COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Disclaimer: This report commits only the Commission's services involved in its preparatiion and does not prejudge the final form of any decision to be taken by the Commission. Accompanying the document Proposal for a Directive of the European Parliament and of the Council on the harmonisation of laws of the Member States to the making available on the market of radio equipment
Date: 2012-10-17
Institutions: European Commission
Subjects: Community certification, administrative formalities, electronic device, market supervision, marketing standard, quality standard, radio telecommunications, technical standard

EUROPEAN 
COMMISSION 

Brussels, 17.10.2012  
SWD(2012) 329 final 

COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT 
Disclaimer: This report commits only the Commission's services involved in its 
preparatiion and does not prejudge the final form of any decision to be taken by the 
Commission. 

Accompanying the document 

Proposal for a Directive of the European Parliament and of the Council on the 
harmonisation of laws of the Member States to the making available on the market of 
radio equipment 

{COM(2012) 584 final} 
{SWD(2012) 300 final} 

EN 

   EN 

 
 
 
 
  
 
TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

3. 

4. 

4.1. 

4.2. 

Introduction .................................................................................................................. 5 

Procedural issues and consultation of interested parties .............................................. 5 

Identification ................................................................................................................ 5 

Organisation and timing............................................................................................... 5 

Consultation and expertise ........................................................................................... 6 

Scrutiny by the Commission Impact Assessment Board ............................................. 7 

Context ......................................................................................................................... 7 

Problem definition........................................................................................................ 8 

Low level of compliance.............................................................................................. 8 

Problems related to the legal provisions of the Directive .......................................... 12 

4.2.1.  Ambiguity and complexity of the Directive............................................................... 12 

4.2.2.  Problems with the scope of the R&TTE Directive .................................................... 14 

4.3. 

4.4. 

4.5. 

4.6. 

Regulatory barriers to market entry of innovative radio equipment .......................... 15 

Other issues ................................................................................................................ 18 

Problem tree ............................................................................................................... 18 

Underlying drivers of the problem............................................................................. 19 

4.7.  Who is affected. ......................................................................................................... 20 

4.8. 

4.9. 

5. 

5.1. 

5.2. 

5.3. 

6. 

6.1. 

6.2. 

6.3. 

7. 

Foreseen evolution of the problem............................................................................. 20 

EU right to act ............................................................................................................ 21 

Objectives................................................................................................................... 21 

General objectives...................................................................................................... 21 

Specific and operational objectives............................................................................ 22 

Consistency with other policies and objectives ......................................................... 23 

Policy options............................................................................................................. 23 

Options addressing objective A ................................................................................. 23 

Options addressing objective B.................................................................................. 25 

Options addressing objective C.................................................................................. 26 

Analysis of impacts .................................................................................................... 27 

7.1. 

Identifying impacts..................................................................................................... 27 

EN 

2 

   EN 

 
7.2. 

Options addressing objective A: To achieve improved enforcement and compliance 
with the Directive....................................................................................................... 28 

7.2.1.  Effectiveness: ............................................................................................................. 28 

7.2.2. 

Impact on administrative costs................................................................................... 30 

7.2.3.  Direct costs of the options.......................................................................................... 32 

7.2.4. 

Impact on third countries: .......................................................................................... 32 

7.2.5.  Comparing the options addressing objective A. Preferred option ............................. 33 

7.3. 

Options addressing objective B: To make available a sound legal basis for the 
implementation of the essential requirements............................................................ 34 

7.3.1.  Effectiveness. ............................................................................................................. 34 

7.3.2. 

Impact on administrative and compliance cost .......................................................... 35 

7.3.3.  Comparing the options addressing objective B. Preferred option.............................. 37 

7.4. 

Options addressing objective C: to remove regulatory barriers to innovation in radio 
equipment................................................................................................................... 39 

7.4.1.  Effectiveness. ............................................................................................................. 39 

7.4.2.  Administrative and other costs................................................................................... 39 

7.4.3.  Comparing the options ............................................................................................... 40 

8. 

9. 

9.1. 

9.2. 

Preferred Options ....................................................................................................... 40 

Implementation, Monitoring and Evaluation ............................................................. 42 

Transposition and implementation............................................................................. 42 

Reporting and review ................................................................................................. 42 

ANNEX I. LIST OF ACRONYMS AND GLOSSARY.......................................................... 43 

ANNEX II. PRODUCT SCOPE OF THE R&TTE DIRECTIVE ........................................... 45 

ANNEX III. BASIC ECONOMIC DATA OF THE EU MARKET COVERED BY THE 
DIRECTIVE............................................................................................................................. 46 

ANNEX IV. SUMMARY OF THE 2007 PUBLIC CONSULTATION ................................. 49 

ANNEX V. LIST OF INTERVIEW PARTNERS FOR THE TECHNOPOLIS STUDY....... 51 

ANNEX VI. SUMMARY OF THE 2010 PUBLIC CONSULTATION ................................. 54 

EN 

3 

   EN 

 
ANNEX VII. ADDITIONAL ITEMS AFFECTING THE AMBIGUITY AND 
COMPLEXITY OF THE DIRECTIVE ................................................................................... 58 

ANNEX VIII. LEGISLATIION AFFECTING THE PUTTING INTO SERVICE OF RADIO 
EQUIPMENT........................................................................................................................... 59 

ANNEX IX. DETAILED DESCRIPTION OF OPTION A1 .................................................. 60 

ANNEX X. ESTIMATION OF THE DIRECT COST OF A PRODUCT REGISTRATION 
SYSTEM .................................................................................................................................. 61 

ANNEX XI. ESTIMATION OF ADDITIONAL COST POR SOME INDIVUAL 
PRODUCTS UNDER OPTION B2......................................................................................... 62 

ANNEX XII. ..............................................................................................................SME TEST
.................................................................................................................................................. 63 

ANNEX XIII. SELECTED REFERENCES ............................................................................ 64 

EN 

4 

   EN 

 
INTRODUCTION  

1. 
The object of this Impact Assessment report is a possible revision of the R&TTE1 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 
conformity2.  

