily understood by consumers and 
other users, as determined by the Member State concerned. 
5. Importers shall ensure that, while radio equipment is under their responsibility, 
storage or transport conditions do not jeopa rdise its compliance with the essential 
requirements set out in Article 3.  
EN 25   EN 6. When deemed appropriate with regard to  the risks presented by radio equipment, 
importers shall, to protect the health and safety of consumers, carry out sample testing of radio equipment made availa ble on the market, investigate, and, if 
necessary, keep a register of complaints , of non-conforming radio equipment and 
radio equipment recalls, and shall keep di stributors informed of such monitoring. 
7. Importers who consider or have reason to  believe that radio equipment which they 
have placed on the market is  not in conformity  with this Directive shall immediately 
take the corrective measures necessary to bring that radi o equipment into  conformity, 
to withdraw it or recall it, if appropriat e. Furthermore, where the radio equipment 
presents a risk, importers shall immediatel y inform the competent national authorities 
of the Member States in which they made  the radio equipment available to that 
effect, giving details, in particular, of the non-compliance and of any corrective 
measures taken. 
8. Importers shall, for a period of ten year s after the radio equipment has been placed 
on the market, keep a copy of the EU declarat ion of conformity at the disposal of the 
market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. 
9. Importers shall, further to a reasoned re quest from a competent national authority, 
provide it without delay with all the in formation and documentation necessary to 
demonstrate the conformity of radio equipment in a language which can be easily understood by that authority. They  shall cooperate w ith that authority, at its request, 
on any action taken to eliminate the risks posed by the radio equipment which they 
have placed on the market. 
Article 13 
Obligations of distributors 
1. When making radio equipment available on the market distributors shall act with due 
care in relation to the requirements of this Directive. 
2. Before making radio equipment available on the market distributors shall verify that 
the radio equipment bears the required CE marking, that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and ot her users in the Member State in which 
the radio equipment is to be made availabl e on the market, and that the manufacturer 
and the importer have complied with the requi rements set out in Article 10(5) to (9), 
and Article 12(3). 
Where a distributor considers or has reason to  believe that radio equipment is not in 
conformity with the essential requirements se t out in Article 3, he shall not make the 
radio equipment available on the market until it has been brought into conformity. Furthermore, where radio equipment presents  a risk, the distributor shall inform the 
manufacturer or the importer to that e ffect as well as the market surveillance 
authorities.  
EN 26   EN 3. Distributors shall ensure that, while radi o equipment is under their responsibility, 
storage or transport conditions do not jeopa rdise its compliance with the essential 
requirements set out in Article 3.  
4. Distributors who consider or have reason to believe that radio equipment which they 
have made available on the market is not in conformity with this Directive shall 
make sure that the corrective measures neces sary to bring that radio equipment into 
conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where 
radio equipment presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the radio equipment 
available to that effect, giving details, in particular, of the non-compliance and of any 
corrective measures taken. 
5. Distributors shall, further to a reasoned  request from a competen t national authority, 
provide it without delay with all the in formation and documentation necessary to 
demonstrate the conformity of radio equi pment. They shall cooperate with that 
authority, at its request, on any action take n to eliminate the risks posed by radio 
equipment which they have made available on the market. 
Article 14 
Cases in which obligations of manufactu rers apply to importers and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Directive and he shall be subj ect to the obligations  of the manufacturer under Article 10, 
where he places radio equipment on the market  under his name or trademark or modifies 
radio equipment already placed on the market  in such a way that compliance with the 
requirements of this Directive may be affected. 
Article 15 
Identification of economic operators 
Economic operators shall, on request, identify the following to the market surveillance 
authorities: 
(a) any economic operator who has supp lied them with radio equipment; 
(b) any economic operator to whom they have supplied radio equipment. 
Economic operators shall be able to present the information refe rred to in the first paragraph 
for a period of 10 years after they have been  supplied with the radio equipment and for a 
period of 10 years after they have  supplied the radio equipment.  
EN 27   EN CHAPTER  III 
CONFORMITY  OF RADIO  EQUIPMENT 
Article 16 
Presumption of conformity and harmonised standards 
1. Radio equipment which is in conformity with harmonised standards or parts thereof 
the references of which have been publishe d in the Official Jour nal of the European 
Union shall be presumed to be in conform ity with the essential requirements covered 
by those standards or parts ther eof, set out in Article 3  
2. Where a harmonised standard satisfies th e requirements which it covers and which 
are set out in Article 3 or Article 27, the Commission shall publish the references of 
those standards in the Official Journal of the European Union.  
Article 17 
Conformity assessment procedures 
1. Manufacturers may demonstrate compliance of radio equipment with the essential 
requirements identified in Articles 3( 1)(a) and (b) using any of the following 
conformity assessment procedures: 
(a)  internal production control procedure set out in Annex III; 
(b)  EU-type examination followed by the conf ormity to type procedure set out in 
Annex IV; 
(c)  full quality assurance pro cedure set out in Annex V. 
2. Where in assessing the compliance of  radio equipment with the essential 
requirements identified in Articles 3(2)  and (3), the manufacturer has applied 
harmonised standards, the reference number of which has been published in the Official Journal of the European Union, he  may use any of the following procedures: 
(a) internal production control procedure set out in Annex III; 
(b) EU-type examination followed by the confor mity to type procedure set out in 
Annex IV; 
(c) full quality assurance proce dure set out in Annex V. 
3. Where in assessing the compliance of  radio equipment with the essential 
requirements identified in Articles 3(2) a nd (3), the manufacturer has not applied or 
has applied only in part harmonised standa rds the reference number of which has 
been published in the Official Journal of the European Union, or where such 
harmonised standards do not exist, radio equipment shall be submitted with regard to  
EN 28   EN those essential requirements to the pro cedure set out in either of the following 
procedures: 
(a) EU-type examination followed by the confor mity to type procedure set out in 
Annex IV; 
(b) full quality assurance proce dure set out in Annex V. 
Article 18 
EU declaration of conformity 
1. The EU declaration of conformity shall state that the fulfilment of the essential 
requirements set out in Article  3 has been demonstrated. 
2. The EU declaration of conformity shall have the model struct ure and shall contain 
the elements set out in A nnex VII and shall be conti nuously updated. It shall be 
translated into the language or languages required by the Member State in which market the radio equipment is placed or made available. 
The simplified EU declaration of conformity referred to in  Article 10(8) shall contain 
the elements set out in Annex VIII and sh all be continuously updated. It shall be 
translated into the language or languages required by the Member State in which market the radio equipment is placed or made available. The full EU declaration of conformity accessible through internet or e-mail address shall be available in a 
language or languages required by the Member State in which market the radio equipment is placed or made available. 
3. Where the radio equipment is subject to more than one Union act requiring an EU 
declaration of conformity, a si ngle EU declaration of confor mity shall be drawn up in 
respect of all such Union acts. That declar ation shall contain the identification of the 
acts concerned including the publication references. 
4. By drawing up the EU declaration of c onformity, the manufacturer shall assume 
responsibility for the compliance of radio equipment. 
Article 19 
General principles of the CE marking 
1. The CE marking shall be subject to the ge neral principles set out in Article 30 of 
Regulation (EC) No 765/2008.  
2. On account of the nature of radio equipment,  the height of the CE marking affixed to 
radio equipment may be lower than 5 mm , provided that it remains visible and 
legible. 
Article 20 
Rules and conditions for affixing the CE marking  
EN 29   EN 1. The CE marking shall be affixed visibly, le gibly and indelibly to the radio equipment 
or to its data plate, unless that is not possible or not warranted on account of the 
nature of radio equipment. The CE marking shall also be affixe d visibly and legibly 
to the packaging. 
2. The CE marking shall be affixed before radio equipment is placed on the market.  
3. The CE marking shall be followed by the identification number of the notified body 
where the conformity assessment proce dure set out in Annex V is applied. 
The identification number of the notified body shall have the same height as the CE marking.  It shall be affixed by the body itself or, under its instructions , by the manufacturer or his 
authorised representative. 
Article 21 
Technical documentation  
1. The technical documentation shall contain a ll relevant data or details of the means 
used by the manufacturer to ensure th at radio equipment complies with the 
requirements set out in Article 3. It shall, at least, contain the documents listed in Annex VI.  
2. The technical documentation shall be draw n up before radio equipment is placed on 
the market and shall be continuously updated. 
3. The technical documentation and corre spondence relating to any EU-type 
examination procedures shall be drawn up in an official language of the Member State in which the notified body is established or in a la nguage acceptable to that 
body.  
4. Technical documentation drawn up in accordance with the corresponding 
specifications of the national standard th at implements the relevant harmonised 
standard and/or technical sp ecification shall be presumed  to provide an adequate 
basis for the assessment of conformity. 
5. Following a reasoned request from the mark et surveillance authority of a Member 
State, the manufacturer shall provide a tr anslation of the relevant parts of the 
technical documentation into the la nguage of that Member State.  
When a market surveillance authority re quests the technical documentation from a 
manufacturer, it shall be transmitted wit hout delay. When a market surveillance 
authority requests from a manufacturer a tr anslation of technical documentation or 
parts thereof, it may fix a deadline for recei pt of such translation, which shall be 30 
days, unless a shorter deadline is justified in  the case of serious and immediate risk.  
6. Where the technical documenta tion does not comply with para graphs 1, 2 or 3 of this 
Article, and in so doing fails to present su fficient relevant data or means used to 
ensure compliance of radio equipment with the requirements set out in Article 3, the market surveillance authority may require th e manufacturer to have a test performed  
EN 30   EN by a body acceptable to the market surveilla nce authority at the expense of the 
manufacturer within a specified period in  order to verify compliance with the 
essential requirements set out in Article 3.  
CHAPTER  IV 
NOTIFICATION  OF CONFORMITY  ASSESSMENT  BODIES 
Article 22 
Notification 
Member States shall notify the Commission and th e other Member States of bodies authorised 
to carry out third-party conformity as sessment tasks under this Directive.  
Article 23 
Notifying authorities 
1. Member States shall designate a notifying authority that shall be responsible for 
setting up and carrying out the necessary procedures  for the assessment and 
notification of conformity assessment bodi es and the monitoring of notified bodies, 
including compliance with Article 28. 
2. Member States may decide that the a ssessment and monitoring referred to in 
paragraph 1 shall be carried out by a natio nal accreditation body within the meaning 
of and in accordance with Regulation (EC) No 765/2008. 
3. Where the notifying authority delegates or otherwise entrusts the assessment, 
notification or monitoring referred to in  paragraph 1 to a body which is not a 
governmental entity, that body shall be a legal entity and shall comply mutatis 
mutandis with the requirements laid down in Ar ticle 24(1) to (6). In addition it shall 
have arrangements to cover liabilit ies arising out of its activities. 
4. The notifying authority shall take full re sponsibility for the tasks performed by the 
body referred to in paragraph 3. 
Article 24 
Requirements relating to notifying authorities 
1. A notifying authority shall be established in  such a way that no conflict of interest 
with conformity assessment bodies occurs. 
2. A notifying authority shall be organise d and operated so as to safeguard the 
objectivity and impartiality of its activities.  
EN 31   EN 3. A notifying authority shall be organised in such a way that  each decision relating to 
notification of a conformity  assessment body is taken by competent persons different 
from those who carried out the assessment. 
4. A notifying authority shall not offer or  provide any activities that conformity 
assessment bodies perform or consultancy services on a commercial or competitive basis. 
5. A notifying authority shall safeguard the c onfidentiality of the information it obtains. 
6. A notifying authority shall have a suffici ent number of competent personnel at its 
disposal for the proper performance of its tasks. 
Article 25 
Information obligation on  notifying authorities 
Member States shall inform the Commission of their proce dures for the assessment and 
notification of conformity assessment bodies and the monitoring of notified bodies, and of 
any changes thereto. 
The Commission shall make that information publicly available. 
Article 26 
Requirements relating to notified bodies 
1. For the purposes of notification, a c onformity assessment body shall meet the 
