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
Date: 2012-10-17
Institutions: European Commission
Subjects: Community certification, EC conformity marking, electronic device, market approval, market supervision, marketing standard, quality standard, radio telecommunications, technical standard, traceability

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} 

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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 Parliament and of the Council 
of  9  March  1999  on  radio  equipment  and  telecommunications  terminal  equipment  and  the 
mutual recognition of their conformity, establishes a framework for the placing on the market, 
free movement and putting into service 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  for  the  protection  of  health  and  safety,  of 
electromagnetic  compatibility  and  for  the  avoidance  of  harmful  interference.  These 
requirements  are  translated  into  technical  requirements  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. Nevertheless, 
experience  in  the  operation  of  the  Directive  has  highlighted  a  number  of  issues  to  be 
addressed1. 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 stakeholders 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  integrate  the  Directive  with  other  related  EU 
legislation  managed  by  DGConnect,  in  particular  the  Radio  Spectrum  Decision2.  The 
proposed text is built on the alignment of the 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  the  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  States  may  not  introduce  further  restrictions 
addressing at national level the same requirements, namely the protection of health and safety, 
electromagnetic  compatibility,  and  the  avoidance  of  harmful  interference.  Other  EU 
legislation on environmental aspects also applies to these products, in particular the Directives 

1 
2 

Second Progress Report on the operation of the R&TTE Directive, COM(2010)43 final, of 9.2.2010 
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 

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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  policy  set  out  in  the  Radio  Spectrum 
Policy Programme7; 

General  criteria  laid  down  in  Directive  2002/21/EC  (Framework  Directive8) 
within the regulatory framework for electronic communications; 

Conditions  for  authorisations  for  the  use  of  spectrum  laid  down  in  Directive 
2002/20/EC  (Authorisation  Directive9)  within  the  regulatory  framework  for 
electronic communications; 

Implementing  measures  under  Decision  676/2002/EC  (Radio  Spectrum 
Decision10)  harmonising  the  technical  conditions  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 policies and objectives of the Union. 

The  proposal  is  consistent  with  the  principles  of  the  Commission’s  ‘Smart  Regulation’ 
policy11,  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 and market surveillance and of Decision 
768/2008  establishing  a  common  framework  for  the  marketing  of  products.  The  Decision 
provides (Article 2) that its provisions are to be used when legislation is drafted or revised. 

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5 
6 

7 

8 

9 

10 

11 
12 

13 

Directive 2002/95/EC on Restriction of Hazardous Substances. 
Directive 2002/96/EC on Waste of Electrical and Electronic Equipment. 
Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators. 
Directive 2009/125/EC establishing a framework for the setting of ecodesign requirements for energy-
related products.  
Decision  No  243/2012/EU  of  the  European  Parliament  and  of  the  Council  of  14  March  2012 
establishing a multiannual radio spectrum policy programme. 
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) 
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)  
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) 
http://ec.europa.eu/governance/better_regulation/key_docs_en.htm#_br. 
http://ec.europa.eu/research/innovation-union/index_en.cfm,  COM(2010)  546  final,  Europe  2020 
Flagship Initiative - Innovation Union. 
Decision  No  243/2012/EU  of  the  European  Parliament  and  of  the  Council  of  14  March  2012 
establishing a multiannual radio spectrum policy programme. 

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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  included  in  the  Second  Progress  Report  on  the 
operation of the Directive14. 

The Commission conducted a further public consultation in 2010 focusing on the impact of 
some of the measures under consideration. The Commission received contributions from 122 
respondents,  including  50  SMEs,  36  other  economic  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 aligning the Directive with the New 
Legislative Framework package and for clarifying and simplifying the Directive. Opinions are 
more divided on the possible introduction of a requirement to register 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  adapt,  clarify  or  simplify  provisions  of  Internal 
Market  legislation  in  this  area.  The  proposal  harmonises  essential  and  administrative 
requirements  compliance  with  which  enables  access  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 objectives set. The new or modified obligations do 
not impose unnecessary burdens and costs on industry especially on small and medium sized 

14 

15 

16 

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. [COM/2010/0043 final - Not published in the Official 
Journal] - http://ec.europa.eu/enterprise/sectors/rtte/documents/legislation/review/index_en.htm#h2-2 
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 
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/rtte/files/technop-ia-radio-finrep_en.pdf 

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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 multiannual financial framework: all measures or 
actions included in the proposed directive are consistent 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  requiring  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  administered  by  the  Commission.  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  administrations  by  increasing  spectrum  flexibility 
and easing administrative procedures for spectrum use. It is part 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  review  the  operation  of  the  Directive  and  report 
thereon 4 years after the entry into force of the Directive and every five years thereafter 

•  Information from Member States 

Member States shall inform the Commission on the transposition of the Directive and send to 
the  Commission  a  report  on  its  application  three  years  after  the  entry  into  force  of  the 
Directive and every two years thereafter. 

•  European Economic Area 

The proposed act is of relevance to the EEA and should therefore extend thereto. 

•  Detailed explanation of the proposal 

The most significant elements of the proposal for a revision of the Directive are the following: 

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1. 

Alignment  with  Decision  768/2008/EC  on a  common  framework  for  the  marketing 
of products: 

– 

– 

– 

– 

– 

Article  2  includes  the  definitions  set  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 Annex II of Decision 768/2008/EC 

Articles  22-to-38  include  the  obligations  for  the  notification  of  conformity 
assessment bodies set out in chapter R4 of Decision 768/2008/EC 

Articles 39-to-43 include the simplified safeguard procedures set out in chapter 
R5 of Decision 768/2008/EC 

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  radio  spectrum,  whether  for  the  purpose  of 
communication  or  other.  The  essential  requirement  in  Article  3(2)  has  been 
correspondingly adapted and only refers to transmitted signals. 

In  consequence,  the  proposed  new  title  for  the  Directive  is:  “Directive  on  the 
harmonisation of the laws of the Member States relating to the making available on 
the market of radio equipment” 

Article  3(3)  (a)  makes  it  possible  to  require  radio  equipment  to  interoperate  with 
accessories such as chargers 

Article  3(3)  (g)  makes  it  possible  to  require  software-defined  radio  equipment  to 
ensure  that  only  compliant  combinations  of  software  and  hardware  come  together. 
Article  4  makes  it  possible  to  adopt  measures  to  avoid  that  this  regulatory 
requirement creates barriers to competition in the market for third-party software 

Article 5 introduces the possibility to require the registration 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) 

Article  7  clarifies  the  relation  between  the  R&TTE  Directive  and  EU  and  national 
legislation on the use of radio spectrum 

Simplification and reduction of administrative obligations:  

2. 

3. 

4. 

5. 

6. 

7. 

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– 

– 

– 

– 

– 

– 

The new definition of radio equipment set out in Article 2(1) establishes a clear 
demarcation of scope with Directive 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/EC18, or depending on their voltage 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  placing  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  the  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  Functioning  of  the  European  Union  and  with 
Regulation No 182/2011 on the Commission’s exercise of implementing powers: 

– 

– 

– 

The procedures for the exercise of implementing and delegated powers are laid 
out in Articles 44 (Committee procedure) and 45 (Exercise of the delegation) 

Implementing powers are proposed in Article 8(3) (determination of equipment 
classes) and Article 10(9) (presentation 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  essential  requirements),  Article  4(2) 
(provision  of  information  on  the  compliance  of  software-defined  radio 
equipment),  and  Article  5(2)  (requirement  to  register  radio  equipment  within 
some categories) 

17 

18 

19 

20 

Directive  2004/108/EC  of  the  European  Parliament  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 
Directive  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 limits 
Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general 
product safety  
Directive 2008/63/EC of 20 June 2008 on competition in the markets in telecommunications terminal 
equipment 

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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) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL 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 Committee21, 

After consulting the European Data Protection Supervisor22, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 
on  radio  equipment  and  telecommunications  terminal  equipment  and  the  mutual 
recognition of their conformity23 has been substantially amended several times. Since 
further amendments are to be made, it should be replaced in the interests of clarity.  

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accreditation 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 controls 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  marketing of products, and repealing Council 

21 
22 
23 
24 

EN 

OJ L 91, 7.4.1999, p. 10. 
OJ L 218, 13.8.2008, p. 30. 

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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. Directive 1999/5/EC should therefore be adapted 
to that Decision.  

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 appropriately covered by Directive 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 December 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. 

Competition issues in the market for terminal equipment are appropriately covered by 
Commission Directive 2008/63/EC of 20 June 2008 on competition in the markets in 
telecommunications  terminal  equipment28,  in  particular  through  the  obligation  for 
national regulatory authorities to ensure the publication of details of technical interface 
specifications  for  network  access.  It  is  therefore  not  necessary  to  include  in  this 
Directive  requirements  facilitating  competition  in  the  market  for  terminal  equipment 
covered by Directive 2008/63/EC.  

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 harmful interference, all such equipment should fall within the 
scope of this Directive, whether equipment is capable of communication or not. 

Experience has shown the difficulty of establishing whether some products fall within 
the scope of Directive 1999/5/EC. In particular, in respect of products resulting from 
technological  progress  and  presenting  difficulties  of  categorisation,  it  is  necessary  to 
identify  categories  of  products  which  fall  or  not  within  the  definition  of  radio 
equipment.  In  order  to  supplement  or  amend  certain  non-essential  elements  of  this 
Directive, the power to adopt 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 amendments of Annex II so as to adapt it to technical progress. 

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 Directive. In order to avoid unnecessary duplications 
of provisions, other than the essential requirements, Directive 2006/95/EC should not 
apply to radio equipment. 

(4) 

(5) 

(6) 

(7) 

(8) 

25 
26 
27 
28 

OJ L 218, 13.8.2008, p. 82. 
OJ L 374, 27.12.2006, p. 10. 
OJ L 390, 31.12.2004, p. 24. 
OJ L 162, 21.6.2008, p. 20. 

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(9) 

The essential requirements in the area of electromagnetic compatibility laid down by 
Directive  2004/108/EC  are  sufficient  to  cover  radio  equipment,  and  should  therefore 
be  the  reference  and  made  applicable  by  virtue  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, according to the state of the art, should be ensured 

so as to avoid harmful interference.  