The R&TTE Directive 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.  It  addresses  an  estimated  €63  billion  market  (2007 3),  covering  inter  alia  mobile 
phones, mobile network transmitters and fixed telephones4. The Directive entered into force 
in 1999, replacing a wealth of national type-approval schemes and other regulations, and has 
been essential to achieve an internal market in this area.  

The Second Progress Report on the operation of the R&TTE Directive, dated February 2010 
(see  reference  [2]5),  has  highlighted  a  number  of  emerging  problems  and  margins  for 
improvement to be addressed through legislative revision or other means.  

This Impact Assessment report analyses these problems, presents the policy options that are 
being  considered  to  address  them,  evaluates  their  impact  and  on  that  basis  proposes 
recommended measures. 

2. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  

2.1. 

Identification  

The lead Directorate-General for this impact assessment is DG Enterprise and Industry.  

Other  Directorate-Generals  involved  have  been  DG  Information  Society  and  Media,  DG 
Competition, DG Internal Market and Services, DG Health and Consumers, DG Justice, DG 
Mobility  and  Transport,  DG  Environment,  DG  Taxation  and  Customs  Union,  DG  Trade, 
Secretariat General. 
The proposal is included in the Commission Work Programme 20116. The reference of this 
proposal in Agenda Planning is 2009/ENTR/021 - Amendments to the R&TTE Directive. 

2.2. 

Organisation and timing 

The  Impact  Assessment  Steering  Group  (IASG)  met  three  times  in  order  to  discuss  the 
preparation of this impact assessment: 1st March 2010, 6th October 2010 and 28th April 2011. 

1 

2 
3 
4 

5 
6 

R&TTE= Radio and telecommunications terminal equipment. A list of acronyms used and a glossary 
can be found in Annex I 
Directive 1999/5/EC OJ L 91, 7.4.1999, p. 10–28 
Basic economic data of the EU market covered by the R&TTE Directive can be found in Annex III.  
Non-radio telecommunications infrastructure such as switching systems is excluded from the scope of 
the R&TTE Directive. More information about the product scope of the R&TTE Directive can be found 
in Annex II.  
A list of all references can be found in annex XIII.  
COM(2010)  623  final  VOL.  II  ANNEXES  to  the  COMMUNICATION  FROM  THE  COMMISSION 
Commission Work Programme 2011 

EN 

5 

   EN 

 
                                                 
2.3. 

Consultation and expertise 

Issues  raised  by  the  operation  of  the  Directive  and  possible  solutions  to  them  have  been 
discussed within TCAM7, the standing committee of the Directive, since its establishment in 
2000.  In  addition  to  Member  States  and  the  Commission,  TCAM  includes  representatives 
from  industry,  European  Standards  Organisations,  CEPT8,  notified  bodies  and  consumer 
organisations. 

A  first  public  consultation  took  place  in  2007,  where  60  respondents  answered  some  120 
questions  on  the  operation  of  the  Directive  (see  Annex  IV).  This  consultation  allowed  to 
identify the main problems in the operation of the Directive as well as the possible remedies. 
Issues identified through this consultation were included in the Second Progress Report on the 
operation of the R&TTE Directive (see ref. [2]). 

During  2009,  an  external  contractor  Technopolis  developed  for  the  Commission  a  study  on 
the  impact  of  different  options  addressing  the  need  to  improve  traceability  of  products  and 
their  compliance  with  the  requirements  in  the  Directive.  In  the  framework  of  the  study,  the 
consultant also carried out 49 interviews with different stakeholders, including SMEs (see ref. 
[8] and Annex V). 
During 2010,  three TCAM ad  hoc working groups9 were put in place in order to assess the 
impact of the different options pursuing the following objectives: 

(1) 

(2) 

To  improve  the  traceability  of  R&TTE  products  and  their  compliance  with  the 
provisions in the Directive. 

To  align  the  R&TTE  Directive  with  the  provisions  of  the  New  Legislative 
Framework  (NLF10)  in  order  to  achieve  its  intended  goals:  improved  coherence  of 
legal  texts  with  regard  to  market  surveillance  and  notification  of  conformity 
assessment bodies, clarification of obligations for economic operators, harmonisation 
of conformity assessment procedures, simplification of EU safeguard measures 

(3) 

To make the regulatory environment for placing on the market and putting into use 
radio equipment more receptive to innovative radio technologies 

All  three  ad  hoc  working  groups  included  the  participation  of  public  authorities  and  other 
interested  stakeholders,  namely  companies,  notified  bodies,  consumer  representatives  and 
standards organisations. 