requirements laid down in paragraphs 2 to 11. 
2. A conformity assessment body shall be established under national law and have legal 
personality. 
3. A conformity assessment body shall be a third-party body i ndependent of the 
organisation or the radio equipment it assesses. 
A body belonging to a business association or professional federation representing 
undertakings involved in the design, manufacturing, pr ovision, assembly, use or 
maintenance of radio equipment which it  assesses, may, on condition that its 
independence and the absence of any conf lict of interest are demonstrated, be 
considered such a body. 
4. A conformity assessment body, its top level management and the personnel 
responsible for carrying out  the conformity assessmen t tasks shall not be the 
designer, manufacturer, supplier, installer, pu rchaser, owner, user or maintainer of 
the radio equipment which they assess, nor the authorised repres entative of any of 
those parties. This shall not preclude the use of assessed radio equipment that is necessary for the operations of the confor mity assessment body or the use of such 
radio equipment for personal purposes.  
EN 32   EN A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conformity  assessment tasks shall not be directly 
involved in the design, manuf acture or construction, the marketing, installation, use 
or maintenance of that radio equipment, or represent the part ies engaged in those 
activities. They shall not engage in a ny activity that may conflict with their 
independence of judgement or integrity in relation to conformity assessment 
activities for which they are notified. This shall in particular apply to consultancy 
services. 
Conformity assessment bodies shall ensure that  the activities of th eir subsidiaries or 
subcontractors do not affect the confidentia lity, objectivity or impartiality of their 
conformity assessment activities. 
5. Conformity assessment bodies  and their personnel shall carry out the conformity 
assessment activities with the highest degree of professional integrity and the requisite technical competence in the spec ific field and shal l be free from all 
pressures and inducements, particularly financial, which might influence their 
judgement or the results of their conform ity assessment activitie s, especially as 
regards persons or groups of persons with an interest in the results of those activities. 
6. A conformity assessment body shall be capable of carrying out all the conformity 
assessment tasks assigned to it by this Directive in relation to which it has been notified, whether those tasks are carried out  by the conformity assessment body itself 
or on its behalf and under its responsibility. 
At all times and for each conformity asse ssment procedure and each  kind or category 
of radio equipment in relation to which it has been notified, a conformity assessment 
body shall have at its di sposal the necessary: 
(a) personnel with technical knowledge and sufficient and appropriate experience 
to perform the conformity assessment tasks; 
(b) descriptions of procedures  in accordance with which conformity assessment is 
carried out, ensuring the transparency a nd the ability of reproduction of those 
procedures. It shall have appropriate policies and procedur es in place that 
distinguish between tasks it carries out as a notifi ed body and other activities; 
(c) procedures for the performance of activi ties which take due a ccount of the size 
of an undertaking, the sector in which it operates, its structure, the degree of 
complexity of radio equipment technol ogy in question and the mass or serial 
nature of the production process. 
It shall have the means nece ssary to perform the techni cal and administrative tasks 
connected with the conformity assessment  activities in an appropriate manner. 
7. The personnel responsible for carrying out  conformity assessment activities shall 
have the following: 
(a) sound technical and vocational training c overing all the conformity assessment 
activities in rela tion to which the conform ity assessment body has been 
notified;  
EN 33   EN (b) satisfactory knowledge of the requirements of the assessments they carry out 
and adequate authority to carry out those assessments; 
(c) appropriate knowledge and understanding of  the essential requirements set out 
in Article 3, of the applicable harm onised standards and of the relevant 
provisions of Union harmoni sation legislation and of  national legislation; 
(d) the ability to draw up certificates, r ecords and reports demonstrating that 
assessments have been carried out. 
8. The impartiality of the conformity assessment bodies, their top level management 
and of the assessment personnel shall be guaranteed. 
The remuneration of the top level mana gement and assessment personnel of a 
conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments. 
9. Conformity assessment bodies shall take out  liability insurance unless liab ility is 
assumed by the State in accordance with nati onal law, or the Member State itself is 
directly responsible for th e conformity assessment. 
10. The personnel of a conformity assessment  body shall observe professional secrecy 
with regard to all in formation obtained in carrying out their task s under this Directive 
or any provision of national law giving e ffect to it, except in relation to the 
competent authorities of the Member Stat e in which its activities are carried out. 
Proprietary rights shall be protected. 
11. Conformity assessment bodies shall particip ate in, or ensure that their assessment 
personnel are informed of, the relevant st andardisation activiti es, the re gulatory 
activities in the area of radio equipment and frequenc y planning, and th e activities of 
the notified body coordination group esta blished under the relevant Union 
harmonisation legislation and apply as gene ral guidance the administrative decisions 
and documents produced as a resu lt of the work of that group. 
Article 27 
Presumption of conformity of conformity assessment bodies 
Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in the relevant harmonised standards or parts thereof the references of which have been 
published in the Official Journal of the European Union  it shall be presumed to comply with 
the requirements set out in Article 26 in so fa r as the applicable harm onised standards cover 
those requirements. 
Article 28 
Subsidiaries of and subcontrac ting by notified bodies 
1. Where a notified body subcontracts speci fic tasks connected with conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or  
EN 34   EN the subsidiary meets the requirements set out in Article 26 and shall inform the 
notifying authority accordingly. 
2. Notified bodies shall take full res ponsibility for the tasks performed by 
subcontractors or subsidiaries wh erever these are established. 
3. Activities may be subcontracted or ca rried out by a subsid iary only with the 
agreement of the client. 
4. Notified bodies shall keep at the disposal  of the notifying authority the relevant 
documents concerning the assessment of the qua lifications of the subcontractor or the 
subsidiary and the work carried out by them under this Directive. 
Article 29 
Application for notification 
1. A conformity assessment body shall submit an application for notification to the 
notifying authority of the Member State in which it is established. 
2. That application shall be accompanied by a description of the conformity assessment 
activities, the c onformity assessment module or m odules and categories of radio 
equipment for which that body claims to be competent, as well as by an accreditation 
certificate, where one exists , issued by a national accred itation body attes ting that the 
conformity assessment body fulfils the re quirements laid down in Article 26. 
3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and regular monitoring of its compliance 
with the requirements laid down in Article 26. 
Article 30 
Notification procedure 
1. Notifying authorities may notify only conformity assessment bodies which have 
satisfied the requirements laid down in Article 26. 
2. They shall notify the Commission and the ot her Member States using the electronic 
notification tool developed and managed by the Commission. 
3. The notification shall include  full details of the conformity assessment activities, the 
conformity assessment module or modules and categories of the radio equipment 
concerned and the relevant attestation of competence. 
4. Where a notification is not based on an accreditation certificate as referred to in 
Article 29(2), the notifying authority sh all provide the Commission and the other 
Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangement s in place to ensure that that body 
will be monitored regularly and will continue  to satisfy the requirements laid down in 
Article 26.  
EN 35   EN 5. The body concerned may perform the activ ities of a notifie d body only where no 
objections are raised by th e Commission or the other Me mber States within two 
weeks of a notification wher e an accreditation certificate is used or within two 
months of a notification wher e accreditation is not used. 
Only such a body shall be considered a notified body for the purposes of this 
Directive. 
6. The Commission and the other Member Stat es shall be notified of any subsequent 
relevant changes to the notification. 
Article 31 
Identification numbers and lists of notified bodies 
1. The Commission shall assign an iden tification number to a notified body. 
It shall assign a single such number even  where the body is notified under several 
Union acts. 
2. The Commission shall make publicly availa ble the list of th e bodies notified under 
this Directive, including the identification num bers that have been allocated to them 
and the activities for which they have been notified. 
The Commission shall ensure that that list is kept up to date. 
Article 32 
Changes to notifications 
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Article 26, or th at it is fail ing to fulfil 
its obligations, the notifying au thority shall restrict, suspe nd or withdraw notification 
as appropriate, depending on the serious ness of the failure to meet those 
requirements or fulfil those obligations. It shall immediately inform the Commission 
and the other Member States accordingly. 
2. In the event of restriction, suspension or  withdrawal of notification, or where the 
notified body has ceased its activity, the notifying Member State shall take 
appropriate steps to ensure that the files of that body are either processed by another 
notified body or kept available for the re sponsible notifying and market surveillance 
authorities at their request. 
Article 33 
Challenge of the competence of notified bodies 
1. The Commission shall investigate all cases  where it doubts, or doubt  is brought to its 
attention regarding the competence of a no tified body or the continued fulfilment by 
a notified body of the requirements and responsibilities to wh ich it is subject.  
EN 36   EN 2. The notifying Member State shall provide  the Commission, on request, with all 
information relating to the basis for the notification or the maintenance of the competence of the body concerned. 
3. The Commission shall ensure that all sens itive information obtained in the course of 
its investigations is treated confidentially. 
4. Where the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for its notification, it  shall inform the notifying Member State 
accordingly and request it to take the n ecessary corrective measures, including de-
notification if necessary. 
Article 34 
Operational obligations of notified bodies 
1. Notified bodies shall carry out conformity assessments in accordance with the 
conformity assessment procedures pr ovided for in Annexes IV and V. 
2. Conformity assessments shall be carried  out in a proportionate manner, avoiding 
unnecessary burdens for economic operators . Conformity assessment bodies shall 
perform their activities taking due account of  the size of an undertaking, the sector in 
which it operates, its struct ure, the degree of complexity  of the product technology in 
question and the mass or serial na ture of the production process. 
In so doing they shall nevertheless respect  the degree of rigour and the level of 
protection required for the co mpliance of radio equipment with this Directive. 
Where a notified body finds th at the essential re quirements set out in Article 3 or 
corresponding harmonised standards or techni cal specifications have not been met by 
a manufacturer, it shall require that manuf acturer to take appr opriate corrective 
measures and shall not issue a conformity certificate. 
3. Where, in the course of the monitori ng of conformity following the issue of a 
certificate, a notified body finds that radio equipment no longer complies, it shall 
require the manufacturer to take appropriate  corrective measures and shall suspend or 
withdraw the certific ate if necessary. 
4. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, suspend or withdraw any cer tificates, as appropriate. 
Article 35 
Appeal against decisions of notified bodies 
Member States shall ensure that  an appeal procedur e against decisions of  the notified bodies 
is available.  
EN 37   EN Article 36 
Information obligation on notified bodies 
1. Notified bodies shall inform the no tifying authority of the following: 
(a) any refusal, restriction, suspension or withdrawal of  a certificate; 
(b) any circumstances affecting the scope of and conditions for notification; 
(c) any request for information which they ha ve received from market surveillance 
authorities regarding confor mity assessment activities; 
(d) on request, conformity assessment activit ies performed within the scope of 
their notification and a ny other activity performe d, including cross-border 
activities and subcontracting. 
2. Notified bodies shall provide the other bodi es notified under this Directive carrying 
out similar conformity assessment activitie s covering the same categories of radio 
equipment with relevant information on i ssues relating to negative and, on request, 
positive conformity assessment results. 
3. Notified bodies shall fulfil informatio n obligations under Annexes IV and V. 
Article 37 
Exchange of experience 
The Commission shall provide for the organisati on of exchange of experience between the 
Member States' national authorities responsible for notification policy. 
Article 38 
Coordination of notified bodies 
The Commission shall ensure that appropriate  coordination and coope ration between bodies 
notified under this Directive are put in place an d properly operated in th e form of a sectoral 
group of notified bodies. 
Member States shall ensure that  the bodies notified by them participate in the work of that 
group, directly or by means of designated representatives.  
EN 38   EN CHAPTER  V 
UNION  MARKET  SURVEILLANCE,  CONTROL  OF PRODUCTS  