(11)  Although  receivers  do  not 

interference,  reception 
capabilities are an increasingly important factor in ensuring the efficient use of radio 
spectrum  by  way  of  an  increased  resilience  of  receivers  against  interference  and 
unwanted signals on the basis of the essential requirements of Directive 2004/108/EC. 

themselves  cause  harmful 

(12)  Receiver  capabilities  of  receive-only  equipment  are  subject  to  the  essential 
requirements of Directive 2004/108/EC in particular 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 equipment within the scope of this Directive. 

(13) 

In some cases interworking via networks with other radio equipment and connection 
with  interfaces  of  the  appropriate  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  privacy  of  users  of  radio  equipment  and  the 
protection  from  fraud  may  be  enhanced  by  particular  features  of  radio  equipment. 
Radio equipment should therefore in appropriate 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 appropriate cases be designed in such a way that 
it supports those features required 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  proportion  of  the  population  of 
Member States. Radio equipment should therefore 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 radio 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 compromise the subsequent compliance of the 
radio equipment with the applicable essential requirements. 

(18) 

It  is  necessary  to  provide  for  a  possibility  to  introduce  supplementary  requirements 
addressing  needs  related  to  interoperability,  user  privacy,  fraud  prevention,  use  by 
users  with  a  disability,  access  to  emergency  services  or  the  prevention  of  non-
compliant  combinations  of  software  and  radio  equipment.  In  order  to  supplement  or 
amend  certain  non-essential  elements  of  this  Directive,  the  power  to  adopt  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 comply with additional essential requirements 

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on  interoperability,  user  privacy,  fraud  prevention,  use  by  users  with  a  disability, 
access  to  emergency  services  or  the  prevention  of  non-compliant  combinations  of 
software and radio equipment.  

(19)  Verification  by  radio  equipment  of  the  compliance  of  its  combination  with  software 
should not be abused in order to prevent its use with software provided by independent 
parties. The availability to public authorities, 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 Directive, the power to adopt 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  specifying  categories  or  classes  of  radio  equipment  for 
which  manufacturers  need  to  provide  information  on  the  compliance  of  intended 
combinations  of  radio  equipment  and  software,  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  level  of  compliance  with  the  Directive.  Such  a 
requirement  entails  additional  burden  to  economic  operators  and  should  therefore  be 
introduced  only  for  those  categories  of  radio  equipment  where  a  high  level  of 
compliance  has  not  been  attained.  In  order  to  supplement  or  amend  certain  non-
essential elements of this Directive, the power to adopt 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 identifying the relevant 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  specifying  the  information  to  be  registered,  the 
rules applicable for registration and affixation 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  applicable  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 equipment within the Internal 
Market  of  the  Union,  Member  States  should  notify  under  Directive  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  field  of  technical  standards  and  regulations29  to 
other  Member  States  and  to  the  Commission  their  projects  in  the  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 spectrum policy in the European Community30.  

(23)  The provision of information on the equivalence 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  assess  and  establish  the  equivalence  of 

29 
30 

OJ L 204, 21.7.1998, p. 37. 
OJ L 108, 24.4.2002, p. 1. 

EN 

11 

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those  regulated  radio  interfaces  and  make  available  such  information  in  the  form  of 
radio equipment classes. 

(24) 

information 

regarding  spectrum  use  within 

In  accordance  with  Commission  Decision  2007/344/EC  of  16  May  2007  on 
harmonised  availability  of 
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 placing 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 notification, allowing to inform manufacturers of 
the conditions of use of radio equipment 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, exhibitions 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 responsible for the compliance of products, in relation 
to their respective roles in the supply chain, so as to ensure a high level of protection 
of health and safety, of electromagnetic compatibility, an efficient use of spectrum so 
as  to  avoid  harmful  interference,  and  to  guarantee  fair  competition  on  the  Union 
market. 

(27)  All  economic  operators  intervening  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 which correspond to the role of each operator 
in the supply and distribution process. 

(28)  The manufacturer, having detailed knowledge of the design and production process, is 
best  placed  to  carry  out  the  complete  conformity  assessment  procedure.  Conformity 
assessment should therefore remain the obligation of the manufacturer alone. 

(29)  The  manufacturer  should  provide  sufficient  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  specifications  of  the  installation  process  of  the 
equipment. 

(30)  The  requirement  in  Directive  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. 

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(31) 

It is necessary to ensure that products from third countries entering the Union market 
comply  with  the  requirements  of  this  Directive,  and  in  particular  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 should 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 manufacturers are available for inspection by 
the supervisory authorities. 

(32)  The distributor makes radio equipment available on the market after it has been placed 
on  the  market  by  the  manufacturer  or  the  importer  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  market,  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  size  or  nature  of  the  equipment  does  not 
allow it. This includes cases where the importer would have to open the packaging to 
put his name and address on the radio equipment. 

(34)  Any  economic  operator  that  either  places  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  those  authorities  with  all  necessary 
information relating to the radio equipment concerned. 

(36)  Ensuring traceability of  radio  equipment throughout the whole supply chain helps to 
make market surveillance simpler and more efficient. An efficient traceability system 
facilitates  market  surveillance  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 those 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. […]. 

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13 

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(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 level of safety required. In order to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, conformity assessment procedures should be 
chosen from among those modules. 

(40)  Manufacturers  should  draw  up  an  EU  declaration  of  conformity  to  provide  detailed 
information  on  the  conformity  of  radio  equipment  with  the  requirements  of  this 
Directive and of the other relevant Union harmonisation legislation. 

(41)  The CE marking, indicating the conformity of a product, is the visible consequence of 
a  whole  process  comprising  conformity  assessment  in  a  broad  sense.  General 
principles  governing  the  CE  marking  are  set  out  in  Regulation  (EC)  No  765/2008. 
Rules governing the affixing of the CE marking 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 authorities. The possibility in Directive 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 requirement without reducing its effectiveness 
and should therefore be included in this Directive. 

(43)  The requirement in Directive 1999/5/EC to affix the CE marking on the packaging of 
equipment  has  been  found  to  simplify  the  task  of  market  surveillance  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  criteria  set  out  in  Directive  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  level  of  performance  of  notified  bodies 
throughout  the  Union.  It  is,  however,  essential  that  all  notified  bodies  perform  their 
functions to the same level and under conditions of fair competition. That requires the 
setting  of  obligatory  requirements  for  conformity  assessment  bodies  wishing  to  be 
notified in order to provide conformity assessment services. 

(46) 

(47) 

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. 

If a conformity assessment body demonstrates conformity with the criteria laid down 
in  harmonised  standards,  it  should  be  presumed  to  comply  with  the  corresponding 
requirements set out in this Directive. 

(48)  The  system  set  out  in  this  Directive  should  be  complemented  by  the  accreditation 
system  provided  for  in  Regulation  (EC)  No  765/2008.  Since  accreditation  is  an 
essential  means  of  verifying  the  competence  of  conformity  assessment  bodies,  it 
should also be used for the purposes of notification. 

EN 

14 

   EN 

 
(49)  Transparent  accreditation  as  provided  for  in  Regulation  (EC)  No  765/2008,  ensuring 
the necessary level of confidence in conformity 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  authorities,  they  should 
provide the Commission and the other Member States with the necessary documentary 
evidence demonstrating the compliance of the conformity assessment bodies evaluated 
with the relevant regulatory requirements. 

(50)  Conformity assessment bodies frequently subcontract parts of their activities linked to 
the  assessment  of  conformity  or  have  recourse  to  a  subsidiary.  In  order  to  safeguard 
the level of protection required 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  relation  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 monitoring of bodies already 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 technologies so as to enable online notification. 

(52)  Since notified bodies may offer their services throughout the Union, it is appropriate to 
give the other Member States and the Commission 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 competence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 

(53) 

In  the  interests  of  competitiveness,  it  is  crucial  that  notified  bodies  apply  the 
conformity assessment procedures without creating unnecessary burdens for economic 
operators. For the same reason, and to ensure equal treatment of economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to  be  ensured.  That  can  best  be  achieved  through  appropriate  coordination  and 
cooperation between notified bodies. 

(54) 

In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance  and  control  of  products  entering  the  Union  market  provided  for  in 
Regulation (EC) No 765/2008 apply to radio equipment. 

(55)  Directive 1999/5/EC already provides for a safeguard procedure 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  procedure,  with  a  view  to  making  it  more 
efficient and drawing on the expertise available in Member States. 

(56)  The  existing  system  should  be  supplemented  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 

15 

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market  surveillance  authorities,  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  Commission  agree  as  to  the  justification  of  a 
measure taken by a Member State, no further involvement of the Commission should 
be  required,  except  where  non-compliance  can  be  attributed  to  shortcomings  of  a 
harmonised standard. 

(58) 

(59) 

In  order  to  ensure  uniform  conditions  for  the  implementation  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 February 2011 laying down the rules and general 
principles concerning mechanisms for control byMember States of the Commission's 
exercise of implementing powers33.  

It is of particular importance that the Commission carry out appropriate consultations 
during  its  preparatory  work  of  delegated  acts,  including  at  expert  level.  The 
Commission,  when  preparing  and  drawing-up  delegated  acts,  should  ensure  a 
simultaneous,  timely  and  appropriate  transmission  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  this  Directive  and  ensure  that  they  are 
implemented. Those penalties should be effective, proportionate and dissuasive. 

(61) 

It is necessary to provide for transitional arrangements that allow making available on 
the market and putting into service radio equipment 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 level of protection of health and safety, of 
electromagnetic compatibility and an efficient use of spectrum so as to avoid harmful 
interference  while  guaranteeing  the  functioning  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 principle 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  corresponding  parts  of  national  transposition 
instruments. With regard to this Directive, the legislator considers the transmission of 
such documents to be justified. 

33 

OJ L 55 of 28.2.2011, p. 13. 

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HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER I 

GENERAL PROVISIONS 

Article 1 

Subject matter and scope 

1. 

2. 

3. 

4. 

1. 

(1) 

(2) 

(3) 

(4) 

(5) 

This  Directive  establishes  a  regulatory  framework  for  the  making  available  on  the 
market and putting into service in the Union of radio equipment. 

This Directive shall not apply to equipment listed in Annex I. 

This  Directive  shall  not  apply  to  radio  equipment  exclusively  used  for  activities 
concerning  public  security,  defence,  State  security,  including  the  economic  well-
being of the State in the case of activities pertaining to State security matters, and the 
activities of the State in the area of criminal law. 