The Commission conducted a further public consultation between 16.07.2010 and 15.09.2010 
focussing on the impact of some of the measures under consideration. The questions covered 
the  following  topics:  improved  compliance  with  the  Directive,  clarification  of  the  Directive 
and  reduction  of  administrative  obligations,  issues  of  scope  and  accessibility  of  R&TTE 
products for all kinds of users. An adapted consultation specifically sought the views of SMEs 

7 
8 
9 
10 

Telecommunications Conformity Assessment and Market Surveillance Committee 
European Conference of Postal and Telecommunications Administrations 
See reference of the three final reports in Annex XIII, references [9], [10] and [11] 
The NLF consists of 2 regulations and a decision:  
-Regulation  (EC)  No  764/2008  of  9  July  2008  laying  down  procedures  relating  to  the  application  of 
certain national technical rules to products lawfully marketed in another Member State  
-Regulation  (EC)  No  765/2008 9 July  2008  setting  out  the  requirements  for  accreditation  and  market 
surveillance relating to the marketing of products;  
-Decision No 768/2008/EC of 9 July 2008 on a common framework for the marketing of products  

EN 

6 

   EN 

 
                                                 
 
 
 
through  the  network  Enterprise  Europe11.  The  Commission  received  contributions  from  122 
respondents,  including  50  SMEs,  36  other  economic  operators,  national  authorities,  notified 
bodies, standardisation bodies and other respondents. (see Annex VI and ref. [12]).  

During four meetings of TCAM in 2010, the Commission has consulted the Committee on the 
considered approach to address the issues subject to review. 

There is a high level of consensus and support for aligning the Directive with the NLF and for 
clarifying  and  simplifying  the  Directive.  Opinions  are  more  divided  on  the  possible 
introduction  of  compulsory  registration,  on  some  measures  of  administrative  simplification 
such as the suppression of current article 6.4 (see 4.2.1 below), and on adaptations of scope 
such as those potentially affecting broadcast receivers (see 4.2.2 below). 

2.4. 

Scrutiny by the Commission Impact Assessment Board 

The  Impact  Assessment  Board  of  the  European  Commission  assessed  a  draft  version  of  the 
present  impact  assessment  report  and  issued  its  opinion  on  27th  June  2011.  The  Impact 
Assessment  Board  made  several  recommendations  and,  in  the  light  of  the  latter,  the  final 
impact assessment report: 

–  Clarifies the relation between compliance with the R&TTE Directive and a more efficient 
use of spectrum, taking into account other legislation at EU and national level affecting the 
use of radio equipment 

–  Makes  explicite  all  elements  underlying  Option  A4,  in  particular  the  procedure  for 

identification of categories of equipment to be subject to registration 

–  Indicates the positions of the main stakeholders with regard to the options considered 

–  Makes more explicite social impacts and impacts on consumers 

–  Clarifies how the proposed Options A1 to A4 facilitate and/or incentivise compliance by 

manufacturers based outside the EU 

3. 

CONTEXT 

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  in  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 
on RoHS12, WEEE13 and Batteries14, as well as implementing measures under the EcoDesign 
Directive15. 

11 
12 
13 
14 
15 

http://www.enterprise-europe-network.ec.europa.eu/index_en.htm 
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  

EN 

7 

   EN 

 
                                                 
With  regard  to  putting  into  service  of  radio  equipment,  the  legal  environment  is  more 
complex.  Radio  equipment  makes  use  of  spectrum,  the  management  of  which  is  largely  a 
national  competence.  Whereas  equipment  complying  with  the  R&TTE  Directive  can  in 
principle be used in the EU, national regulations, some of them harmonised at EU level, may 
introduce  further  restrictions  on  the  use  of  radio  equipment.  When  exercising  this 
competence, Member States shall comply with applicable EU legislation (see Annex VIII and 
section 4.5 below for a more detailed description).  

The Commission has issued two progress reports on the R&TTE Directive: 

–  A First  Progress Report, of 22.4.2004,  collecting  the experience of the first  five  years of 
operation of the Directive (see ref.[1]) and announcing the intention of the Commission to 
examine the need for revising the Directive and to make proposals 

The  Telecommunications,  Transport  and  Energy  Council  of  9-10  December  2004  adopted 
Conclusions on this first report and invited the Commission to examine the need for revising 
provisions of the R&TTE Directive and make the appropriate proposals 

–  A Second Progress Report, of 9.2.2010 (see ref.[2]) which, building on further experience 
on  the  operation  of  the  Directive  and  on  the  2007  public  consultation,  highlighted  a 
number  of  emerging  problems  and  margins  for  improvement  to  be  addressed  through 
legislative revision or other means 

4. 

PROBLEM DEFINITION  

4.1. 

Low level of compliance 

A low level of compliance with the requirements of the Directive has been observed, affecting 
both  the  essential  requirements  in  the  Directive  (the  protection  of  health  and  safety, 
electromagnetic  compatibility,  and  the  avoidance  of  harmful  interference)  and  the  related 
administrative requirements (e.g. CE marking, information on restrictions to use, Declaration 
of Conformity). The Second Progress Report (see ref.[2]) states: 

“a  very  low  level  of  compliance  to  the  provisions  of  the  Directive  was  observed 
among  low  power  radio  devices  and  to  a  lesser  extent  in  other  areas.  A  number  of 
importers  and  manufacturers  of  this  equipment  are  not  aware  of  the  Directive  or 
deliberately ignore it” 

This conclusion is based on evidence available from national Market Surveillance Authorities 
(MSAs) who cooperate within the administrative co-operation group ADCO-R&TTE16. Since 
the  Directive  entered  into  force,  ADCO-R&TTE  coordinated  four  EU-wide  market 
surveillance campaigns (see ref. [3], [4], [5] and [6]). 