ENTERING  THE  UNION  MARKET  AND  SAFEGUARD  PROCEDURES 
Article 39 
Union market surveillance and control of  products entering the Union market 
Article 15(3) and Articles 16 to  29 of Regulation (EC) No  765/2008 shall apply to radio 
equipment.  
Article 40 
Procedure for dealing with radio equipmen t presenting a risk at national level 
1. Where the market surveillance authoritie s of one Member State have taken action 
pursuant to Article 20 of  Regulation (EC) No 765/2008, or where they have 
sufficient reason to believe that radio equi pment covered by this Directive presents a 
risk to the health or safety of persons or to other aspects of public interest protection 
covered by this Directive, they shall carry  out an evaluation in relation to the radio 
equipment concerned covering all the require ments laid down in this Directive. The 
relevant economic operators shall coope rate as necessary with the market 
surveillance authorities. 
Where, in the course of th at evaluation, the market surv eillance authorities find that 
the radio equipment does not comply with the requirements laid down in this Directive, they shall without  delay require the relevant economic operator to take all 
appropriate corrective action to bring the radio equipment into compliance with those requirements, to withdraw the radio equipmen t from the market, or to recall it within 
a reasonable period, commensurat e with the nature of the ri sk, as they may prescribe. 
The market surveillance authorities sh all inform the relevant notified body 
accordingly. 
Article 21 of Regulation (EC) No 765/2008 shal l apply to the measur es referred to in 
the second subparagraph. 
2. Where the market surveillance authoritie s consider that non-compliance is not 
restricted to their national territory, they shall inform the Commission and the other Member States of the results of the eval uation and of the actions which they have 
required the economic operator to take. 
3. The economic operator shall ensure that al l appropriate correctiv e action is taken in 
respect of all radio equipmen t concerned that it has made  available on the market 
throughout the Union.  
EN 39   EN 4. Where the relevant economic operator do es not take adequate corrective action 
within the period referred to in the sec ond subparagraph of paragraph 1, the market 
surveillance authorities shall take all appr opriate provisional measures to prohibit or 
restrict radio equipment being made availabl e on their national market, to withdraw 
radio equipment from that market or to recall it. 
The market surveillance au thorities shall inform the Commission and the other 
Member States, without delay, of those measures. 
5. The information referred to in paragraph 4 shall include all available details, in 
particular the data necessary for the identification of the non-compliant radio 
equipment, the origin of radio equipment, the nature of the non-compliance alleged and the risk involved, the nature and durati on of the national measures taken and the 
arguments put forward by the relevant econom ic operator. In particular, the market 
surveillance authorities shall indicate wh ether the non-compliance is due to any of 
the following: 
(a) failure of radio equipment to  meet requirements relating to the health or safety 
of persons or to other asp ects of public interest protection laid down in this 
Directive;  
(b) shortcomings in the harmonised standards referred to in Article 16 conferring a 
presumption of conformity. 
6. Member States other than the Member State initiating the procedure shall without 
delay inform the Commission and the other Member States of any measures adopted 
and of any additional informa tion at their disposal rela ting to the non-compliance of 
radio equipment concerned, and, in the ev ent of disagreement with the notified 
national measure, of their objections. 
7. Where, within 8 weeks of receipt of the information referred to in paragraph 4, no 
objection has been raised by either a Member  State or the Commission in respect of a 
provisional measure taken by a Member St ate, that measure shall be deemed 
justified. 
8. Member States shall ensure that appropriate  restrictive measures are taken in respect 
of the apparatus concerned without delay. 
Article 41 
Union safeguard procedure 
1. Where, on completion of the procedure set out in Articles 40(3) and 40(4), objections 
are raised against a measur e taken by a Member State, or where the Commission 
considers a national measure to be contra ry to Union legisla tion, the Commission 
shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall eval uate the national measure. On the basis 
of the results of that evaluation, the Comm ission shall decide whether the national 
measure is justified or not.  
EN 40   EN The Commission shall addre ss its decision to all Me mber States and shall 
immediately communicate it to them a nd the relevant economic operator or 
operators. 
2. If the national measure is considered justified, all Member States shall take the 
measures necessary to ensure that the non-compliant radio equipment is withdrawn 
or recalled from their market, and shall inform the Commission accordingly. If the 
national measure is considered unjustif ied, the Member State concerned shall 
withdraw the measure. 
3. Where the national measure is considered  justified and the non-compliance of the 
radio equipment is attributed to shortcomi ngs in the harmonised standards referred to 
in Article 16 of this Directive, the Co mmission shall apply the procedure provided 
for in Article [8] of Regulation (EU)No [../..] [on European  Standardisation]. 
Article 42 
Compliant radio equipment which presen ts a risk to health and safety 
1. Where, having performed an evaluation under Article 40(1), a Member State finds 
that although radio equipment is  in compliance with this Di rective, it presents a risk 
to the health or safety of persons or to other aspects of public  interest protection 
covered by this Directive it sh all require the relevant ec onomic operator to take all 
appropriate measures to ensure that the radio equipment concerned, when placed on 
the market, no longer presents that risk, to  withdraw the radio equipment from the 
market or to recall it within  a reasonable period, commensur ate with the nature of the 
risk, as it may prescribe. 
2. The economic operator shall ensu re that corrective action is taken in respect of all the 
radio equipment concerned.  
3. The Member State shall immediately info rm the Commission and the other Member 
States. That information shall include all av ailable details, in particular the data 
necessary for the identification of the radi o equipment concerned, the origin and the 
supply chain of radio equipment, the nature of the risk involved and the nature and 
duration of the national measures taken. 
4. The Commission shall without delay enter in to consultation with the Member States 
and the relevant economic operator or op erators and shall ev aluate the national 
measures taken. On the basis of the result s of that evaluation, the Commission shall 
decide whether the measure is justif ied or not, and where necessary, propose 
appropriate measures. 
5. The Commission shall addre ss its decision to all Me mber States and shall 
immediately communicate it to them a nd the relevant economic operator or 
operators. 
Article 43 
Formal non-compliance  
EN 41   EN 1. Without prejudice to Article 40, where a Member State makes one of the following 
findings, it shall require th e relevant economic operator to put an end to the non-
compliance concerned: 
(a) the CE marking has been affixed in viol ation of Article 30 of Regulation (EC) 
No 765/2008 or of Article 19 or 20 of this Directive; 
(b) the CE marking has not been affixed; 
(c) the EU declaration of conformity has not been drawn up; 
(d) the EU declaration of conformity  has not been drawn up correctly; 
(e) technical documentation is either  not available or not complete; 
(f) product does not comply with the requirements set out in Articles 10(5), (6) 
and 12(3); 
(g) information on intended use of radio equi pment, EU declaration of conformity 
and usage restrictions as  set out in Article 10(7) , (8) and (9) does not 
accompany radio equipment; 
(h) requirements on identification of economi c operators set out in article 15 are 
not fulfilled; 
(i) non compliance with Article 5. 
2. Where the non-compliance referred to in paragraph 1 persists, the Member State 
concerned shall take all appr opriate measures to restri ct or prohibit corresponding 
radio equipment being made available on the ma rket or ensure that it is recalled or 
withdrawn from the market. 
CHAPTER  VI 
THE  COMMITTEE,  IMPLEMENTING  ACTS  AND  DELEGATED  ACTS 
Article 44 
Committee procedure 
1. The Commission shall be assisted by the Telecommunication Conformity 
Assessment and Market Surveillance Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 
2. Where reference is made to this para graph, Article 4 of Regulation (EU) No 
182/2011 shall apply.  
EN 42   EN Article 45 
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in  this Article.  
2. The delegation of power referred to in Ar ticles 2(3), 3(3), 4(2)  and 5(2) shall be 
conferred for an indeterminate period of time from the [date of entry into force] 
3. The delegation of power referred to in Articles 2(3), 3(3), 4(2) and 5(2) may be 
revoked at any time by the European Par liament or by the Council. A decision of 
revocation shall put an end to the delegation of the power specified in that decision. 
It shall take the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.  
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 
5. A delegated act adopted pursuant to Articles 2(3), 3(3), 4(2) and 5( 2) shall enter into 
force only if no objection has been expresse d either by the European Parliament or 
the Council within a period of two months of  notification of that act to the European 
Parliament and the Council or if, before the expiry of that period, the European 
Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European 
Parliament or the Council. 
CHAPTER  VII 
FINAL  AND  TRANSITIONAL  PROVISIONS 
Article 46 
Penalties 
Member States shall lay down rules on penaltie s applicable to infringements of the national 
provisions adopted pursuant to this  Directive and shall take all measures necessary to ensure 
that they are enforced.  
The penalties provided for shall be eff ective, proportionate and dissuasive.  
Member States shall notify those provisions to the Commission by [insert date – the date set 
out in the second subpa ragraph of Article Transposition(1) ] at the latest and shall notify it 
without delay of any subsequent amendment affecting them. 
Article 47 
Review and reporting  
EN 43   EN 1. Member States shall send the Commission regular reports on the application of this 
Directive by [date, - three y ears after the entry into force of this Directive] and at 
least every two years thereafter. The report shall contain a presen tation of the market 
surveillance activities performed by the Memb er States and provide information on 
whether and to what extent compliance with  the requirements of this Directive has 
been attained, including in particular requirements on identification of economic 
operators. 
2. The Commission shall review the operation of this Dire ctive and report thereon to 
the European Parliament and to the Council,  by [date - 4 years after the entry into 
force of this Directive] and every five years thereafter. The report shall cover 
progress on drawing up the re levant standards, as well as any problems that have 
arisen in the course of implementation. The report shall also outli ne the activities of 
the Committee, assess progress in achievi ng an open competitive market for radio 
equipment at Union level and examine how the regulatory framework for the placing 
on the market and putting into  service of radio equipmen t should be developed in 
order to achieve the following: 
(a) ensure that a coherent system is achieved at Union level for all radio 
equipment; 
(b) allow for convergence of the telecommuni cations, audiovisual and information 
technology sectors; 
(c) enable harmonisation of regulatory m easures at international level. 
It shall in particular examin e whether essential requirements  are still necessary for all 
categories of radio equipment covered. Where necessary, further measures may be proposed 
in the report for full implementation of the aim of this Directive. 
Article 48 
Transitional provisions  
Member States shall not impede the making av ailable on the market and/or putting into 
service of radio equipment covered by Directiv e 1999/5/EC which is in conformity with that 
Directive and which was placed on the market before [date set out in the second subparagraph of Article Transposition(1)].  
Article 49 
Transposition 
1. Member States shall adopt and publish, by [i nsert date - 18 months  after adoption] at 
the latest, the laws, regulations and admini strative provisions necessary to comply 
with this Directive. They shall forthwith communicate to the Commission the text of 
those provisions. 
They shall apply those provisions from [d ay after the date set out in the first 
subparagraph].  
EN 44   EN When Member States adopt t hose provisions, they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the directive repealed by this Directive 
shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.  
2. Member States shall communicate to the Commission the texts of the main 
provisions of national laws which they adopt  in the field covered by this Directive. 
Article 50 
Repeal 
Directive 1999/5/EC is repealed with effect from [date set out  in the second subparagraph of 
Article Transposition(1) of this Directive].  
References to the repealed Directive shall be construed as references to this Directive and 
shall be read in accordance with the correlation table in Annex IX.   
Article 51 
Entry into force 
This Directive shall enter into force on the tw entieth day following that  of its publication in 
the Official Journal of  the European Union . 
Article 52  
Addressees 
This Directive is addressed to the Member States. 
EN 45   EN ANNEX I  
EQUIPMENT NOT COVERED BY THIS DIRECTIVE  
1. Radio equipment used by radio amateurs within Article 1, de finition 56, of the 
International Telecommunications Uni on (ITU) radio regulations unless the 
equipment is available commercially. 
Kits of components to be assembled by ra dio amateurs and commercial equipment 
modified by and for the use of radio amat eurs are not regarded as commercially 
available equipment. 
2. Marine equipment falling within th e scope of Council Directive 96/98/EC36. 
3. Cabling and wiring. 4. Test equipment exclusively intended for the testing of radio equipment by 
professional users. 
5. Aeronautical products, parts and applianc es within the meani ng of Article 3 of 
Regulation (EC) No 216/2008 of the Eur opean Parliament and of the Council
37. 
                                                 