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 

For the purpose of this Directive the following definitions shall apply: 

‘radio equipment’ means a product which intentionally 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; 

‘radio waves’ means electromagnetic waves of frequencies from 9 kHz to 3000 GHz, 
propagated in space without artificial guide; 

‘interface’ means an air interface specifying the radio path between radio equipment 
and their technical specifications; 

‘radio  equipment  class’  means  a  class  identifying  particular  categories  of  radio 
equipment which under this Directive are considered similar and those interfaces for 
which the equipment is designed; 

‘harmful 
2002/21/EC of the European Parliament and of the Council34; 

interference’  means  harmful 

interference  as  defined 

in  Directive 

34 

OJ L 108, 24.4.2002, p. 33. 

EN 

17 

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(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

‘making  available  on  the  market’  means  any  supply  of  radio  equipment  for 
distribution,  consumption  or  use  in  the  European  Union  market  in  the  course  of  a 
commercial activity, whether in return for payment or free of charge; 

‘placing on the market’ means the first making available of radio equipment on the 
European Union market; 

‘manufacturer’ means any natural or legal person who manufactures radio equipment 
or has radio equipment designed or manufactured, and markets that equipment under 
his name or trademark; 

‘authorised representative’ means 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; 

‘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; 

‘distributor’  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  the 
manufacturer or the importer, who makes radio equipment available on the market; 

‘economic  operators’  means  the  manufacturer,  the  authorised  representative,  the 
importer and the distributor; 

‘technical specification’ means a document that prescribes technical requirements to 
be fulfilled by radio equipment; 

‘harmonised  standard’  means  harmonised  standard  as  defined  in  Article  2(1)(c)  of 
Regulation (EU) No [../..] [on European Standardisation]35; 

(15) 

‘accreditation’ means accreditation as defined in Regulation (EC) No 765/2008; 

(16) 

(17) 

(18) 

(19) 

(20) 

(21) 

‘national  accreditation  body’  means  national  accreditation  body  as  defined  in 
Regulation (EC) No 765/2008; 

‘conformity  assessment’  means  the  process  demonstrating  whether  the  essential 
requirements relating to radio equipment have been fulfilled; 

‘conformity  assessment  body’  means  a  body  that  performs  conformity  assessment 
activities; 

‘recall’ means any measure aimed at achieving the return of radio equipment that has 
already been made available to the user; 

‘withdrawal’ means any measure aimed at preventing radio equipment in the supply 
chain from being made available on the market; 

‘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 

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(22) 

‘  Union  harmonisation  legislation’  means  any  Union  legislation  harmonising  the 
conditions for the marketing of products. 

2. 

3. 

For the purposes of point 1 of paragraph 1 of this Article, products listed under point 
1 of Annex II shall be deemed to be radio equipment, and products listed under point 
2 of Annex II shall not be deemed to be radio equipment.  

The  Commission  shall  be  empowered  to  adopt  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: 

2. 

3. 

(a) 

(b) 

the  protection  of  the  health  and  the  safety  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 voltage limit applying; 

the  protection  of  electromagnetic  compatibility  as  set  out  in  Directive 
2004/108/EC,  including  in  particular  levels  of  immunity  which  lead  to 
improvements in the efficient use of shared or adjacent frequency bands.  

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 radio 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. 

Radio equipment shall be so constructed that it complies with the following essential 
requirements:  

(a) 

(b) 

(c) 

radio equipment interworks with accessories, and/or it interworks via networks 
with  other  radio  equipment,  and/or  it  can  be  connected  to  interfaces  of  the 
appropriate type throughout the Union; 

radio  equipment  does  not  harm  the  network  or  its  functioning  nor  misuse 
network resources, thereby causing an unacceptable degradation of service; 

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 features ensuring avoidance of fraud; 

(e) 

(f) 

radio  equipment  supports  certain  features  ensuring  access  to  emergency 
services; 

radio equipment supports certain features in order to facilitate its use by users 
with a disability; 

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(g) 

radio equipment supports certain features in order to ensure that software can 
only  be  loaded  into  the  radio  equipment  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  radio  equipment  are  concerned  by  each  of  the 
requirements (a) to (g) in the first subparagraph.  

1. 

2. 

1. 

2. 

Article 4 

Provision of information on the compliance of combinations of software and radio 
equipment 

Manufacturers  of  radio  equipment  and  of  software  allowing  radio  equipment  to  be 
used  as  intended  shall  provide  the  Member  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. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 45 specifying which categories or classes of radio equipment are concerned 
by the requirement in the paragraph 1, the required information and the operational 
rules for making the information on compliance available. 

Article 5 

Registration of radio equipment within some categories  

As  from  [date  -  four  years  after  the  date  of  entry  into  force  of  the  Directive], 
manufacturers  shall  register  radio  equipment  types  within  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 the market. The Commission shall allocate to 
each registered type a registration number, which manufacturers shall affix on radio 
equipment placed on the market. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  45  specifying  which  categories  of  radio  equipment  are  concerned  by  the 
requirement  set  out  in  the  paragraph  1,  taking  into  account  information  on  the 
compliance  of  equipment  provided  by  Member  States  in  accordance  with  Article 
47(1), the information to be registered, the operational rules for registration and the 
operational rules for affixation of the registration number on radio equipment.  

3. 

The  Commission  shall  make  available  a  central  system  allowing  manufacturers  to 
register the required information.  

Article 6 

Placing on the market  

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Member  States  shall  ensure  that  radio  equipment  is  made  available  on  the  market  only  if  it 
complies  with  this  Directive  when  it  is  properly  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  obligations  under 
Decision  No  676/2002/EC,  and  to  the  conditions  attached  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  only  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 interference or matters relating to public health. 

1. 

2. 

3. 

1. 

2. 

Article 8 

Notification of interface specifications and radio equipment classes 

Member  States  shall  notify  in  accordance  with  the  procedure  set  out  in  Directive 
98/34/EC the interfaces which they intend to regulate.  

When  assessing  correspondence  between  radio  equipment  and  regulated  interfaces, 
Member States shall take into account the equivalence with radio interfaces notified 
by other Member States.  

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  implementing  acts  shall  be  adopted  in 
accordance with the advisory procedure referred to in Article 44(2). 

Article 9 

Free movement of radio equipment 

Member  States  shall  not  prohibit,  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.  

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  visible  sign  clearly  indicates  that  such  radio 
equipment may not be marketed or used until it has been made to comply. 

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CHAPTER II 

OBLIGATIONS OF ECONOMIC OPERATORS  

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Article 10 

Obligations of manufacturers 

When placing radio equipment on the market, manufacturers shall ensure that it has 
been  designed  and  manufactured  in  accordance  with  the  essential  requirements  set 
out in Article 3. 

Manufacturers  shall  draw  up  the  technical  documentation  referred  to  in  Article  21 
and carry out the conformity assessment procedure 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,  manufacturers  shall  draw  up  an  EU  declaration  of 
conformity and affix the CE marking. 

Manufacturers  shall  keep  the  technical  documentation  and  the  EU  declaration  of 
conformity for 10 years after radio equipment has been placed on the market. 

Manufacturers  shall  ensure  that  procedures  are  in  place  for  series  production  to 
remain  in  conformity.  Changes  in  radio  equipment  design  or  characteristics  and 
changes  in  the  harmonised  standards  or  in  technical  specifications  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  testing  of  radio  equipment  made  available  on 
the  market,  investigate,  and,  if  necessary,  keep  a  register  of  complaints,  of  non-
conforming radio equipment and radio equipment recalls, and shall keep distributors 
informed of any such monitoring. 

Manufacturers shall ensure that radio equipment bears a type, batch or serial number 
or  other  element  allowing  their  identification,  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. 

Manufacturers  shall  indicate  their  name,  registered  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 manufacturer can be contacted. 

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. Instructions shall include 
the information required to use radio equipment in accordance with its intended use. 

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Such information shall include, where applicable, a description of accessories and/or 
components,  including  software,  which  allow  the  radio  equipment  to  operate  as 
intended.  

The following information shall also be included: 

frequency band(s) in which the radio equipment operates; 

radio-frequency  power  transmitted  in  the  frequency  band(s)  in  which  the  radio 
equipment operates. 

A copy of the full EU declaration of conformity 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 declaration 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.  

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  potential  restrictions  or  requirements  for 
authorisation of use in certain Member States. Such information shall be completed 
in  the  instructions  accompanying  radio  equipment.  The  Commission  may  adopt 
implementing  acts  specifying  how  to  present  this  information.  Those  implementing 
acts shall be adopted in accordance with the advisory procedure referred to in Article 
44(2). 

Manufacturers  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  necessary  corrective  measures  to  bring  that  radio  equipment 
into conformity, to withdraw it or recall it, if appropriate. Furthermore, where radio 
equipment  presents  a  risk,  manufacturers  shall  immediately  inform  the  competent 
national  authorities  of  the  Member  States  in  which  they  made  radio  equipment 
available to that effect, giving details, in particular, of the non-compliance and of any 
corrective measures taken. 

Manufacturers  shall,  further  to  a  reasoned  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 shall 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. 

8. 

9. 

10. 

11. 

Article 11 

Authorised representatives 

1. 

A manufacturer may, by a written mandate, appoint an authorised representative.  

The  obligations  laid  down  in  Article  10(1)  and  the  drawing  up  of  technical 
documentation shall not form part of the authorised representative's mandate. 

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2. 

An  authorised  representative  shall  perform  the  tasks  specified  in  the  mandate 
the  authorised 
the  manufacturer.  The  mandate  shall  allow 
received  from 
representative to do at least the following: 

(a)  keep the EU declaration of conformity and the technical documentation at the 
disposal  of  national  surveillance  authorities  for  10  years  after  the  radio 
equipment has been placed on the market; 

(b) 

(c) 

further to a reasoned request from a competent national authority, provide that 
authority with all the information and documentation necessary to demonstrate 
the conformity of radio equipment; 

cooperate  with  the  competent  national  authorities,  at  their  request,  on  any 
action  taken  to  eliminate  the  risks  posed  by  radio  equipment  covered  by  the 
authorised representative’s mandate. 

Article 12 

Obligations of importers 

1. 

2. 

3. 

4. 

5. 

Importers shall place only compliant radio equipment on the market. 