The first campaign covered a broad range of products, subsequent campaigns focussed on a 
particular  category:  short-range  devices,  Private  Mobile  Radio  (PMR17)  and  2.4  GHz 

16 
17 

Administrative Cooperation in the R&TTE area 
PMR offers mobile radio communication to specific organisations such as the police, fire brigade and 
civil protection 

EN 

8 

   EN 

 
                                                 
devices18, and low-power FM19 transmitters. The table in next page summarises the results of 
the 4 campaigns: 

The  campaigns  have  found  values  ranging  between  28%  and  56%  for  compliance  with  the 
essential requirements, and even lower values for administrative compliance.  

The  most  recent  consolidated  report  available,  i.e.  the  2009  final  report  of  ADCO-R&TTE 
(see  ref.  [7])  also  shows  low  levels  of  compliance.  Of  6168  R&TTE  pieces  of  equipment 
inspected, 68 % were compliant with the essential requirements and only 56% were compliant 
with both essential and administrative requirements. 

Table 1. Summary of R&TTE market surveillance campaigns 

1st campaign 

2nd campaign 

3rd campaign 

4th campaign 

9/2002-10/2003 

1/2005-1/2006 

9/2008-5/2009 

6/2009-10/2009 

Product area  

Broad range of 
products 

Short-range devices 

PMR (Private 
Mobile Radio) and 
2.4GHz devices 

Low-power FM 
radio transmitters 

Sampled products 

Observed 
administrative 
compliance  

Observed 
compliance  with 
essential 
requirements 

Observed  overall 
compliance  

>1000 

24% 

180 

42% 

259 

40% 

60 

17% 

only 12% compliant 
including 
requirements on 
technical 
documentation  

only 15% compliant 
including 
requirements on 
technical 
documentation  

Not included in the 
campaign 

56% 

53%  

28% 

(60% for radio 
aspects) 

24% 

6% 

16% 

10% 

-22% for PMR 

-9% for 2.4 Ghz 
devices 

Other elements 

-Missing  DoC  and 
area of intended use 
particularly severe 

design 
-Missing 
schemes 
in 
technical  file  was  a 
major 
for 
non-compliance 

cause 

design 
-Missing 
schemes 
in 
technical  file  was  a 
major 
for 
non-compliance 

cause 

MSAs  have  found  that  for  a  non-negligible  part  of  equipment  non-complying  with  the 
essential  requirements,  no  evidence  was  available  of  a  conformity  assessment  having  taken 
place. Absence of a complete technical documentation has been a recurrent issue. Also basic 
requirements such as CE marking (15% absent/incorrect for equipment inspected in 2009) and 
a correct Declaration of Conformity (DoC) (33 % absent/incorrect for equipment inspected in 
2009) are often not complied with. In many cases the equipment concerned consists of low-
cost products for consumers, such as some toys with short-range radio features. However, the 
market  surveillance  campaigns  also  detected  low  levels  of  compliance  for  professional 
equipment such as PMR. 

18 

19 

2.4  GHz  devices  includes  WiFi  radio  local  access  Networks  (RLANs),  remote  control  equipment, 
Bluetooth communications equipment, etc 
Frequency Modulation 

EN 

9 

   EN 

 
 
 
 
                                                 
This  situation  affects  consumers,  law-abiding  manufacturers,  and  public  services.  The 
following consequences can be identified:  

(4) 

(5) 

Low  compliance  prevents  law-abiding  companies  from  competing  in  a  level-
playing field with companies that do not comply with the legal requirements of the 
Directive. Products not complying with the Directive and/or the conformity of which 
has  not  been  assessed  benefit  from  lower  costs  and  thereby  gain  competitive 
advantage over compliant products, thus distorting competition 

Low  compliance  exposes  citizens  to  possibly  unsafe  products,  thus  potentially 
entailing accidents and negative health impacts. In this respect, three aspects are to 
be considered: 

–  Electrical safety hazards arising from insufficient assessment of risks associated to 
the electrical characteristics of the equipment. As most R&TTE products used by 
consumers,  many  of  them  battery-powered,  are  of  relatively  low-risk,  direct 
consequences of non-compliance for human health and safety are usually limited 

–  Public exposure to electromagnetic fields (EMF) is a matter of concern. Primary 
responsibility  in  this  area  remains  with  Member  States.  At  EU  level  Council 
Recommendation  1999/519/EC20  includes  recommended  limits  for  the  exposure 
to  EMF  of  the  general  public.  Harmonised  standards  giving  presumption  of 
conformity with the essential requirements in the R&TTE Directive are designed 
to  ensure  that  the  public  is  not  exposed  beyond  the  limits  of  the  Council 
Recommendation. Compliance with the R&TTE Directive is important for public 
confidence  in  the  effective  surveillance  of  public  exposure  to  EMF  radiation, 
which in turn supports further deployment of radio technologies (e.g. base stations 
for mobile communications) 

–  Non-compliant  radio  equipment  may  create  harmful  interference  with  critical 
communication  services  such  as 
traffic 
management  or  public  safety.  Nuisances  on  such  critical  communications  may 
have fatal consequences or contribute to criminal activity, and several such cases 
have  been  reported  within  ADCO-R&TTE  (e.g.  long-range  walkie-talkies 
interfering with aeronautical communications) 

those  of  security  services,  air 

(6) 