36 OJ L 46, 17.2.1997, p. 25 
37 OJ L 79, 19.3.2008, p. 1  
EN 46   EN ANNEX II  
PRODUCTS FALLING WITHIN THE DEFINITION OF RADIO EQUIPMENT 
1. For the purposes of this Directive the follo wing products shall be deemed to be radio 
equipment: 
(a) active antennas; 
(b) jammers. 
2. For the purposes of this Di rective the following products sh all not be deemed to be 
radio equipment: 
(a) passive antennas; 
(b) cochlear implants; 
(c) microwave ovens.  
EN 47   EN ANNEX III  
CONFORMITY ASSESSMENT  
Module A (internal production control) 
1. Internal production control is the conf ormity assessment procedure whereby the 
manufacturer fulfils the obligations laid  down in points 2, 3 and 4, and ensures and 
declares on his sole res ponsibility that radio equipm ent concerned satisfies the 
requirements set out in Article 3 and where applicable other harmonisation 
legislation applying to them. 
2. Technical documentation 
The manufacturer shall establish the technical documentation according to Article 
21.  
3. Manufacturing 
The manufacturer shall take all measures n ecessary so that the manufacturing process 
and its monitoring ensure compliance of th e manufactured radio equipment with the 
technical documentation referred to in poi nt 2 and with the relevant essential 
requirements in Article 3. 
4. CE marking and declaration of conformity 4.1. The manufacturer shall affix the required CE marking according to Articles 19 and 
20 to each piece of radio equipment that satisfies the applicable requirements. 
4.2. The manufacturer shall draw  up a written declaration of  conformity for each radio 
equipment type and keep it together with the technical documentation at the disposal 
of the national authorities for 10 years af ter radio equipment has been placed on the 
market. The declaration of conformity shall identify theradio equipment for which it 
has been drawn up. 
A copy of the declaration of conformity sh all be made available to the relevant 
authorities upon request. 
5. Authorised representative 
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised 
representative, on his behalf  and under his responsibility,  provided that they are 
specified in the mandate.  
EN 48   EN ANNEX IV  
CONFORMITY ASSESSMENT MODULES 
Modules B + C 
EU-Type examination + Conformity to type  based on internal production control 
When reference is made to this Annex, the conformity assessment procedure shall follow 
Modules B (EU-Type examination) and C (Confor mity to type based on internal production 
control) below.  
Module B 
EU-type examination 
1. EU-type examination is the part of a c onformity assessment procedure in which a 
notified body examines the technical desi gn of radio equipment and verifies and 
attests that the technical design of radi o equipment meets the requirements of the 
legislative instrument that apply to it. 
2. EU-type examination shall be carried out in the following manner: 
assessment of the adequacy of the tech nical design of radio equipment through 
examination of the technical documentati on and supporting evidence referred to in 
point 3, without examination of a specimen (design type). 
3. The manufacturer shall lodge an applica tion for EU-type examination with a single 
notified body of his choice. 
The application shall include: 
– the name and address of the manufacture r and, if the application is lodged by 
the authorised representative, his name and address as well, 
– a written declaration that the same a pplication has not been lodged with any 
other notified body, 
– the technical documentation. The tech nical documentation shall make it 
possible to assess radio equipment' s conformity with the applicable 
requirements of the legislative instru ment and shall include an adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture a nd operation of radio equipment. The 
technical documentation shall contain, wh erever applicable, the elements in 
Annex V to this Directive, 
– the supporting evidence for the adequacy of the technical design solution. This 
supporting evidence shall mention any doc uments that have been used, in 
particular where the relevant harm onised standards and/or technical 
specifications have not been applied in full. The supporting evidence shall 
include, where necessary, the results of tests carried out by the appropriate  
EN 49   EN laboratory of the manufactur er, or by another testing laboratory on his behalf 
and under his responsibility. 
4. The notified body shall examine the technical documentation and supporting 
evidence to assess the adequacy of th e technical design of radio equipment; 
5. The notified body shall draw up an evalua tion report that reco rds the activities 
undertaken in accordance with point 4 and their outcomes. Without prejudice to its 
obligations as provided in paragraph 8 below, the notified body shall release the 
content of that report, in fu ll or in part, only with the agreement of the manufacturer. 
6. Where the type meets the requirements of  the specific legislative instrument that 
apply to radio equipment concerned, the notified body shall issue an EU-type examination certificate to the manufacturer . The certificate shall contain the name 
and address of the manufacturer, the conc lusions of the examination, the conditions 
(if any) for its validity and the necessary data for identification of the assessed type. The certificate may have one or more annexes attached. 
The certificate and its annexes shall contai n all relevant information to allow the 
conformity of manufactured radio equipment with the examined type to be evaluated 
and to allow for in-service control. 
Where the type does not satisfy the applicable requirements of the legislative 
instrument, the notified body shall refuse to  issue an EU-type examination certificate 
and shall inform the applicant accordingly, gi ving detailed reasons for its refusal. 
7. The notified body shall keep itself appris ed of any changes in the generally 
acknowledged state of the art which indica te that the approved type may no longer 
comply with the applicable requirements of the legislative instrument, and shall 
determine whether such changes require furt her investigation. If  so, the notified body 
shall inform the manufacturer accordingly. 
The manufacturer shall inform the no tified body that hold s the technical 
documentation relating to the EU-type examina tion certificate of all modifications to 
the assessed type that may affect the c onformity of radio equipment with the 
essential requirements of the legislative instrument or the conditions for validity of the certificate. Such modifications shall re quire additional approval in the form of an 
addition to the original EU-t ype examination certificate. 
8. Each notified body shall inform its notif ying authorities con cerning the EU-type 
examination certificates and/or any add itions thereto which it has issued or 
withdrawn, and shall, periodi cally or upon request, make available to its notifying 
authorities the list of certificates and/or any additions thereto refused, suspended or 
otherwise restricted. 
Each notified body shall inform the othe r notified bodies concerning the EU-type 
examination certificates and/or any addi tions thereto which it has refused, 
withdrawn, suspended or otherwise rest ricted, and, upon request, concerning the 
certificates and/or additions thereto which it has issued. 
Each notified body shall inform Member Stat es of EU-type examination certificates 
it has issued and/or additions thereto in those cases where harmonised standards, the  
EN 50   EN reference of which have been published in  the Official Journal of the European 
Union, are available and have not been fully applied. The Member States, the 
Commission and the other notified bodies may, on request, obtain a copy of the EU-
type examination certificates and/or additi ons thereto. On request, the Member States 
and the Commission may obtain a copy of the technical documentation and the 
results of the examinations  carried out by the notifie d body. The notified body shall 
keep a copy of the EU-type examination certif icate, its annexes and additions, as well 
as the technical file including the documentation submitted by the manufacturer for a period of 10 years afte r radio equipment has been assesse d or until the expiry of the 
validity of the certificate. 
9. The manufacturer shall keep a copy of the EU-type examination certificate, its 
annexes and additions together with the t echnical documentation at the disposal of 
the national authorities for 10 years after radio equipment has been placed on the 
market. 
10. The manufacturer's authorised representativ e may lodge the application referred to in 
point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. 
Module C 
Conformity to type based on internal production control 
1. Conformity to type based on internal produc tion control is the part of a conformity 
assessment procedure whereby the manufactur er fulfils the obligations laid down in 
points 2 and 3, and ensures and declares th at radio equipments concerned are in 
conformity with the type described in the EU-type examination certificate and satisfy the requirements of the legislativ e instrument that apply to them. 
2. Manufacturing 
The manufacturer shall take all measures n ecessary so that the manufacturing process 
and its monitoring ensure conformity of the manufactured radio equipment with the 
approved type described in the EU-type  examination certificate and with the 
requirements of the legislative in strument that apply to them. 
3. CE marking and declaration of conformity 3.1. The manufacturer shall affix the CE marki ng according to Articl es 19 and 20 to each 
piece of radio equipment that is in conform ity with the type described in the EU-type 
examination certificate and satisfies the a pplicable requirements of the legislative 
instrument. 
3.2. The manufacturer shall draw  up a written declaration of  conformity for each radio 
equipment type and keep it at the dispos al of the national au thorities for 10 years 
after radio equipment has been placed on the market. The EU declaration of 
conformity shall identify the radio equipm ent type for which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant 
authorities upon request.  
EN 51   EN 4. Authorised representative 
The manufacturer's obligations set out in point 3 may be fulfilled by his authorised 
representative, on his behalf  and under his responsibility,  provided that they are 
specified in the mandate. 
ANNEX V  
CONFORMITY ASSESSMENT  
Module H 
Full Quality Assurance 
1. Conformity based on full quality assurance is the conformity assessment procedure 
whereby the manufacturer fulfils the oblig ations laid down in points 2 and 5, and 
ensures and declares on his sole respons ibility that radio equipment concerned 
satisfies the requirements of the legisl ative instrument that apply to them. 
2. Manufacturing 
The manufacturer shall operate an approve d quality system for design, manufacture 
and final product inspection and testing of ra dio equipment concerned as specified in 
point 3 and shall be subject to su rveillance as specified in point 4. 
3. Quality system 3.1. The manufacturer shall lodge an application for assessme nt of his quality system 
with the notified body of his choi ce, for radio equipment concerned. 
The application shall include: – the name and address of the manufacture r and, if the application is lodged by 
the authorised representative, his name and address as well, 
– the technical documentation for one type  of each category of radio equipment 
intended to be manufactured. The tech nical documentation shall contain, 
wherever applicable, the elements in Annex VI to this Directive, 
– the documentation concerning the quality system, and 
– a written declaration that the same a pplication has not been lodged with any 
other notified body. 
3.2. The quality system shall ensure comp liance of radio equipment with the 
requirements of the legislative in strument that apply to them. 
All the elements, requirements and provision s adopted by the manufacturer shall be 
documented in a systematic and orderly ma nner in the form of written policies, 
procedures and instructions. That quali ty system documentation shall permit a 
consistent interpretation of the quality programmes, plans, manuals and records. 
It shall, in particular, contai n an adequate description of:  
EN 52   EN – the quality objectives and the organisa tional structure, responsibilities and 
powers of the management with re gard to design and product quality, 
– the technical design specifications, incl uding standards, that will be applied 
and, where the relevant harmonised standa rds and/or technical  specifications 
will not be applied in full, the means th at will be used to ensure that the 
essential requirements of this Directive that apply to radio equipments will be met, 