Before  placing  radio  equipment  on  the  market  importers  shall  ensure  that  the 
the 
appropriate  conformity  assessment  procedure  has  been  carried  out  by 
manufacturer.  They  shall  ensure  that  the  manufacturer  has  drawn  up  the  technical 
documentation, that the radio equipment bears 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 has 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  presents  a  risk,  the  importer  shall  inform  the 
manufacturer and the market surveillance authorities to that effect. 

Importers  shall  indicate  their  name,  registered  trade  name  or  registered  trade  mark 
and the address at which they can be contacted 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 size of radio equipment does not allow it, 
or where importers would have to open the packaging in order to indicate their name 
and address on radio equipment. 

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. 

Importers  shall  ensure  that,  while  radio  equipment  is  under  their  responsibility, 
storage  or  transport  conditions  do  not  jeopardise  its  compliance  with  the  essential 
requirements set out in Article 3. 

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6. 

7. 

8. 

9. 

1. 

2. 

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  available  on  the  market,  investigate,  and,  if 
necessary,  keep  a  register  of  complaints,  of  non-conforming  radio  equipment  and 
radio equipment recalls, and shall keep distributors informed of such monitoring. 

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 radio equipment into conformity, 
to  withdraw  it  or  recall  it,  if  appropriate.  Furthermore,  where  the  radio  equipment 
presents a risk, importers 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. 

Importers shall, for a period of ten years after the radio equipment has been placed 
on the market, keep a copy of the EU declaration 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. 

Importers  shall,  further  to  a  reasoned  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 shall cooperate with 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 

When making radio equipment available on the market distributors shall act with due 
care in relation to the requirements of this Directive. 

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 other users in the Member State in which 
the radio equipment is to be made available on the market, and that the manufacturer 
and the importer have complied with the requirements 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 set 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  effect  as  well  as  the  market  surveillance 
authorities. 

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3. 

4. 

5. 

Distributors  shall  ensure  that,  while  radio  equipment  is  under  their  responsibility, 
storage  or  transport  conditions  do  not  jeopardise  its  compliance  with  the  essential 
requirements set out in Article 3.  

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 necessary 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. 

Distributors shall, further to a reasoned request from a competent national authority, 
provide  it  without  delay  with  all  the  information  and  documentation  necessary  to 
demonstrate  the  conformity  of  radio  equipment.  They  shall  cooperate  with  that 
authority,  at  its  request,  on  any  action  taken  to  eliminate  the  risks  posed  by  radio 
equipment which they have made available on the market. 

Article 14 

Cases in which obligations of manufacturers apply to importers and distributors 

An  importer  or  distributor  shall  be  considered  a  manufacturer  for  the  purposes  of  this 
Directive  and  he  shall  be  subject  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) 

(b) 

any economic operator who has supplied them with radio equipment; 

any economic operator to whom they have supplied radio equipment. 

Economic operators shall be able to present the information referred 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. 

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CHAPTER III 

CONFORMITY OF RADIO EQUIPMENT 

1. 

2. 

1. 

2. 

3. 

Article 16 

Presumption of conformity and harmonised standards 

Radio equipment which is in conformity with harmonised standards or parts thereof 
the references of which have been published in the Official Journal of the European 
Union shall be presumed to be in conformity with the essential requirements covered 
by those standards or parts thereof, set out in Article 3  

Where  a  harmonised  standard  satisfies  the  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 

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 conformity to type procedure set out in 
Annex IV; 

(c) 

 full quality assurance procedure set out in Annex V. 

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 conformity to type procedure set out in 

Annex IV; 

(c) 

full quality assurance procedure set out in Annex V. 

Where  in  assessing  the  compliance  of  radio  equipment  with  the  essential 
requirements identified in Articles 3(2) and (3), the manufacturer has not applied or 
has  applied  only  in  part  harmonised  standards  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 

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those  essential  requirements  to  the  procedure  set  out  in  either  of  the  following 
procedures: 

(a)  EU-type examination followed by the conformity to type procedure set out in 

Annex IV; 

(b) 

full quality assurance procedure set out in Annex V. 

Article 18 

EU declaration of conformity 

1. 

2. 

3. 

4. 

1. 

2. 

The  EU  declaration  of  conformity  shall  state  that  the  fulfilment  of  the  essential 
requirements set out in Article 3 has been demonstrated. 

The  EU  declaration  of  conformity  shall  have  the  model  structure  and  shall  contain 
the  elements  set  out  in  Annex  VII  and  shall  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 simplified EU declaration of conformity referred to in Article 10(8) shall contain 
the  elements  set  out  in  Annex  VIII  and  shall  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. 

Where  the  radio  equipment  is  subject  to  more  than  one  Union  act  requiring  an  EU 
declaration of conformity, a single EU declaration of conformity shall be drawn up in 
respect of all such Union acts. That declaration shall contain the identification of the 
acts concerned including the publication references. 

By  drawing  up  the  EU  declaration  of  conformity,  the  manufacturer  shall  assume 
responsibility for the compliance of radio equipment. 

Article 19 

General principles of the CE marking 

The  CE  marking  shall  be  subject  to  the  general  principles  set  out  in  Article  30  of 
Regulation (EC) No 765/2008.  

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 

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1. 

2. 

3. 

The CE marking shall be affixed visibly, legibly 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 affixed visibly and legibly 
to the packaging. 

The CE marking shall be affixed before radio equipment is placed on the market.  

The CE marking shall be followed by the identification number of the notified body 
where the conformity assessment procedure 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. 

2. 

3. 

4. 

5. 

6. 

The  technical  documentation  shall  contain  all  relevant  data  or  details  of  the  means 
used  by  the  manufacturer  to  ensure  that  radio  equipment  complies  with  the 
requirements  set  out  in  Article  3.  It  shall,  at  least,  contain  the  documents  listed  in 
Annex VI.  

The technical documentation shall be drawn up before radio equipment is placed on 
the market and shall be continuously updated. 

technical  documentation  and  correspondence  relating 

to  any  EU-type 
The 
examination  procedures  shall  be  drawn  up  in  an  official  language  of  the  Member 
State  in  which  the  notified  body  is  established  or  in  a  language  acceptable  to  that 
body.  

Technical  documentation  drawn  up 
the  corresponding 
specifications  of  the  national  standard  that  implements  the  relevant  harmonised 
standard  and/or  technical  specification  shall  be  presumed  to  provide  an  adequate 
basis for the assessment of conformity. 

in  accordance  with 

Following  a  reasoned  request  from  the  market  surveillance  authority  of  a  Member 
State,  the  manufacturer  shall  provide  a  translation  of  the  relevant  parts  of  the 
technical documentation into the language of that Member State.  

When  a  market  surveillance  authority  requests  the  technical  documentation  from  a 
manufacturer,  it  shall  be  transmitted  without  delay.  When  a  market  surveillance 
authority  requests  from  a  manufacturer  a  translation  of  technical  documentation  or 
parts thereof, it may fix a deadline for receipt of such translation, which shall be 30 
days, unless a shorter deadline is justified in the case of serious and immediate risk.  

Where the technical documentation does not comply with paragraphs 1, 2 or 3 of this 
Article,  and  in  so  doing  fails  to  present  sufficient  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 the manufacturer to have a test performed 

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by  a  body  acceptable  to  the  market  surveillance  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 the other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive.  

Article 23 

Notifying authorities 

1. 

2. 

3. 

4. 

1. 

2. 

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 bodies and the monitoring of notified bodies, 
including compliance with Article 28. 

Member  States  may  decide  that  the  assessment  and  monitoring  referred  to  in 
paragraph 1 shall be carried out by a national accreditation body within the meaning 
of and in accordance with Regulation (EC) No 765/2008. 

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 Article 24(1) to (6). In addition it shall 
have arrangements to cover liabilities arising out of its activities. 

The  notifying  authority  shall  take  full  responsibility  for  the  tasks  performed  by  the 
body referred to in paragraph 3. 

Article 24 

Requirements relating to notifying authorities 

A notifying authority shall be established in such a way that no conflict of interest 
with conformity assessment bodies occurs. 

A  notifying  authority  shall  be  organised  and  operated  so  as  to  safeguard  the 
objectivity and impartiality of its activities. 

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3. 

4. 

5. 

6. 

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. 

A  notifying  authority  shall  not  offer  or  provide  any  activities  that  conformity 
assessment bodies perform or consultancy services on a commercial or competitive 
basis. 

A notifying authority shall safeguard the confidentiality of the information it obtains. 

A  notifying  authority  shall  have  a  sufficient  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  procedures  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. 

2. 

3. 

4. 

For  the  purposes  of  notification,  a  conformity  assessment  body  shall  meet  the 
requirements laid down in paragraphs 2 to 11. 

A conformity assessment body shall be established under national law and have legal 
personality. 

A  conformity  assessment  body  shall  be  a  third-party  body  independent  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,  provision,  assembly,  use  or 
maintenance  of  radio  equipment  which  it  assesses,  may,  on  condition  that  its 
independence  and  the  absence  of  any  conflict  of  interest  are  demonstrated,  be 
considered such a body. 

A  conformity  assessment  body,  its  top  level  management  and  the  personnel 
responsible  for  carrying  out  the  conformity  assessment  tasks  shall  not  be  the 
designer,  manufacturer,  supplier,  installer,  purchaser,  owner,  user  or  maintainer  of 
the  radio  equipment  which  they  assess,  nor  the  authorised  representative  of  any  of 
those  parties.  This  shall  not  preclude  the  use  of  assessed  radio  equipment  that  is 
necessary  for  the  operations  of  the  conformity  assessment  body  or  the  use  of  such 
radio equipment for personal purposes. 

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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, manufacture or construction, the marketing, installation, use 
or  maintenance  of  that  radio  equipment,  or  represent  the  parties  engaged  in  those 
activities.  They  shall  not  engage  in  any  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 their subsidiaries or 
subcontractors  do  not  affect  the  confidentiality,  objectivity  or  impartiality  of  their 
conformity assessment activities. 

5. 

6. 

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  specific  field  and  shall  be  free  from  all 
pressures  and  inducements,  particularly  financial,  which  might  influence  their 
judgement  or  the  results  of  their  conformity  assessment  activities,  especially  as 
regards persons or groups of persons with an interest in the results of those activities. 