Low  compliance  of  radio  equipment  with  the  Directive  also  prevents  a  more 
intensive and efficient use of radio spectrum, negatively affecting the potential for 
economic  growth  and  innovation  in  this  area21.  The  R&TTE  Directive  is  the  only 
legal instrument with requirements on the use of radio spectrum (e.g. power, width of 
frequency  band  used,  spurious  emissions)  to  be  complied  with  by  radio  equipment 
placed  on  the  EU  market.  Though  other  EU-level  and  national  regulations  (see 
Annex VIII) often set further requirements on the use of spectrum, ensuring that only 
equipment  complying  with  the  R&TTE  Directive  is  placed  on  the  market  is  very 
important for an effective and efficient use of spectrum: 

20 

21 

COUNCIL RECOMMENDATION of 12 July 1999 on the limitation of exposure of the general public 
to electromagnetic fields (0 Hz to 300 GHz) (1999/519/EC) 
COM/2010/0471  final  -  Proposal  for  a  DECISION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF 
THE COUNCIL establishing the first radio spectrum policy programme 

EN 

10 

   EN 

 
                                                 
-First, through the interaction between the R&TTE Directive and other EU/national 
regulations on the use of radio spectrum: where confidence in the enforcement of the 
Directive is poor, national authorities are reluctant to authorise more intense uses of 
radio spectrum in their regulations 

-Second,  influencing  the  behaviour  of  users  and  manufacturers:  equipment  non-
complying with the relevant R&TTE requirements creates harmful interference and 
dissuades users and manufacturers from using affected frequency bands; for example 
non-compliant walki-talkies interfering aeronautical communications oblige aviation 
authorities to reserve several frequency bands for these critical communications 

Different elements concur in explaining the low level of compliance observed: 

A)  The  current  text  of  the  R&TTE  Directive  is  considered  to  be  ambiguous  and 
unnecessarily complex (see Annex IV and ref. [2]). Section 4.2 below develops these aspects. 
A relatively high effort is required from manufacturers in order to understand their obligations 
under the Directive. 

B) Insufficient or inefficient enforcement by Market Surveillance Authorities: 

–  The relative low riskiness of the product area covered by the Directive, and the fact that 
phenomena  such  as  excessive  exposure  to  electromagnetic  fields  or  interference  among 
radio equipment are particularly difficult to ascertain, makes the detection by MSAs of the 
placing on the market of non-compliant products particularly difficult 

–  Market Surveillance is a national competence. MSAs monitor the market in order to detect 
and  withdraw  non-compliant  products.  Member  States  currently  commit  very  different 
amounts  of  resources  to  market  surveillance22.  Under  chapter  III  of  Regulation 
765/2008/EC23,  Member  States  shall  entrust  market  surveillance  authorities  with  the 
powers,  resources  and  knowledge  necessary  for  the  proper  performance  of  their  tasks. 
Tight budgetary conditions and the limited political visibility of MSAs have not allowed to 
fully implement this requirement up to this date, and no fundamental change is foreseeable 
in the near future. Lack of cooperation among MSAs also reduces the efficiency and the 
dissuasive  power  of  their  action.  This  point  is  being  addressed  as  well  under  NLF 
Regulation 765/2008/EC. 

–  Efficiency and effectiveness of MSAs is strongly hindered by the limited traceability of 
products and of manufacturers. Current provisions in the ‘Guide for the implementation of 
the Directive24’ include the obligation to provide the name and address of the manufacturer 
or his authorised representative in the DoC accompanying the product. Nevertheless, this 
non-legal obligation is not always followed, and often the data provided do not  allow an 
effective contact (see ref. [9] and [3] to [6]). When a valid contact point cannot be found, 
MSAs are obliged to unfurl the distribution chain in order to contact the person responsible 
for placing the product in the EU market. As an illustration, a market surveillance authority 
mentioned difficulties for contacting the responsible entity in 50% of the cases, entailing a 

22 

23 
24 

It needs to be pointed out that low compliance is also observed within Member States with relatively 
substantial resources available for market surveillance in the R&TTE area, e.g. Germany, France or The 
Netherlands 
See footnote 10 above 
http://ec.europa.eu/enterprise/sectors/rtte/documents/guidance/index_en.htm 

EN 

11 

   EN 

 
                                                 
time effort ranging between 0.25 and 0.75 manXdays. (see ref. [9]). Many MSAs devote 
large amounts of time and resources in order to trace products and the manufacturer or the 
importer  responsible  for  the  product  on  the  EU  market,  which  are  subtracted  from  the 
limited resources of MSAs. This can be also illustrated by the following statement given in 
an interview by another MSA: 

“When we find a product and suspect it to be non-compliant, we first try to contact the person 
responsible  for  the  market  introduction.  Frequently,  such  information  is  lacking,  e.g.  in  the 
packaging or on the product. We then ask the retailer where we found the product from whom 
he/she got the device. We continue with this contact provided to us and ask the supplier where 
he obtained the product from. The story can repeat itself for so long till we get to the very first 
importer of the product… this is extremely in-efficient and also in-effective” (see ref. [8]).  