– the design control and design verification techniques, processes and systematic 
actions that will be used when designing radio equipment pertaining to radio equipment category covered, 
– the corresponding manufacturing, quali ty control and quality assurance 
techniques, processes and systematic actions that will be used, 
– the examinations and tests that will be  carried out before, during and after 
manufacture, and the frequency with which they will be carried out, 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports on the personnel concerned, etc., 
– the means of monitoring the achieveme nt of the required design and product 
quality and the effective operation of the quality system. 
3.3. The notified body shall assess the quality sy stem to determine wh ether it satisfies the 
requirements referred to in  point 3.2 of this Annex. 
It shall presume conformity w ith those requirements in respect of the elements of the 
quality system that comply with the co rresponding specifications of the national 
standard that implements the relevant  harmonised standard and/or technical 
specification. 
In addition to experience in quality mana gement systems, the auditing team shall 
have at least one member experienced as an  assessor in the relevant radio equipment 
field and radio equipment technology con cerned, and knowledge of the applicable 
requirements of the legislativ e instrument. The audit shall include an assessment visit 
to the manufacturer's premises. The audi ting team shall review the technical 
documentation referred to in point 3.1, sec ond indent, to verify the manufacturer's 
ability to identify the applicable requireme nts of the legislative instrument and to 
carry out the necessary examinations with  a view to ensuring compliance of radio 
equipment with those requirements. 
The manufacturer or his aut horised representative shall be notified of the decision. 
The notification shall cont ain the conclusions of th e audit and the reasoned 
assessment decision. 
3.4. The manufacturer shall undert ake to fulfil the obligations arising out of the quality 
system as approved and to maintain it so  that it remains adequate and efficient.  
EN 53   EN 3.5. The manufacturer shall keep  the notified body that has approved the quality system 
informed of any intended change to the quality system. 
The notified body shall evalua te any proposed changes and decide whether the 
modified quality system will continue to sa tisfy the requirements referred to in point 
3.2 or whether a reassessment is necessary. 
It shall notify the manufacturer of its de cision. The notification shall contain the 
conclusions of the examination a nd the reasoned assessment decision. 
4. Surveillance under the res ponsibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. 
4.2. The manufacturer shall, for assessmen t purposes, allow the notified body access to 
the design, manufacture, inspection, testi ng and storage sites, and shall provide it 
with all necessary info rmation, in particular: 
– the quality system documentation, 
– the quality records as provided for by th e design part of the quality system, 
such as results of analyses, calculations, tests, etc., 
– the quality records as provided for by th e manufacturing part of the quality 
system, such as inspection reports and test data, calibration data, qualification 
reports on the personnel concerned, etc. 
4.3. The notified body shall carry ou t periodic audits to make sure that the manufacturer 
maintains and applies the quality system a nd shall provide the ma nufacturer with an 
audit report. 
4.4. In addition, the notified body may pay unexpect ed visits to the manufacturer. During 
such visits, the notified body may, if necessary, carry out radio equipment tests, or 
have them carried out, in order to check th e proper functioning of the quality system. 
It shall provide the manufacturer with a vi sit report and, if test s have been carried 
out, with a test report. 
5. CE marking and declaration of conformity 5.1. The manufacturer shall affix the CE ma rking according to Articles 19 and 20 and, 
under the responsibility of the notified body referred to in point 3.1, the latter's 
identification number to each piece of radio equipment that satisfies the applicable 
requirements set out in Article 3. 
5.2. The manufacturer shall draw up a written EU  declaration of conformity for each type 
of radio equipment and keep it at the dis posal of the national authorities for 10 years 
after radio equipment has been placed on the market. The EU declaration of 
conformity shall identify the radio equipm ent type for which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant 
authorities upon request.  
EN 54   EN 6. The manufacturer shall, fo r a period ending at least 10 years after radio equipment 
has been placed on the market, keep at th e disposal of the national authorities: 
– the technical documentation referred to in point 3.1, 
– the documentation concerning the qualit y system referred to in point 3.1, 
– the change referred to in point 3.5, as approved, 
– the decisions and reports of the notif ied body referred to in points 3.5, 4.3 and 
4.4. 
7. Each notified body shall inform its notifying authorities of quality system approvals 
issued or withdrawn, and shall, periodical ly or upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or 
otherwise restricted. 
Each notified body shall inform the other not ified bodies of quality  system approvals 
which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. 
8. Authorised representative 
The manufacturer's obligations set out in  points 3.1, 3.5, 5 and 6 may be fulfilled by 
his authorised representative, on his behalf  and under his responsibility, provided that 
they are specified in the mandate. 
. 
EN 55   EN ANNEX VI  
Contents of Technical Documentation 
The technical documentation shall, wherever applicable, contain at least the following 
elements: 
(a) a general description of th e radio equipment including: photographs or illustrations 
showing external features, marking and in ternal layout; versions  of software or 
firmware affecting compliance with essent ial requirements; user information and 
installation instructions; 
(b) conceptual design and manu facturing drawings and schemes of components, sub-
assemblies, circuits and other relevant similar elements; 
(c) descriptions and explanations  necessary for the understand ing of those drawings and 
schemes and the operation of the radio equipment; 
(d) a list of the harmonised standards and/or ot her relevant technical specifications the 
references of which have been published in the Official Journal of the European 
Union , applied in full or in part, and descriptio ns of the solutions adopted to meet the 
essential requirements in Article 3 where those harmonised standards have not been applied; in the event of partly appl ied harmonised standards, the technical 
documentation shall specify the parts which have been applied; 
(e) copy of the EU declaration of conformity; 
(f) where the conformity assessment module in Annex IV has been applied, copy of the 
EU-type examination certificate and its anne xes as delivered by the involved notified 
body; 
(g) results of design calculations made, exam inations carried out, and other relevant 
similar elements; 
(h) test reports.  
EN 56   EN ANNEX VII  
Declaration of Conformity  
1. No … (unique identification of the radio equipment): 
2. Name and address of the manufacturer  or his authorised representative: 
3. This declaration of confor mity is issued under the sole responsibility of the 
manufacturer. 
4. Object of the declaration (identification of the radio equipment allowing traceability. 
It may include a photograph, where appropriate): 
5. The object of the declaration described a bove is in conformity with the relevant 
European Union harmonisation legislation: 
Radio Equipment Directive XXXX/xx Other European Union harmonisation legislation where applicable 
6. References to the relevant harmonised standards used or references to the 
specifications in relation to which conformity is declared. References shall be listed with their identification number and versi on and where applicable date of issue: 
7. Where applicable, the notified body ... (n ame, number) … performed … (description 
of intervention) … and issued the EU-type examination certificate: … 
8. Additional information: 
Where applicable, description of accessories  and/or components, including software, 
which allow the radio equipment to ope rate as intended and covered by the 
Declaration of Conformity 
Signed for and on behalf of: ………………………………… (place and date of issue): (name, function) (signature):  
EN 57   EN ANNEX VIII  
Simplified Declaration of Conformity  
The simplified EU declaration of conformity re ferred to in the third subparagraph of Article 
10(8) shall be provided as follows:  
Hereby, [Name of manufacturer] de clares that the radio equipmen t type [designation of type 
of radio equipment] is in compliance with Radio Equipment Directive XXXX/xx.  
EN 58   EN ANNEX IX 
Correlation table 
CORRELATION TABLE  
Directive 1999/5/EC  This Directive  
Article 1 Article 1 
Article 2 Article 2 Article 3 Article 3, with the exception 
of Article 3(3)(g) 
Article 4(1) Article 8 Article 4(2) deleted 
Article 5 Article 16 
Article 6(1) Article 6 Article 6(2) deleted 
Article 6(3) Article 10(7), 10(8), 10(9) 
Article 6(4) deleted 
Article 7(1), 7(2) Article 7 
Article 7(3), 7(4), 7(5) deleted 
Article 8 Article 9 
Article 9 Articles 39-43 Article 10 Article 17 Article 11 Articles 22-38 Article 12 Articles 19, 20, 10(5), 10(6) Articles 13 to 15 Article 44 Article 16 deleted 
Article 17 Article 47 
Article 18 Article 48 Article 19 Article 49 Article 20 Article 50 
Article 21 Article 51 
Article 22 Article 52 Annex I Annex I  
EN 59   EN Annex II Annex III 
Annex III deleted 
Annex IV Annex IV 
Annex V Annex V 
Annex VI Article 26 
Annex VII(1) to (4) Articles 19, 20 
Annex VII(5) Article 10(9) New Articles Article 3(3)(g)  Article 4  Article 5  Articles 10(1) to (4), 10(10), 
10(11), Articles 11 to 15 
 Article 18  Article 21  Article 45  Article 46  Annex II  Annex VI  Annex VII  Annex VIII  
EN 60   EN  
LEGISLATIVE FINANCIAL STATEMENT   
EN 61   EN 1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1.  Title of the proposal/initiative:  1.2.  Policy area(s) concerned in the ABM/ABB structure  1.3.  Nature of the proposal/initiative:  1.4.  Objective(s):  
1.4.1. The Commission's multiannual strategic obj ective(s) targeted by the proposal:  
1.4.2. Specific objective(s) and ABM/ABB activity(ies) concerned 
1.5.  Grounds for the proposal/initiative:  
1.6.  Duration and financial impact:  1.7.  Management method(s) envisaged:  
2. MANAGEMENT
 MEASURES   
2.1.  Monitoring and reporting rules  2.2.  Management and control system  2.3.  Measures to prevent fraud and irregularities 
3. ESTIMATED
 FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1.  Heading(s) of the multiannual fina ncial framework and expenditure budget 
line(s) affected:  
3.2.  Estimated impact on expenditure  3.2.1.  Summary of estimated impact on expenditure  
3.2.2.  Estimated impact on ope rational appropriations  
3.2.3.  Estimated impact on appropriations  of an administrative nature:  
3.2.4.  Compatibility with the current  multiannual financial framework 
3.2.5.  Third-party participation in financing  
3.3.  Estimated impact on revenue  
EN 62   EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a Directive of the European  Parliament and of the Council on the 
harmonisation of the laws of the Member States relating to radio equipment (the Radio 
Equipment Directive), and repealing Di rective 1999/5/EC, Directive on Radio and 
Telecommunications Terminal Equipment, the R&TTE Directive 
1.2. Policy area(s) concerned in the ABM/ABB structure38  
Title 2 – Enterprise – Chapter 02 03: Internal  Market for Goods and Sectoral Policies 
1.3. Nature of the proposal/initiative  
 The proposal/initiative relates to  a new action   
 The proposal/initiative relates to a new action following a pilot project/preparatory 
action39  
X The proposal/initiative relates to the extension of an existing action   
 The proposal/initiative relates to an action redirected towards a new action   
1.4. Objectives 
1.4.1. The Commission's multiannual strategic objecti ve(s) targeted by the proposal/initiative  
1.4.2. Specific objective(s) and ABM /ABB activity(ies) concerned  
Specific objective No .1. 
To continually renew existing internal ma rket acquis and propose new legislative or 
non-legislative action whenever appropriate [IP, IU, DA]. See 1.5.1 below for further 
detail. 
ABM/ABB activity(ies) concerned  
02 03 
1.4.3. Expected result(s) and impact 
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 
                                                 