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 assessment 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 disposal 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 and the ability of reproduction of those 
procedures.  It  shall  have  appropriate  policies  and  procedures  in  place  that 
distinguish between tasks it carries out as a notified body and other activities; 

(c)  procedures for the performance of activities which take due account of the size 
of  an  undertaking,  the  sector  in  which  it  operates,  its  structure,  the  degree  of 
complexity  of  radio  equipment  technology  in  question  and  the  mass  or  serial 
nature of the production process. 

It  shall  have  the  means  necessary  to  perform  the  technical 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 covering all the conformity assessment 
activities  in  relation  to  which  the  conformity  assessment  body  has  been 
notified; 

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(b) 

(c) 

satisfactory  knowledge  of  the  requirements  of  the  assessments  they  carry  out 
and adequate authority to carry out those assessments; 

appropriate knowledge and understanding of the essential requirements set out 
in  Article  3,  of  the  applicable  harmonised  standards  and  of  the  relevant 
provisions of Union harmonisation legislation and of national legislation; 

(d) 

the  ability  to  draw  up  certificates,  records  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. 

9. 

10. 

11. 

The  remuneration  of  the  top  level  management  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. 

Conformity  assessment  bodies  shall  take  out  liability  insurance  unless  liability  is 
assumed by the State in accordance with national law, or the Member State itself is 
directly responsible for the conformity assessment. 

The  personnel  of  a  conformity  assessment  body  shall  observe  professional  secrecy 
with regard to all information obtained in carrying out their tasks under this Directive 
or  any  provision  of  national  law  giving  effect  to  it,  except  in  relation  to  the 
competent  authorities  of  the  Member  State  in  which  its  activities  are  carried  out. 
Proprietary rights shall be protected. 

Conformity  assessment  bodies  shall  participate  in,  or  ensure  that  their  assessment 
personnel  are  informed  of,  the  relevant  standardisation  activities,  the  regulatory 
activities in the area of radio equipment and frequency planning, and the activities of 
the  notified  body  coordination  group  established  under  the  relevant  Union 
harmonisation legislation and apply as general guidance the administrative decisions 
and documents produced as a result 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 far as the applicable harmonised standards cover 
those requirements. 

Article 28 

Subsidiaries of and subcontracting by notified bodies 

1. 

Where  a  notified  body  subcontracts  specific  tasks  connected  with  conformity 
assessment  or  has  recourse  to  a  subsidiary,  it  shall  ensure  that  the  subcontractor  or 

EN 

33 

   EN 

 
2. 

3. 

4. 

1. 

2. 

3. 

1. 

2. 

3. 

4. 

the  subsidiary  meets  the  requirements  set  out  in  Article  26  and  shall  inform  the 
notifying authority accordingly. 

Notified  bodies  shall 
the 
subcontractors or subsidiaries wherever these are established. 

take  full  responsibility  for 

tasks  performed  by 

Activities  may  be  subcontracted  or  carried  out  by  a  subsidiary  only  with  the 
agreement of the client. 

Notified  bodies  shall  keep  at  the  disposal  of  the  notifying  authority  the  relevant 
documents concerning the assessment of the qualifications of the subcontractor or the 
subsidiary and the work carried out by them under this Directive. 

Article 29 

Application for notification 

A  conformity  assessment  body  shall  submit  an  application  for  notification  to  the 
notifying authority of the Member State in which it is established. 

That application shall be accompanied by a description of the conformity assessment 
activities,  the  conformity  assessment  module  or  modules  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 accreditation body attesting that the 
conformity assessment body fulfils the requirements laid down in Article 26. 

Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate, it shall provide the notifying authority 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 

Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have 
satisfied the requirements laid down in Article 26. 

They shall notify the Commission and the other Member States using the electronic 
notification tool developed and managed by the Commission. 

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. 

Where  a  notification  is  not  based  on  an  accreditation  certificate  as  referred  to  in 
Article  29(2),  the  notifying  authority  shall  provide  the  Commission  and  the  other 
Member  States  with  documentary  evidence  which  attests  to  the  conformity 
assessment body's competence and the arrangements in place to ensure that that body 
will be monitored regularly and will continue to satisfy the requirements laid down in 
Article 26. 

EN 

34 

   EN 

 
5. 

The  body  concerned  may  perform  the  activities  of  a  notified  body  only  where  no 
objections  are  raised  by  the  Commission  or  the  other  Member  States  within  two 
weeks  of  a  notification  where  an  accreditation  certificate  is  used  or  within  two 
months of a notification where 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  States  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 identification 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 available the list of the bodies notified under 
this Directive, including the identification numbers 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. 

2. 

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 that it is failing to fulfil 
its obligations, the notifying authority shall restrict, suspend or withdraw notification 
as  appropriate,  depending  on  the  seriousness  of  the  failure  to  meet  those 
requirements or fulfil those obligations. It shall immediately inform the Commission 
and the other Member States accordingly. 

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 responsible 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 notified body or the continued fulfilment by 
a notified body of the requirements and responsibilities to which it is subject. 

EN 

35 

   EN 

 
2. 

3. 

4. 

1. 

2. 

3. 

4. 

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. 

The Commission shall ensure that all sensitive information obtained in the course of 
its investigations is treated confidentially. 

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  necessary  corrective  measures,  including  de-
notification if necessary. 

Article 34 

Operational obligations of notified bodies 

Notified  bodies  shall  carry  out  conformity  assessments  in  accordance  with  the 
conformity assessment procedures provided for in Annexes IV and V. 

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 structure, the degree of complexity of the product technology in 
question and the mass or serial nature of the production process. 

In  so  doing  they  shall  nevertheless  respect  the  degree  of  rigour  and  the  level  of 
protection required for the compliance of radio equipment with this Directive. 

Where  a  notified  body  finds  that  the  essential  requirements  set  out  in  Article  3  or 
corresponding harmonised standards or technical specifications have not been met by 
a  manufacturer,  it  shall  require  that  manufacturer  to  take  appropriate  corrective 
measures and shall not issue a conformity certificate. 

Where,  in  the  course  of  the  monitoring  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 certificate if necessary. 

Where  corrective  measures  are  not  taken  or  do  not  have  the  required  effect,  the 
notified body shall restrict, suspend or withdraw any certificates, as appropriate. 

Article 35 

Appeal against decisions of notified bodies 

Member States shall ensure that an appeal procedure against decisions of the notified bodies 
is available. 

EN 

36 

   EN 

 
Article 36 

Information obligation on notified bodies 

1. 

Notified bodies shall inform the notifying 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 have received from market surveillance 
authorities regarding conformity assessment activities; 

(d)  on  request,  conformity  assessment  activities  performed  within  the  scope  of 
their  notification  and  any  other  activity  performed,  including  cross-border 
activities and subcontracting. 

2. 

Notified bodies shall provide the other bodies notified under this Directive carrying 
out  similar  conformity  assessment  activities  covering  the  same  categories  of  radio 
equipment  with  relevant  information  on  issues relating  to  negative and, on request, 
positive conformity assessment results. 

3. 

Notified bodies shall fulfil information obligations under Annexes IV and V. 

Article 37 

Exchange of experience 

The  Commission  shall  provide  for  the  organisation  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 cooperation between bodies 
notified under this Directive are put in place and properly operated in the 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 

37 

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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.  

Procedure for dealing with radio equipment presenting a risk at national level 

Article 40 

1. 

2. 

3. 

Where  the  market  surveillance  authorities  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 equipment 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 requirements laid down in this Directive. The 
relevant  economic  operators  shall  cooperate  as  necessary  with  the  market 
surveillance authorities. 

Where, in the course of that evaluation, the market surveillance 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 equipment from the market, or to recall it within 
a reasonable period, commensurate with the nature of the risk, as they may prescribe. 

The  market  surveillance  authorities  shall  inform  the  relevant  notified  body 
accordingly. 

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in 
the second subparagraph. 

Where  the  market  surveillance  authorities  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  evaluation  and  of  the  actions  which  they  have 
required the economic operator to take. 

The economic operator shall ensure that all appropriate corrective action is taken in 
respect  of  all  radio  equipment  concerned  that  it  has  made  available  on  the  market 
throughout the Union. 

EN 

38 

   EN 

 
4. 

5. 

6. 

7. 

8. 

1. 

Where  the  relevant  economic  operator  does  not  take  adequate  corrective  action 
within the period referred to in the second subparagraph of paragraph 1, the market 
surveillance authorities shall take all appropriate provisional measures to prohibit or 
restrict radio equipment being made available on their national market, to withdraw 
radio equipment from that market or to recall it. 

The  market  surveillance  authorities  shall  inform  the  Commission  and  the  other 
Member States, without delay, of those measures. 

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 duration of the national measures taken and the 
arguments put forward by the relevant economic operator. In particular, the market 
surveillance  authorities  shall  indicate  whether  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  aspects  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. 

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 information at their disposal relating to the non-compliance of 
radio  equipment  concerned,  and,  in  the  event  of  disagreement  with  the  notified 
national measure, of their objections. 

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  State,  that  measure  shall  be  deemed 
justified. 

Member States shall ensure that appropriate restrictive measures are taken in respect 
of the apparatus concerned without delay. 

Article 41 

Union safeguard procedure 

Where, on completion of the procedure set out in Articles 40(3) and 40(4), objections 
are  raised  against  a  measure  taken  by  a  Member  State,  or  where  the  Commission 
considers  a  national  measure  to  be  contrary  to  Union  legislation,  the  Commission 
shall without delay enter into consultation with the Member States and the relevant 
economic operator or operators and shall evaluate the national measure. On the basis 
of  the  results  of  that  evaluation,  the  Commission  shall  decide  whether  the  national 
measure is justified or not. 

EN 

39 

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The  Commission  shall  address  its  decision  to  all  Member  States  and  shall 
immediately  communicate  it  to  them  and  the  relevant  economic  operator  or 
operators. 

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  unjustified,  the  Member  State  concerned  shall 
withdraw the measure. 

Where  the  national  measure  is  considered  justified  and  the  non-compliance  of  the 
radio equipment is attributed to shortcomings in the harmonised standards referred to 
in  Article  16  of  this  Directive,  the  Commission  shall  apply  the  procedure  provided 
for in Article [8] of Regulation (EU)No[../..] [on European Standardisation]. 