Responsibilities  of  economic  operators  other  than  manufacturers,  i.e.  importers  and 
distributors  and  other  intermediators  such  as  web-platforms,  are  absent  in  the  current 
Directive.  This  creates  difficulties  in  obtaining  their  cooperation  in  the  enforcement  of  the 
Directive, cooperation which is particularly important when manufacturers are based outside 
the jurisdiction of the MSA. 

The  incentive  matrix  with  which  manufacturers  are  currently  confronted  is  characterised 
both by a high perceived cost of compliance, driven by the complexity of the Directive, and a 
low risk of sanctions in case of non-compliance, taking into account the limited resources and 
efficiency  of  enforcement.  Such  an  incentive  matrix  does  not  sufficiently  encourage 
manufacturers to comply with the legal requirements, especially those manufacturers with an 
ephemeral presence on the market. 

Table 2. Incentive matrix for compliance under the R&TTE Directive 

Barrier/Incentive 
compliance 

for 

Probability 
sanction25 
compliance 

of 

effective 
in  case  of  non 

Perceived 
cognitive  barrier 
to compliance 

High 

Low 

High 

Low 

X 

4.2. 

Problems related to the legal provisions of the Directive 

4.2.1.  Ambiguity and complexity of the Directive  

The  Directive  is  generally  considered  to  be  too  complex  and  ambiguous.  The  cases  below 
have  been  identified  within  the  2007  consultation  (see  Annex  IV  and  ref.  [2])  and  within 
TCAM26. 

There  are  different  interpretations  among  MSs  and  industry  on  whether  the  essential 
requirement in article 3.2 ('effective use of spectrum... so as to avoid harmful interference') is 
only  applicable  to  radio  equipment  when  transmitting  or  also  to  the  performance  of 
reception  by  radio  equipment.  The  community  of  standardisation  is  divided,  with 

25 

26 

Sanctions  depend  on  national  legislation  and  may  include  fines,  product  withdrawal  and  criminal 
sanctions 
Annex VII lists other elements in the Directive adding to its ambiguity and complexity 

EN 

12 

   EN 

 
 
 
 
                                                 
consequences  on  harmonised  standards  conferring  presumption  of  conformity  with  the 
requirement27.  This  ambiguity  also  affects  the  possibility  of  systematically  introducing 
harmonised standards setting requirements for all radio receivers in view of a more intensive 
and efficient use of radio spectrum.  

The 'alert sign' must be affixed on products where restrictions on their use are applicable in 
one  or  more  Member  States.  As  indicated  by  consumer  representatives  within  TCAM,  the 
practical  value  of  this  sign  for  consumers  is  very  limited.  There  have  been  extensive 
discussions  on  the  distinction  between  this  requirement  and  the  obligation  to  notify  to 
authorities the intention to place on the market equipment operating in non-harmonised bands, 
as  per  article  6.428.  Yet  the  distinction  remains  unclear  for  many  companies.  National 
authorities  use  these  notifications  in  very  different  ways.  While  some  consider  that  they 
facilitate  informing  manufacturers  on  possible  restrictions  on  use  of  the  equipment,  other 
authorities do not make any use of such notifications. They add to administrative burden for 
industry (43 % of respondents consider a suppression of this requirement to bring in some or 
significant reduction of burden, see ref. [12]). 

Member  States  have  different  interpretations  on  how  to  apply  the  requirements  in  the 
Directive  to  products  and  economic  operators  in  the  case  of  internet  sales  and  other 
distance sales, as shown by discussions within TCAM. For example, the applicability to web-
platforms based outside the EU of the concept of person responsible for placing on the market 
and ensuing obligations is unclear.  

The  ambiguities  and  redundancies  above  and  others  cited  in  Annex  VII  result  in  scarce 
resources of authorities and economic operators being consumed in interpretative discussions, 
lead to different approaches to the application of the Directive, and constitute a hindrance to 
the Internal Market.  

The Directive also includes many administrative provisions and experience has shown that 
there is scope for administrative simplification. This refers in particular to the obligation to 
affix  in  3  places,  namely  on  the  equipment,  on  the  package  and  on  user  instructions  the 
following elements, where applicable to a piece of equipment: 

(a) 

(b) 

(c) 

CE marking 

Notified Body number 

Alert sign 

These  obligations  create  burden  for  businesses  that  have  to  adapt  the  design  of  labelling, 
packaging and accompanying documentation for products, and also for public administrations 
in charge of monitoring them. 

Many R&TTE products are also covered with regard to other requirements by other pieces of 
EU  Harmonising  Legislation,  e.g.  for  Toys,  Machinery,  Lifts,  etc.  The  fact  that  many 
definitions,  obligations  and  procedures  are  similar  but  slightly  different  is  a  source  of 
difficulties and undue burden for economic operators.  