38 ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
39 As referred to in Article 49(6)(a) or (b) of the Financial Regulation.  
EN 63   EN The proposed legislative revisi on is expected to increase compliance of radio equipment 
with the essential requirements in the Directive, namely the protection of health and 
safety, electromagnetic compatibility, and th e avoidance of harmful interference. It 
should therefore improve protect ion of users and of fair co mpetition, to bring increased 
legal certainty, smoother and more consistent  application of the Directive and more 
comprehensive prevention of harmful interfer ence, with limited additional burden for 
market operators 
1.4.4. Indicators of results and impact  
Specify the indicators for monitoring implementation of the proposal/initiative. 
Core indicators of progress towards meeti ng the objectives for the revision of the 
Directive are the following: 
 Indicator Approach 
Compliance Administrative and technical 
compliance ratios Periodic reports from 
Member States 
Administrative simplification and legal adaptations Induced administrative cost 
and burden, number and relative relevance of issues of interpretation Regular exchange with 
stakeholders — economic operators, authorities and notified bodies 
Regulatory barriers to innovation Perceived simplicity of 
introducing innovations Regular exchange with 
stakeholders 
In accordance with the proposal, Member States would have a new obligation to send to 
the Commission biannual reports on the applicat ion of the Directive. The reports should 
cover market surveillance activities perfor med and provide inform ation on the level of 
compliance with the essential requir ements laid down in the Directive 
Further information is to be collected through regular exchanges within TCAM, the 
standing committee set up by the Directive, whic h in addition to Member States includes 
representatives from industry, European Standards Organisa tions, Notified Bodies and 
consumer organisations. The Co mmission plans to review the operation of this Directive 
and report thereon to the Eur opean Parliament and to the Council every five years. 
1.5. Grounds for the proposal/initiative  
1.5.1. Requirement(s) to be met in the short or long term  
The Directive has been essential to achieve a single market for radio equipment and for 
telecommunication terminals. It includes esse ntial requirements for the protection of 
health and safety and for the prevention of harmful interference. These requirements are 
translated into technical re quirements within non-mandatory harmonised standards, as in 
other ‘New Approach’ legislation. 
The regulatory approach is considered to remain valid, a fundamental revision of the 
Directive is therefore not necessary; Nevert heless, experience in the operation of the  
EN 64   EN Directive has highlighted a numbe r of issues to be addressed40. The main objectives of 
the draft proposal are: 
- to redress the current situation of low level of compliance with the requirements in the 
Directive, and to increase the confidence of all stakeholders in the regulatory 
framework, 
- to clarify and simplify the Directive including some limited adaptations of scope so as 
to facilitate its app lication and eliminate unnecessary burden for economic operators and 
public authorities. 
1.5.2. Added value of EU involvement 
The revised Directive is to be based on Articles 26 (Internal Market) and 114 
(Approximation of Laws) TFEU. Action at EU level is necessary in order to adapt, 
clarify or simplify provisions which are the ke ystone of the Single Market in this area. 
This cannot be achieved by Member Stat es acting individua lly. A possible new 
obligation to register at EU level manufactur ers and/or equipment would enable access 
to the EU market, and its advantages compared  to multiple similar measures at national 
level are clear 
1.5.3. Lessons learned from sim ilar experiences in the past 
Overall, the regulatory fram ework set up by the Directive has allowed to achieve its 
intended goals, i.e. a high le vel of protection of  health and safety  for users, the 
electromagnetic compatibility (EMC) for telecommunication terminals and radio 
equipment as well as the avoidance of harm ful interference. The main issues to be 
addressed are the low level of compliance with the Directive and the ambiguity and 
complexity of some provi sions in the Directive. 
1.5.4. Coherence and possible synergy wi th other relevant instruments 
The proposed revision will be consistent with the principles of the Commission’s ‘Smart 
Regulation’ policy, with the policy for Eu rope 2020, in particular as regards the 
regulatory review foreseen within the polic y for an Innovation Union , as well as with 
the proposed Radio Spectrum Policy Programme . 
The initiative will also be consistent w ith the New Legislative Framework package 
approved in 2008. This consists of two complementary instruments, Regulation 
765/2008 on accreditation and market surveillan ce and Decision 768/2008 establishing a 
common framework for the marketing of products. The Decision complements the 
Regulation. While the latter basically sets out the obligations on Member States and 
their authorities to ensure th at products on their market are safe and comply with the 
legal requirements, the Decision deals w ith the relevant obligations imposed on 
economic operators such as manufacturers, im porters and distributor s, as well as the 
bodies testing and certifying products. Henc e, the two instruments are inextricably 
linked and their elements mutually support and complement each other. Unlike the 
Regulation, the Decision doe s not have immediate legal effects on economic operators, 
                                                 