Article 42 

Compliant radio equipment which presents a risk to health and safety 

Where,  having  performed  an  evaluation  under  Article  40(1),  a  Member  State  finds 
that although radio equipment is in compliance with this Directive, it presents a risk 
to  the  health  or  safety  of  persons  or  to  other  aspects  of  public  interest  protection 
covered by this Directive it shall require the relevant economic 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, commensurate with the nature of the 
risk, as it may prescribe. 

The economic operator shall ensure that corrective action is taken in respect of all the 
radio equipment concerned.  

The Member State shall immediately inform the Commission and the other Member 
States.  That  information  shall  include  all  available  details,  in  particular  the  data 
necessary for the identification of the radio 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. 

The Commission shall without delay enter into consultation with the Member States 
and  the  relevant  economic  operator  or  operators  and  shall  evaluate  the  national 
measures taken. On the basis of the results of that evaluation, the Commission shall 
decide  whether  the  measure  is  justified  or  not,  and  where  necessary,  propose 
appropriate measures. 

The  Commission  shall  address  its  decision  to  all  Member  States  and  shall 
immediately  communicate  it  to  them  and  the  relevant  economic  operator  or 
operators. 

2. 

3. 

1. 

2. 

3. 

4. 

5. 

Article 43 

Formal non-compliance 

EN 

40 

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1. 

Without prejudice to Article 40, where a Member State makes one of the following 
findings,  it  shall  require  the  relevant  economic  operator  to  put  an  end  to  the  non-
compliance concerned: 

(a) 

the CE marking has been affixed in violation 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) 

(g) 

product  does  not  comply  with  the  requirements  set  out  in  Articles  10(5),  (6) 
and 12(3); 

information on intended use of radio equipment, 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  economic  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  appropriate  measures  to  restrict  or  prohibit  corresponding 
radio equipment being made available on the market 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. 

2. 

the  Telecommunication  Conformity 
The  Commission  shall  be  assisted  by 
Assessment  and  Market  Surveillance  Committee.  That  committee  shall  be  a 
committee within the meaning of Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  4  of  Regulation  (EU)  No 
182/2011 shall apply. 

EN 

41 

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Article 45 

Exercise of the delegation 

1. 

2. 

3. 

4. 

5. 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article.  

The  delegation  of  power  referred  to  in  Articles  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] 

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  Parliament  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.  

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

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 expressed 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 penalties 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 effective, proportionate and dissuasive.  

Member States shall notify those provisions to the Commission by [insert date – the date set 
out  in  the  second  subparagraph  of  Article  Transposition(1)]  at  the  latest  and  shall  notify  it 
without delay of any subsequent amendment affecting them. 

EN 

Article 47 

Review and reporting 

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1. 

2. 

Member States shall send the Commission regular reports on the application of this 
Directive  by  [date,  -  three  years  after  the  entry  into  force  of  this  Directive]  and  at 
least every two years thereafter. The report shall contain a presentation of the market 
surveillance activities performed by the Member 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. 

The  Commission  shall  review  the  operation  of  this  Directive  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  relevant  standards,  as  well  as  any  problems  that  have 
arisen in the course of implementation. The report shall also outline the activities of 
the  Committee,  assess  progress  in  achieving  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  equipment  should  be  developed  in 
order to achieve the following: 

(a) 

(b) 

ensure  that  a  coherent  system  is  achieved  at  Union  level  for  all  radio 
equipment; 

allow for convergence of the telecommunications, audiovisual and information 
technology sectors; 

(c) 

enable harmonisation of regulatory measures at international level. 

It  shall  in  particular  examine  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  available  on  the  market  and/or  putting  into 
service of radio equipment covered by Directive 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 [insert date - 18 months after adoption] at 
the  latest,  the  laws,  regulations  and  administrative  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  [day  after  the  date  set  out  in  the  first 
subparagraph]. 

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When  Member  States  adopt  those  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 twentieth 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.

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ANNEX I 

EQUIPMENT NOT COVERED BY THIS DIRECTIVE  

1. 

2. 

3. 

4. 

5. 

Radio  equipment  used  by  radio  amateurs  within  Article  1,  definition  56,  of  the 
the 
International  Telecommunications  Union  (ITU)  radio  regulations  unless 
equipment is available commercially. 

Kits  of  components  to  be  assembled  by  radio  amateurs  and  commercial  equipment 
modified  by  and  for  the  use  of  radio  amateurs  are  not  regarded  as  commercially 
available equipment. 

Marine equipment falling within the scope of Council Directive 96/98/EC36. 

Cabling and wiring. 

Test  equipment  exclusively  intended  for  the  testing  of  radio  equipment  by 
professional users. 

Aeronautical  products,  parts  and  appliances  within  the  meaning  of  Article  3  of 
Regulation (EC) No 216/2008 of the European Parliament and of the Council37. 

36 
37 

OJ L 46, 17.2.1997, p. 25 
OJ L 79, 19.3.2008, p. 1 

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ANNEX II 

PRODUCTS FALLING WITHIN THE DEFINITION OF RADIO EQUIPMENT 

For the purposes of this Directive the following products shall be deemed to be radio 
equipment: 

(a) 

active antennas; 

(b) 

jammers. 

For the purposes of this Directive the following products shall not be deemed to be 
radio equipment: 

1. 

2. 

(a)  passive antennas; 

(b) 

cochlear implants; 

(c)  microwave ovens. 

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ANNEX III 

CONFORMITY ASSESSMENT  

Module A (internal production control) 

1. 

Internal  production  control  is  the  conformity  assessment  procedure  whereby  the 
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and 
declares  on  his  sole  responsibility  that  radio  equipment  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 necessary so that the manufacturing process 
and its monitoring ensure compliance of the manufactured radio equipment with the 
technical  documentation  referred  to  in  point  2  and  with  the  relevant  essential 
requirements in Article 3. 

4. 

CE marking and declaration of conformity 

4.1. 

4.2. 

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. 

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 after 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  shall  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. 

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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 (Conformity to type based on internal production 
control) below. 

Module B 

EU-type examination 

1. 

EU-type  examination  is  the  part  of  a  conformity  assessment  procedure  in  which  a 
notified  body  examines  the  technical  design  of  radio  equipment  and  verifies  and 
attests  that  the  technical  design  of  radio  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  technical  design  of  radio  equipment  through 
examination  of  the  technical  documentation  and  supporting  evidence  referred  to  in 
point 3, without examination of a specimen (design type). 

3. 

The manufacturer shall lodge an application for EU-type examination with a single 
notified body of his choice. 

The application shall include: 

– 

– 

– 

– 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address as well, 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body, 

to  assess  radio  equipment's  conformity  with 

the  technical  documentation.  The  technical  documentation  shall  make  it 
the  applicable 
possible 
requirements  of  the  legislative  instrument  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  and  operation  of  radio  equipment.  The 
technical  documentation  shall  contain,  wherever  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  documents  that  have  been  used,  in 
particular  where 
technical 
specifications  have  not  been  applied  in  full.  The  supporting  evidence  shall 
include,  where  necessary,  the  results  of  tests  carried  out  by  the  appropriate 

relevant  harmonised  standards  and/or 

the 

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4. 

5. 

6. 

7. 

8. 

laboratory  of  the  manufacturer, or by another  testing laboratory on his behalf 
and under his responsibility. 

The  notified  body  shall  examine  the  technical  documentation  and  supporting 
evidence to assess the adequacy of the technical design of radio equipment; 

The  notified  body  shall  draw  up  an  evaluation  report  that  records  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 full or in part, only with the agreement of the manufacturer. 

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 conclusions 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  contain  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, giving detailed reasons for its refusal. 

The  notified  body  shall  keep  itself  apprised  of  any  changes  in  the  generally 
acknowledged state of the art which indicate that the approved type may no longer 
comply  with  the  applicable  requirements  of  the  legislative  instrument,  and  shall 
determine whether such changes require further investigation. If so, the notified body 
shall inform the manufacturer accordingly. 

The  manufacturer  shall  inform  the  notified  body  that  holds  the  technical 
documentation relating to the EU-type examination certificate of all modifications to 
the  assessed  type  that  may  affect  the  conformity  of  radio  equipment  with  the 
essential requirements  of the  legislative  instrument or the conditions  for validity of 
the certificate. Such modifications shall require additional approval in the form of an 
addition to the original EU-type examination certificate. 

Each  notified  body  shall  inform  its  notifying  authorities  concerning  the  EU-type 
examination  certificates  and/or  any  additions  thereto  which  it  has  issued  or 
withdrawn,  and  shall,  periodically  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  other  notified  bodies  concerning  the  EU-type 
examination  certificates  and/or  any  additions  thereto  which  it  has  refused, 
withdrawn,  suspended  or  otherwise  restricted,  and,  upon  request,  concerning  the 
certificates and/or additions thereto which it has issued. 

Each notified body shall inform Member States of EU-type examination certificates 
it has issued and/or additions thereto in those cases where harmonised standards, the 

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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 additions 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 notified body. The notified body shall 
keep a copy of the EU-type examination certificate, its annexes and additions, as well 
as the technical file including the documentation submitted by the manufacturer for a 
period of 10 years after radio equipment has been assessed or until the expiry of the 
validity of the certificate. 

The  manufacturer  shall  keep  a  copy  of  the  EU-type  examination  certificate,  its 
annexes  and  additions  together  with  the  technical  documentation  at  the  disposal  of 
the  national  authorities  for  10  years  after  radio  equipment  has  been  placed  on  the 
market. 

The manufacturer's authorised representative 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 

Conformity to type based on internal production control is the part of a conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 
points  2  and  3,  and  ensures  and  declares  that  radio  equipments  concerned  are  in 
conformity with the type described in the EU-type examination certificate and satisfy 
the requirements of the legislative instrument that apply to them. 

9. 

10. 

1. 

2. 

Manufacturing 

The manufacturer shall take all measures necessary 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 instrument that apply to them. 

3. 

CE marking and declaration of conformity 

3.1. 

3.2. 

The manufacturer shall affix the CE marking according to Articles 19 and 20 to each 
piece of radio equipment that is in conformity with the type described in the EU-type 
examination  certificate  and  satisfies  the  applicable  requirements  of  the  legislative 
instrument. 

The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  each  radio 
equipment  type  and  keep  it  at  the  disposal  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 equipment 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. 