27 

28 

ETSI  TR  102  914  -  Aspects  and  implications  of  the  inclusion  of  receiver  parameters  within  ETSI 
standards 
See  for  instance  TCAM  (29)34  Proposed  approach  to  the  provision  of  information  on  equipment 
classes, restrictions to use and notifications 6_4 

EN 

13 

   EN 

 
                                                 
4.2.2.  Problems with the scope of the R&TTE Directive 

• 

Problems arising from the application of the Directive to certain equipment 

Within the scope of the Directive is currently included equipment for which the provisions 
of the Directive are not well adapted, in particular in the following cases: 

Software-defined radio (SDR) is a technology allowing to modify key operating parameters 
of  radio  equipment  (e.g.  frequency  range,  modulation,  output  power)  by  changing  its 
software. These parameters are central to compliance with all three essential requirements of 
the  R&TTE  Directive.  SDR  emerged  in  the  military  environment  and  has  until  now  had  a 
limited  impact  on  the  civil  market.  Most  SDR  products,  in  particular  for  base  stations  in 
mobile  networks,  remain  today  under  the  control  of  a  single  manufacturer.  However,  a 
foreseeable increased presence of SDR, in particular when independent software is uploaded 
on  equipment,  raises  questions  on  conformity  assessment  of  combinations  of  hardware  and 
software,  on  marking  and  information  requirements  for  products  and,  on  allocation  of 
responsibilities  for  non-compliance.  Lack  of  appropriate  provisions  in  the  Directive  creates 
legal uncertainty both for public authorities and for equipment manufacturers, and barriers 
to market uptake of these products. 

Complex installations, e.g. a high power TV broadcasting transmitter, are often continuously 
modified, and include pieces of equipment that are not placed on the market. However, as the 
Directive does not include any specific provision for them, installations and their components 
should be treated like normal products, which creates some legal and practical problems. For 
example the application of the obligation of both the complete installation and its components 
to comply with the essential requirements is problematic. One third of respondents to the 2007 
public  consultation  considered  that  installations  where  not  sufficiently  addressed  in  the 
Directive, while half of them considered this was not an issue. 

The effects of multiple pieces of individually compliant equipment may cumulate (e.g. in-
vehicle  radars  in  congested  traffic)  and  create  risk  to  health  or  harmful  interference.  The 
Directive does not easily allow to deal with risk arising from these situations. 
In the absence of voluntary industry agreements, lack of interoperability is an inconvenience 
for users and creates unnecessary waste of resources, as illustrated by the protracted inability 
of  the  market  to  generate  a  common  standard  for  chargers  for  mobile  telephones.  The 
Directive  already  allows  the  Commission  to  take  Decisions  requiring  certain  equipment 
classes  to  interoperate  with  emergency  services  and  with  network  interfaces,  but  not  with 
accessories. As shown by requests from the public and from the European Parliament, there is 
a  strong  societal  support  for  the  ongoing  Commission  initiative  to  harmonise  chargers  for 
mobile telephones29, and for extending such harmonisation to other equipment, e.g. laptops. 
The definition of ‘terminal’, a constitutive element of the scope of the Directive, depends on 
national decisions on the location of the Network Termination Point (NTP). A fixed terminal 
may be considered a 'terminal' for the purposes of the Directive in some Member States 
but  not  in  others:  equipment  such  as  an  ADSL  router  may  fall  within  the  scope  of  the 
R&TTE  D  in  a  Member  State  and  within  the  scope  of  EMCD30  and  LVD31  in  another  one. 
Although  the  applicable  essential  requirements  are  the  same  in  both  cases,  different 

29 

30 

31 

Memorandum  of  Understanding 
to  harmonise  chargers 
http://ec.europa.eu/enterprise/sectors/rtte/chargers/index_en.htm  
Electromagnetic  Compatibility  Directive,  2004/108/EC,  requires  electrical  equipment  to  comply  with 
an adequate level of electromagnetic compatibility. 
Low Voltage Directive, Directive 2006/95/EC, requires electrical equipment to be safe 

for  data-enabled  mobile  phones, 

EN 

14 

   EN 

 
                                                 
administrative requirements and legal basis create burden for manufacturers (e.g. Declaration 
of  Conformity  for  both  R&TTE  D  and  EMCD/LVD)  and  regulators,  and  prevent  a  more 
integrated  Internal  Market.  This  problem  was  highlighted  by  manufacturers  and  public 
authorities in the context of a related question within the 2010 consultation (see section 3 in 
ref. [12]) 

• 

Issues arising from products currently outside the scope of the Directive 

Receive-only radio equipment (e.g. GPS or Galileo receivers, receiver side of car-openers) 
is  generally  included  within  the  scope  of  the  Directive32.  Sound  and  TV  broadcasting 
receivers, the most important category of such receivers, are excluded from the Directive, and 
are  generally  covered  by  the  LVD  and  the  EMCD  or,  in  particular  in  the  case  of  battery 
powered equipment, by the GPSD33 and EMCD. The same equipment, if able to receive other 
data,  falls  within  the  scope  of  the  Directive.  Similar  equipment  is  therefore  subject  to 
different  legal  frameworks  and  essential  requirements,  creating  legal  uncertainty  and 
adding legal complexity to market surveillance.  

Also  outside  the  Directive  are  intentional  radiators  which  transmit  energy  through  radio 
waves  for  other  purposes  than  communication.  They  include  equipment  such  as  frequency 
jammers, wireless chargers, heating applications, sensors and other usually falling under the 
denomination  ISM  (industrial,  scientific  and  medical  applications).  Such  equipment  is  not 
covered by the R&TTE Directive but by the LVD and the EMCD, or, in the case of battery 
powered  equipment,  by  the  GPSD  and  EMCD.  If  able  to  communicate,  such  equipment  is 
however covered by the R&TTE Directive. Different equipment having the potential to create 
harmful interference is subject to different legal frameworks and essential requirements, 
adding  legal  complexity  to  market  surveillance  and  also  to  market  access  for  products  not 
clearly falling within legal definitions. 

4.3. 