40 Second Progress Report on the operation of the R&TTE Directive, COM(2010)43 final, of 9.2.2010  
EN 65   EN individuals or Member St ates, and provides (Artic le 2) that its provisions are to be used 
when legislation is drafted or revised. 
1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
–  Proposal/initiative in effect fr om [DD/MM]YYYY to [DD/MM]YYYY  
–  Financial impact from YYYY to YYYY  
X Proposal/initiative of unlimited duration  
– Implementation with a start-up period from 2013  
– followed by full-scale operation. 
1.7. Management mode(s) envisaged41  
1.8. X  Centralised direct management by the Commission  
 Centralised indirect management  with the delegation of implementation tasks to: 
–  executive agencies  
–  bodies set up by the Communities42  
–  national public-sector bodies/bodies with public-service mission  
–  persons entrusted with the implementation of specific actions pursuant to Title V 
of the Treaty on European Union and identified in the relevant basic act within the meaning of Article 49 of the Financial Regulation  
 Shared management with the Member States  
 Decentralised management with third countries   
 Joint management with international organisations (to be specified) 
If more than one management mode is indicated, pl ease provide details in the "Comments" section. 
Comments 
                                                 
41 Details of management modes and references to the Financial Regulation may be found on the BudgWeb 
site: http://www.cc.cec/budg/man/budgm anag/budgmanag_en.html  
42 As referred to in Article 185 of the Financial Regulation.  
EN 66   EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions. 
In accordance with the proposal, Member Stat es would have a new obligation to send 
to the Commission biannual reports on the ap plication of the Dire ctive. The reports 
should cover market surveillance activities performed and provide information on the 
level of compliance with the essential requirements laid down in the Directive.  
Further information is to be collected through regular exchange s within TCAM, the 
standing committee set up by the Directive, which in addition to Member States 
includes representatives from industry, Eur opean Standards Organisations, Notified 
Bodies and consumer organisations. The Co mmission plans to review the operation 
of this Directive and report thereon to the European Pa rliament and to the Council 
every five years. 
2.2. Management and control system  
2.2.1. Risk(s) identified  
-Divergent implementation of the revised Directive by Member States might become 
an issue.  
-EU-level expenses associated to the revised Directive are limited to human 
resources and possibly to the creation of  a database for registration of some 
categories of products prior to their placi ng on the market where following the entry 
into force of the revised Directive a high level of compliance has not been achieved.  
2.2.2. Control method(s) envisaged  
-In order to facilitate the transposition of the Directive in a way which is consistent 
across Member States and with the intention of the EU legislator, the Commission 
plans to organise one or more workshops with responsible national ministries during 
the period provided for transposition of the Directive by Member States. 
-The possible set-up of database for the registration of products for an estimated 
budget of 300000 EUR would be subject to tend ering under the rules of the Financial 
Regulation.  
2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection measures. 
-No specific measures beyond the applic ation of the Financial Regulation  
EN 67   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financ ial framework and expenditure budget 
line(s) affected  
• Existing expenditure budget lines  
Budget line  Type of  
expenditureContribution  
Heading of 
multiannual 
financial 
framework Number  
[Description………………………...…
…….]  Diff./non-
diff. 
(43) from 
EFTA44 
countries from 
candidate 
countries45 from third 
countries within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  
1a 
Competitiven
ess for 
growth and 
employment 02.03.01,  
Operation and development of the 
internal market, particularly in the fields 
of notification, certification and sectoral 
approximation. Diff. NO NO NO NO 
• New budget lines requested: NO 
In order  of multiannual financial framework headings and budget lines. 
Budget line  Type of 
expenditureContribution  
Heading of 
multiannual 
financial 
framewor k Number  
[Heading……………………………………..]  Diff./non-
diff. from 
EFTA 
countries from 
candidate 
countries from third 
countries within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  
 [XX.YY.YY.YY] 
  YES/N
O YES/N
O YES/N
O YES/NO 
                                                 