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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  obligations  laid  down  in  points  2  and  5,  and 
ensures  and  declares  on  his  sole  responsibility  that  radio  equipment  concerned 
satisfies the requirements of the legislative instrument that apply to them. 

2. 

Manufacturing 

The manufacturer shall operate an approved quality system for design, manufacture 
and final product inspection and testing of radio equipment concerned as specified in 
point 3 and shall be subject to surveillance as specified in point 4. 

3. 

Quality system 

3.1. 

The  manufacturer  shall  lodge  an  application  for  assessment  of  his  quality  system 
with the notified body of his choice, for radio equipment concerned. 

The application shall include: 

– 

– 

– 

– 

the name and address of the manufacturer 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  technical  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  application  has  not  been  lodged  with  any 
other notified body. 

3.2. 

The  quality  system  shall  ensure  compliance  of  radio  equipment  with  the 
requirements of the legislative instrument that apply to them. 

All the elements, requirements and provisions adopted by the manufacturer shall be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  That  quality  system  documentation  shall  permit  a 
consistent interpretation of the quality programmes, plans, manuals and records. 

It shall, in particular, contain an adequate description of: 

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– 

– 

– 

– 

– 

– 

– 

the  quality  objectives  and  the  organisational  structure,  responsibilities  and 
powers of the management with regard to design and product quality, 

the  technical  design  specifications,  including  standards,  that  will  be  applied 
and,  where  the  relevant  harmonised  standards  and/or  technical  specifications 
will  not  be  applied  in  full,  the  means  that  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,  quality  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  achievement  of  the  required  design  and  product 
quality and the effective operation of the quality system. 

3.3. 

The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 3.2 of this Annex. 

It shall presume conformity with those requirements in respect of the elements of the 
quality  system  that  comply  with  the  corresponding  specifications  of  the  national 
standard  that  implements  the  relevant  harmonised  standard  and/or  technical 
specification. 

In  addition  to  experience  in  quality  management  systems,  the  auditing  team  shall 
have at least one member experienced as an assessor in the relevant radio equipment 
field  and  radio  equipment  technology  concerned,  and  knowledge  of  the  applicable 
requirements of the legislative instrument. The audit shall include an assessment visit 
to  the  manufacturer's  premises.  The  auditing  team  shall  review  the  technical 
documentation  referred  to  in  point  3.1,  second  indent,  to  verify  the  manufacturer's 
ability  to  identify  the  applicable  requirements  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 authorised representative shall be notified of the decision. 

The  notification  shall  contain  the  conclusions  of  the  audit  and  the  reasoned 
assessment decision. 

3.4. 

The  manufacturer  shall  undertake  to  fulfil  the  obligations arising  out  of  the  quality 
system as approved and to maintain it so that it remains adequate and efficient. 

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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  evaluate  any  proposed  changes  and  decide  whether  the 
modified quality system will continue to satisfy the requirements referred to in point 
3.2 or whether a reassessment is necessary. 

It  shall  notify  the  manufacturer  of  its  decision.  The  notification  shall  contain  the 
conclusions of the examination and the reasoned assessment decision. 

4. 

Surveillance under the responsibility of the notified body 

4.1. 

4.2. 

4.3. 

4.4. 

The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the 
obligations arising out of the approved quality system. 

The  manufacturer  shall,  for  assessment  purposes,  allow  the  notified  body  access  to 
the  design,  manufacture,  inspection,  testing  and  storage  sites,  and  shall  provide  it 
with all necessary information, in particular: 

– 

– 

– 

the quality system documentation, 

the  quality  records  as  provided  for  by  the  design  part  of  the  quality  system, 
such as results of analyses, calculations, tests, etc., 

the  quality  records  as  provided  for  by  the  manufacturing  part  of  the  quality 
system, such as inspection reports and test data, calibration data, qualification 
reports on the personnel concerned, etc. 

The notified body shall carry out periodic audits to make sure that the manufacturer 
maintains and applies the quality system and shall provide the manufacturer with an 
audit report. 

In addition, the notified body may pay unexpected 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 the proper functioning of the quality system. 
It  shall  provide  the  manufacturer  with  a  visit  report  and,  if  tests  have  been  carried 
out, with a test report. 

5. 

CE marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  CE  marking  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. 

The manufacturer shall draw up a written EU declaration of conformity for each type 
of radio equipment and keep it at the disposal 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 equipment 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. 

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6. 

The  manufacturer  shall,  for a period ending at least  10 years after radio equipment 
has been placed on the market, keep at the disposal of the national authorities: 

– 

– 

– 

– 

the technical documentation referred to in point 3.1, 

the documentation concerning the quality system referred to in point 3.1, 

the change referred to in point 3.5, as approved, 

the decisions and reports of the notified 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,  periodically  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 notified 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. 

.

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ANNEX VI 

Contents of Technical Documentation 

The  technical  documentation  shall,  wherever  applicable,  contain  at  least  the  following 
elements: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

a  general  description  of  the  radio  equipment  including:  photographs  or  illustrations 
showing  external  features,  marking  and  internal  layout;  versions  of  software  or 
firmware  affecting  compliance  with  essential  requirements;  user  information  and 
installation instructions; 

conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-
assemblies, circuits and other relevant similar elements; 

descriptions and explanations necessary for the understanding of those drawings and 
schemes and the operation of the radio equipment; 

a  list  of  the  harmonised  standards  and/or  other  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 descriptions 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  applied  harmonised  standards,  the  technical 
documentation shall specify the parts which have been applied; 

copy of the EU declaration of conformity; 

where the conformity assessment module in Annex IV has been applied, copy of the 
EU-type examination certificate and its annexes as delivered by the involved notified 
body; 

results  of  design  calculations  made,  examinations  carried  out,  and  other  relevant 
similar elements; 

(h) 

test reports. 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

ANNEX VII 

Declaration of Conformity 

No … (unique identification of the radio equipment): 

Name and address of the manufacturer or his authorised representative: 

This  declaration  of  conformity  is  issued  under  the  sole  responsibility  of  the 
manufacturer. 

Object of the declaration (identification of the radio equipment allowing traceability. 
It may include a photograph, where appropriate): 

The  object  of  the  declaration  described  above  is  in  conformity  with  the  relevant 
European Union harmonisation legislation: 

Radio Equipment Directive XXXX/xx 

Other European Union harmonisation legislation where applicable 

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 version and where applicable date of issue: 

Where applicable, the notified body ... (name, number) … performed … (description 
of intervention) … and issued the EU-type examination certificate: … 

Additional information: 

Where applicable, description of accessories and/or components, including software, 
which  allow  the  radio  equipment  to  operate  as  intended  and  covered  by  the 
Declaration of Conformity 

Signed for and on behalf of: ………………………………… 

(place and date of issue): 

(name, function) (signature): 

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ANNEX VIII 

Simplified Declaration of Conformity 

The simplified EU declaration of conformity referred to in the third subparagraph of Article 
10(8) shall be provided as follows:  

Hereby, [Name of manufacturer] declares that the radio equipment type [designation of type 
of radio equipment] is in compliance with Radio Equipment Directive XXXX/xx. 

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ANNEX IX 
Correlation table 

CORRELATION TABLE 

Directive 1999/5/EC  

This Directive 

Article 1 

Article 2 

Article 3 

Article 4(1) 

Article 4(2) 

Article 5 

Article 6(1) 

Article 6(2) 

Article 6(3) 

Article 6(4) 

Article 1 

Article 2 

Article 3, with the exception 
of Article 3(3)(g) 

Article 8 

Article 16 

Article 6 

deleted 

deleted 

Article 10(7), 10(8), 10(9) 

Article 7(1), 7(2) 

Article 7 

Article 7(3), 7(4), 7(5) 

deleted 

deleted 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 9 

Articles 39-43 

Article 17 

Articles 22-38 

Articles 19, 20, 10(5), 10(6) 

Articles 13 to 15 

Article 44 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Annex I 

deleted 

Article 47 

Article 48 

Article 49 

Article 50 

Article 51 

Article 52 

Annex I 

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Annex II 

Annex III 

Annex IV 

Annex V 

Annex VI 

deleted 

Annex III 

Annex IV 

Annex V 

Article 26 

Annex VII(1) to (4) 

Articles 19, 20 

Annex VII(5) 

New Articles 

Article 10(9) 

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 

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LEGISLATIVE FINANCIAL STATEMENT 

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1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

1.2. 

1.3. 

1.4. 

Title of the proposal/initiative: 

Policy area(s) concerned in the ABM/ABB structure 

Nature of the proposal/initiative: 

Objective(s):  

1.4.1.  The Commission's multiannual strategic objective(s) targeted by the proposal:  

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned 

1.5. 

1.6. 

1.7. 

Grounds for the proposal/initiative: 

Duration and financial impact: 

Management method(s) envisaged:  

2. 

MANAGEMENT MEASURES  

2.1. 

2.2. 

2.3. 

Monitoring and reporting rules  

Management and control system  

Measures to prevent fraud and irregularities 

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

Heading(s) of the multiannual financial framework and expenditure  budget 

line(s) affected:  

3.2. 

3.2.1. 

3.2.2. 

3.2.3. 

3.2.4. 

3.2.5. 

3.3. 

Estimated impact on expenditure  

Summary of estimated impact on expenditure  

Estimated impact on operational appropriations  

Estimated impact on appropriations of an administrative nature: 

Compatibility with the current multiannual financial framework 

Third-party participation in financing  

Estimated impact on revenue 

EN 

61 

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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  Directive  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  

(cid:133) The proposal/initiative relates to a new action  

(cid:133)  The  proposal/initiative  relates  to  a  new  action  following  a  pilot  project/preparatory 
action39  

X(cid:133) The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objectives 

1.4.1.  The Commission's multiannual strategic objective(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  market  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 
39 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

EN 

62 

   EN 

 
                                                 
The proposed legislative revision 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  the  avoidance  of  harmful  interference.  It 
should therefore improve protection of users and of fair competition, to bring increased 
legal  certainty,  smoother  and  more  consistent  application  of  the  Directive  and  more 
comprehensive  prevention  of  harmful  interference,  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  meeting  the  objectives  for  the  revision  of  the 
Directive are the following: 

Indicator 

Approach 

Compliance 

Administrative  and  technical 
compliance ratios 

Periodic 
Member States 

reports 

from 

Administrative 
simplification  and  legal 
adaptations 

Induced  administrative  cost 
and  burden,  number  and 
relative relevance of issues of 
interpretation 

Regular 
exchange  with 
stakeholders  —  economic 
operators, 
and 
notified bodies 

authorities 

Regulatory  barriers 
innovation 

to 

Perceived 
simplicity 
introducing innovations 

of 

Regular 
stakeholders 

exchange  with 

In accordance with the proposal, Member States would have a new obligation to send to 
the Commission biannual reports on the application of the Directive. 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  exchanges  within  TCAM,  the 
standing committee set up by the Directive, which in addition to Member States includes 
representatives  from  industry,  European  Standards  Organisations,  Notified  Bodies  and 
consumer organisations. The Commission plans to review the operation of this Directive 
and report thereon to the European 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  essential  requirements  for  the  protection  of 
health and safety and for the prevention of harmful interference. These requirements are 
translated into technical requirements 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;  Nevertheless,  experience  in  the  operation  of  the 

EN 

63 

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Directive has highlighted a number 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 application 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 keystone of the Single Market in this area. 
This  cannot  be  achieved  by  Member  States  acting  individually.  A  possible  new 
obligation to register at EU level manufacturers 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 similar experiences in the past 

Overall,  the  regulatory  framework  set  up  by  the  Directive  has  allowed  to  achieve  its 
intended  goals,  i.e.  a  high  level  of  protection  of  health  and  safety  for  users,  the 
electromagnetic  compatibility  (EMC)  for  telecommunication  terminals  and  radio 
equipment  as  well  as  the  avoidance  of  harmful  interference.  The  main  issues  to  be 
addressed  are  the  low  level  of  compliance  with  the  Directive  and  the  ambiguity  and 
complexity of some provisions in the Directive. 

1.5.4.  Coherence and possible synergy with other relevant instruments 

The proposed revision will be consistent with the principles of the Commission’s ‘Smart 
Regulation’  policy,  with  the  policy  for  Europe  2020,  in  particular  as  regards  the 
regulatory review foreseen within the policy for an Innovation Union , as well as with 
the proposed Radio Spectrum Policy Programme . 

The  initiative  will  also  be  consistent  with  the  New  Legislative  Framework  package 
approved  in  2008.  This  consists  of  two  complementary  instruments,  Regulation 
765/2008 on accreditation and market surveillance 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  that  products  on  their  market  are  safe  and  comply  with  the 
legal  requirements,  the  Decision  deals  with  the  relevant  obligations  imposed  on 
economic  operators  such  as  manufacturers,  importers  and  distributors,  as  well  as  the 
bodies  testing  and  certifying  products.  Hence,  the  two  instruments  are  inextricably 
linked  and  their  elements  mutually  support  and  complement  each  other.  Unlike  the 
Regulation, the Decision does 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 

64 

   EN 

 
                                                 
individuals or Member States, and provides (Article 2) that its provisions are to be used 
when legislation is drafted or revised. 

1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133)  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133)  Financial impact from YYYY to YYYY  

X(cid:133) 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(cid:133) Centralised direct management by the Commission  

(cid:133) Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133)  executive agencies  

–  (cid:133)  bodies set up by the Communities42  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

–  (cid:133)  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  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comments 

41 

42 

Details of management modes and references to the Financial Regulation may be found on the BudgWeb 
site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

EN 

65 

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2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

In accordance with the proposal, Member States would have a new obligation to send 
to the Commission biannual reports on the application of the Directive. 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 exchanges within TCAM, the 
standing  committee  set  up  by  the  Directive,  which  in  addition  to  Member  States 
includes  representatives  from  industry,  European  Standards  Organisations,  Notified 
Bodies and consumer organisations. The Commission plans to review the operation 
of  this  Directive  and  report  thereon  to  the  European  Parliament  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 placing 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 tendering 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 application of the Financial Regulation 

EN 

66 

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3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

•  Existing expenditure budget lines  

Heading of 
multiannual 
financial 
framework 

1a 
Competitiven
ess for 
growth and 
employment 

Budget line 

Type of  
expenditure

Contribution  

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  

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. 

Heading of 
multiannual 
financial 
framework 

Budget line 

Type of 
expenditure

Contribution  

Number  
[Heading……………………………………..] 

Diff./non-
diff. 

[XX.YY.YY.YY] 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  

YES/N
O 

YES/N
O 

YES/N
O 

YES/NO 

43 
44 
45 

Diff. = Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

67 

   EN 

 
 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

Number  1a. Competitiveness for growth and employment  

EUR million (to 3 decimal places) 

DG: ENTR 

(cid:121) Operational appropriations  

02.03.01,  

Commitments 

(1) 

Operation  and  development  of  the  internal 
fields  of 
market,  particularly 
notification, 
sectoral 
approximation. 

in 
certification 

and 

the 

Number of budget line 

of 

administrative 
Appropriations 
 from the envelope for specific programmes47  
Number of budget line 

an 

Payments 

Commitments 

Payments 

(2) 

(1a) 

(2a) 

nature 

financed 

TOTAL appropriations 

Commitments 

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 

0 

0 

0 

0 

0 

0 

0.3 

0.03 

0.03 

0.03 

0.3 

0.03 

0.03 

0.03 

Proposal of 
unlimited duration 

Proposal of 
unlimited duration 

(3) 

=1+1a 
+3 

0 

0 

0 

0.3 

0.03 

0.03 

0.03 

Proposal of 
unlimited duration 

46 
47 

EN 

Year N is the year in which implementation of the proposal/initiative starts. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, direct 
research. 

68 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
for DG ENTR 

(cid:121) TOTAL operational appropriations  

Payments 

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

=2+2a 

+3 

(4) 

(5) 

(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 

Commitments 

=4+ 6 

Payments 

=5+ 6 

0 

0 

0 

0 

0 

0 

0.3 

0.03 

0.03 

0.03 

0.3 

0.03 

0.03 

0.03 

Proposal of 
unlimited duration 

Proposal of 
unlimited duration 

If more than one heading is affected by the proposal / initiative: NO 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

Commitments 

=4+ 6 

Payments 

=5+ 6 

EN 

69 

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 

(cid:121) Human resources  

0.635 

0.635 

0.635 

0.635 

0.635 

0.635 

0.635 

(cid:121) Other administrative expenditure  

0.092 

0.092 

0.092 

0.092 

0.092 

0.092 

0.092 

TOTAL DG ENTR 

Appropriations  

0.727 

0.727 

0.727 

0.727 

0.727 

0.727 

0.727 

Proposal of 
unlimited duration 
Proposal of 
unlimited duration 
Proposal of 
unlimited duration 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

EN 

70 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

–  X(cid:133) 

The proposal/initiative requires the use of operational appropriations, as explained below: 

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 

Commitment appropriations in EUR million (to 3 decimal places) 

Indicate 
objectives and 
outputs  

(cid:216) 

Type 
of 
output
48 

Avera
ge 
cost  
of the 
output 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

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 

OUTPUTS 

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

Tota
l 
num
ber 
of 
outp
uts 

Total  
cost 

1 

0.3 

48 
49 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in Section 1.4.2. "Specific objective(s)…" 

EN 

71 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Maintenance of 
an IT database 
for product 
registration 

- Output 

Sub-total for specific objective N°1 

SPECIFIC OBJECTIVE No 2… 

- Output 

Sub-total for specific objective N°2 

TOTAL COST 

1 

0.03 

1 

0.03 

1 

0.03 

0.3 

0.03 

0.03 

0.03 

Proposal 
of 
unlimited 
duration 

Proposal 
of 
unlimited 
duration 

EN 

72 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  (cid:133)  The proposal/initiative does not require the use of administrative appropriations  

–  X(cid:133) 

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 

0.092 

0.092 

0.092 

0.092 

0.092 

0.092 

0.092 

0.727 

0.727 

0.727 

0.727 

0.727 

0.727 

0.727 

Other administrative 
expenditure  

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 551 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 5 
of the multiannual 
financial framework  

Proposal of 
unlimited 
duration 

Proposal of 
unlimited 
duration 

TOTAL 

0.727 

0.727 

0.727 

0.727 

0.727 

0.727 

0.727 

Proposal of 
unlimited 
duration

50 
51 

Year N is the year in which implementation of the proposal/initiative starts. 
Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former "BA" lines), indirect research, direct research. 

EN 

73 

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3.2.3.2.   Estimated requirements of human resources  

–  (cid:133)  The proposal/initiative does not require the use of human resources  

–  X(cid:133) 

The  proposal/initiative  requires  the  use  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) 

(cid:121) Establishment plan posts (officials and temporary agents) 

02 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

5 

5 

5 

5 

5 

5 

5 

(cid:121) 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) 

XX 01 04 yy 53 

- at Headquarters54 

- 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 redeployed within the DG, together if necessary with 
any additional allocation which may be granted to the managing DG under 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 Standing Committee, communication, coordination with DG 
Information Society on Spectrum Policy, assessment of Member States notifications of 

52 

53 
54 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young Experts 
in Delegations); LA= Local Agent; SNE= Seconded National Expert;  
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially for Structural Funds, European Agricultural Fund for Rural Development (EAFRD) and European 
Fisheries Fund (EFF). 

EN 

74 

   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 

75 

   EN 

 
 
3.2.4.  Compatibility with the current multiannual financial framework  

–  X(cid:133) 

Proposal/initiative 

financial 
framework:  all  measures  or  actions  included  in  this  Directive  are  consistent  and 
compatible  with  the  current  and  the  next  multiannual  financial  framework  (2014  to 
2020) as proposed by the Commission. 

the  current  multiannual 

is  compatible 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Explain  what  reprogramming  is  required,  specifying  the  budget  lines  concerned  and  the  corresponding 
amounts. 

–  (cid:133)  Proposal/initiative requires application of the flexibility 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 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 

Specify  the  co-financing 
body  

TOTAL appropriations 
cofinanced  

3.3. 

Estimated impact on revenue  

–  X(cid:133) 

Proposal/initiative has no financial impact on revenue. 

–  (cid:133)  Proposal/initiative has the following financial impact: 

• 

• 

(cid:133)  on own resources  

(cid:133)  on miscellaneous revenue  

Budget revenue line: 

Appropriation

Impact of the proposal/initiative56 

EUR million (to 3 decimal places) 

55 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

76 

   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 calculating 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. 

EN 

77 

   EN