43 Diff. = Differentiated appropriations / Non- diff. = Non-Differentiated Appropriations 
44 EFTA: European Free Trade Association.  
45 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 68   EN 3.2. Estimated impact on expenditure  
3.2.1. Summary of estimated impact on expenditure  
EUR million (to 3 decimal places) 
Heading of multiannual financial 
framework:  Number  1a. Competitiveness for gr owth and employment  
 
DG: ENTR    Year 
N46 Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  TOTAL 
y Operational appropriations          
Commitments (1) 0 0 0 0.3 0.03 0.03 0.03  Proposal of 
unlimited duration  02.03.01,  
Operation and development of the internal 
market, particularly in the fields of 
notification, certification and sectoral 
approximation. Payments (2) 0 0 0 0.3 0.03 0.03 0.03  Proposal of 
unlimited duration  
Commitments (1a)         Number of budget line  Payments (2a)         
Appropriations of an administrative nature financed 
 from the envelope for specific programmes47          
Number of budget line   (3)         
TOTAL appropriations Commitments =1+1a 
+3 0 0 0 0.3 0.03 0.03 0.03  Proposal of 
unlimited duration  
                                                 
46 Year N is the year in which implem entation of the proposal/initiative starts. 
47 Technical and/or administrative assistance and expenditure in su pport of the implementation of EU programmes and/or actions (f ormer "BA" lines), indirect research, direct 
research.  
EN 69   EN for DG ENTR  
Payments =2+2a 
+3 0 0 0 0.3 0.03 0.03 0.03  Proposal of 
unlimited duration  
 
Commitments (4)         y TOTAL operational appropriations  
Payments (5)         
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6 0 0 0 0.3 0.03 0.03 0.03  Proposal of 
unlimited duration  TOTAL appropriations  
under HEADING 1a. Competitiveness 
for growth and employment of the 
multiannual financial framework  Payments =5+ 6 0 0 0 0.3 0.03 0.03 0.03  Proposal of 
unlimited duration  
If more than one heading is affected by the proposal / initiative: NO  
Commitments (4)         y TOTAL operational appropriations  
Payments (5)         
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6         TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount)  Payments =5+ 6         
  
EN 70   EN  
Heading of multiannual financial 
framework:  5 " Administrative expenditure "  
 
   Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  TOTAL 
DG: ENTR  
y Human resources  0.635 0.635 0.635 0.635 0.635 0.635 0.635 Proposal of 
unlimited duration 
y Other administrative expenditure  0.092 0.092 0.092 0.092 0.092 0.092 0.092 Proposal of 
unlimited duration  
TOTAL DG ENTR Appropriations  0.727 0.727 0.727 0.727 0.727 0.727 0.727  Proposal of 
unlimited duration  
 
TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework   (Total commitments 
= Total payments)          
EN 71   EN 3.2.2. Estimated impact on opera tional appropriations  
–  The proposal/initiative does not requir e the use of operational appropriations  
– X The proposal/initiative requires the use of ope rational appropriations, as explained below: 
Commitment appropriations in EU R million (to 3 decimal places) 
  Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as necessary to show 
the duration of the impact (see point 1.6)  TOTAL  
OUTPUTS  Indicate 
objectives and 
outputs  
 
Ø Type 
of 
output
48 Avera
ge 
cost  
of the 
output 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost 
Number 
of outputs Cost Tota
l 
num
ber 
of 
outp
uts Total  
cost 
SPECIFIC OBJECTIVE No 1: To 
continually renew existing 
internal market acquis and 
propose new legislative or 
non-legislative action 
whenever appropriate 49…                 
Delivery of an 
IT database for 
product 
registration         1 0.3         
                                                 
48 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc .). 
49 As described in Section 1.4.2. "Specific objective(s)…"  
EN 72   EN Maintenance of 
an IT database 
for product 
registration           1 0.03 1 0.03 1 0.03  Proposal 
of 
unlimited 
duration  
-  O u t p u t                    
Sub-total for specific objective N°1                 
SPECIFIC OBJECTIVE No 2…                 
-  O u t p u t                    
Sub-total for specific objective N°2                 
TOTAL COST         0.3  0.03  0.03  0.03  Proposal 
of 
unlimited 
duration  
  
EN 73   EN 3.2.3. Estimated impact on appropriations  of an administrative nature 
3.2.3.1. Summary  
–  The proposal/initiative does not require th e use of administrative appropriations  
– X The proposal/initiative requires the use of administrative appropriations, as 
explained below: 
EUR million (to 3 decimal places) 
 
Year 
N 50 Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as necessary 
to show the duration of the impact 
(see point 1.6)  TOTAL 
 
HEADING 5 
of the multiannual 
financial framework         
Human resources  0.635 0.635 0.635 0.635 0.635 0.635 0.635 Proposal of 
unlimited 
duration 
Other administrative 
expenditure  0.092 0.092 0.092 0.092 0.092 0.092 0.092  
Subtotal HEADING 5 
of the multiannual 
financial framework  0.727 0.727 0.727 0.727 0.727 0.727 0.727 Proposal of 
unlimited 
duration  
 
Outside HEADING 551 
of the multiannual 
financial framework          
H u m a n  r e s o u r c e s           
Other expenditure  
of an administrative nature         
Subtotal  
outside HEADING 5 
of the multiannual 
financial framework          
 
TOTAL  0.727 0.727 0.727 0.727 0.727 0.727 0.727 Proposal of 
unlimited 
duration
                                                 
50 Year N is the year in which implem entation of the proposal/initiative starts. 
51 Technical and/or administrative assistance and expenditure in support of the implementation of EU 
programmes and/or actions (former "BA" li nes), indirect research, direct research.  
EN 74   EN 3.2.3.2.  Estimated requirements of human resources  
–  The proposal/initiative does not require the use of human resources  
– X The proposal/initiative requires the us e of human resources, as explained 
below: 
Estimate to be expressed in full amounts (or at most to one decimal place) 
 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as 
necessary to show the 
duration of the impact 
(see point 1.6)  
y Establishment plan posts (officials and temporary agents)  
02 01 01 01 (Headquarters and Commission’s 
Representation Offices)  5 5 5 5 5 5 5 
XX 01 01 02 (Delegations)        
XX 01 05 01 (Indirect research)        
10 01 05 01 (Direct research)        
y External personnel (in Full Time Equivalent unit: FTE)52 
XX 01 02 01 (CA, INT, SNE from the "global 
envelope")         
XX 01 02 02 (CA, INT, JED, LA and SNE in the 
delegations)        
- at Headquarters54        
XX 01 04 yy 53 
- in delegations         
XX 01 05 02 (CA, INT, SNE - Indirect research)        
10 01 05 02 (CA, INT, SNE - Direct research)        
Other budget lines (specify)        
TOTAL  5 5 5 5 5 5 5 
 
XX is the policy area or budget title concerned. 
The human resources required will be met by staff from the DG who are already assigned to 
management of the action and/or have been rede ployed within the DG, together if necessary with 
any additional allocation which may be grante d to the managing DG unde r the annual allocation 
procedure and in the light of budgetary constraints. 
Description of tasks to be carried out: 
Officials and temporary agents 1 official as desk officer of the Directive, 3 officials in charge of specific areas: legal 
issues, secretariat of the St anding Committee, communication, coordination with DG 
Information Society on Spectrum Policy, assessm ent of Member States notifications of 
                                                 
52 CA= Contract Agent; INT= agency staff (" Intérimaire") ; JED= " Jeune Expert en Délégation" (Young Experts 
in Delegations); LA= Local Agent; SNE= Seconded National Expert;  
53 Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
54 Essentially for Structural Funds , European Agricultural Fund for Rural Development (EAFRD) and European 
Fisheries Fund (EFF).  
EN 75   EN relevant technical regulations, coordination of enforcement by market surveillance 
authorities, screening of legislation by EU candidate/associated countries, support to 
DG Trade on negotiations with third countries 
-1 official as secretary of the team and responsible for logistics 
External personnel   
EN 76   EN  
3.2.4. Compatibility with the current multiannual financial framework  
– X Proposal/initiative is compatible the current multiannual financial 
framework: all measures or actions includ ed in this Directive are consistent and 
compatible with the current  and the next multiannual fi nancial framework (2014 to 
2020) as proposed by the Commission. 
–  Proposal/initiative will enta il reprogramming of the relevant heading in the 
multiannual financial framework. 
Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 
–  Proposal/initiative requires a pplication of the flex ibility instrument or revision of the 
multiannual financial framework55. 
Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 
3.2.5. Third-party contributions  
– X The proposal/initiative does not provide for co-financing by third parties  
– The proposal/initiative provides for the co-financing estimated below: 
Appropriations in EUR m illion (to 3 decimal places) 
 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  Total 
Specify the c o-financing 
body          
TOTAL appropriations 
cofinanced          
3.3. Estimated impact on revenue  
– X Proposal/initiative has no financial impact on revenue. 
–  Proposal/initiative has the following financial impact: 
•  on own resources  
•  on miscellaneous revenue  
EUR million (to 3 decimal places)  
Budget revenue line: AppropriationImpact of the proposal/initiative56 
                                                 
55 See points 19 and 24 of the Interinstitutional Agreement.  
EN 77   EN s available for 
the ongoing 
budget year Year 
N Year 
N+1 Year 
N+2 Year 
N+3 … insert as many columns as necessary 
in order to reflect the duration of the 
impact (see point 1.6)  
Article ………….         
For miscellaneous assigned revenue, specify  the budget expenditure line(s) affected. 
Specify the method for calcula ting the impact on revenue.   
                                                                                                                                                                 
56 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 25% for collection costs.