Regulatory barriers to market entry of innovative radio equipment 

Market  access  for  new  radio  technologies  depends  on  the  possibility  for  manufacturers  to 
comply  with  the  R&TTE  Directive,  in  particular  through  the  availability  of  harmonised 
standards or of notified body opinions, but also on the availability of an appropriate allocation 
of spectrum and authorisation regime in the Member State where the equipment is intended 
for  use,  in  particular  where  frequency  bands  are  not  harmonised  by  implementing  measures 
under  the  Radio  Spectrum  Decision34.  As  identified  within  the  public  consultation  held  in 
2007,  a  number  of  issues  delay  or  discourage  market  entrance  for  innovative  radio 
technologies  in  the  EU  (see  ref.  [11]).  Within  the  scope  of  the  R&TTE  Directive  are  the 
following: 

• 

32 

33 

34 

35 

Conformity with the Essential Requirements in article 3.2 of the R&TTE Directive35 
is  usually  based  on  harmonised  standards  the  references  of  which  have  been 
published in the Official Journal of the European Union (OJEU). In past years, it has 
been  the  case  that  the  delay  for  publication  of  references  in  the  OJEU  has  been 
excessive, up to one year in some cases 

See  4.2  above  for  a  discussion  on  whether  essential  requirement  in  article  3.2  ('effective  use  of 
spectrum.. so as to avoid harmful interference') applies to receive-only radio equipment 
General  Product  Safety  Directive,  Directive  2001/95/EC,  requires  consumer  products  not  covered  by 
more specific legislation to be safe 
Decision  676/2002/EC  on  a  regulatory  framework  for  radio  spectrum  policy  in  the  European 
Community 
'effective use of spectrum… so as to avoid harmful interference’ 

EN 

15 

   EN 

 
                                                 
• 

Manufacturers  may  place  equipment  on  the  market  without  following  harmonised 
standards, provided that a positive opinion has been obtained from a notified body 
(NB). Difficulties in obtaining opinions from NBs have been reported in the absence 
of  technical  conditions  defined  for  the  use  of  spectrum  .  It  is  challenging  for  some 
notified  bodies  to  be  continuously  updated  on  deliberations  on  rules  for  the  use  of 
spectrum and on compatibility studies developed by CEPT (see ref [11]).  

Other issues fall mainly outside the scope of the R&TTE Directive: 

• 

• 

• 

• 

Lack of harmonisation of spectrum in the EU reduces economies of scale and makes 
national markets unattractive for innovators 

Excessive level of detail in the technical conditions for use of spectrum, as opposed 
to more flexible conditions allowing different technologies to share frequency bands 

A long and uncertain process for the re-allocation of spectrum when this is necessary 
for  innovative  use.  The  time  necessary  to  complete  the  process  depends  on  the 
complexity of the systems being considered and the presence of existing users of the 
bands  to  be  re-allocated.  Such  a  process  and  constellation  of  entities  is  in  contrast 
with  the  more  centralised  and  agile  decision  processes  of  trade  partners  and 
competitors such as US and Japan 

Lack  of  awareness  among  companies  and  SMEs  of  the  regulatory  decision-making 
processes for the placing on the market and the use of radio equipment 

These  issues  reflect  the  complex  processes  involving  the  several  entities  responsible  for 
different  regulatory  steps  for  the  placing  on  the  market  and  the  putting  into  service  of 
equipment using spectrum.  

Technical  conditions  for  use  of  spectrum  are  issued  by  Member  States  and  may  be 
harmonized either through binding EU Decisions pursuant to the Radio Spectrum Decision, or 
through  non-binding  CEPT  Decisions  or  Recommendations  (see  Annex  VIII  for  a  more 
detailed discussion). 

Relevant  authorisation  regimes  under  which  radio  equipment  will  operate  are  defined  at 
national  level  according  to  the  principles  of  the  Authorisation  Directive36,  which  covers 
Electronic Communications. 

The following figure presents a simplified view of the regulatory steps allowing the placing 
on the market and putting into service of radio equipment (see ref. [11]) where no harmonised 
standard is available and the frequency bands are not harmonised at EU level: 

Figure  1:  Simplified  diagram  for  the  preparation  of  harmonised  standards  and  regulatory 
decisions allowing the placing on the market and putting into service of radio equipment 

36 

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), OJ L 108, 
24.4.2002, p. 21–32  

EN 

16 

   EN 

 
                                                 
Manufacturer 

Notified body 

ETSI 

Harmoni
zed 
Standard

Equipment can 
now be marketed 
in the EU 

ETSI System 
Reference 
Document 

Equipment can now be 
marketed and used 
nationally and/or in the 
EU 

CEPT 

Report/ 
Recommendation/ 
Decision 

National 
and/or EU 
conditions of 
use through 
authorisation 
(s) 

Equipment can 
now be authorised 
for use nationally 
and/or in the EU 

EC 

The current repartition of responsibilities involves a number of entities both at European and 
at national levels. Progress in the decision-making process usually needs iterative exchanges 
among the different entities, with associated delays necessary to ensure transparency and due 
consultation of interested parties, in particular users of spectrum.  

Since 2007, the  EU has taken  a number of measures aimed at facilitating market access for 
innovative radio technologies. Such measures include: 

– 

– 

– 

the improvements in the second part of 2010 of the process for the publication 
of  references  of  harmonised  standards  in  the  Official  Journal  of  the  EU  has 
allowed to achieve a substantial reduction of delays  

the  review  of  the  Framework  Directive  in  200937  has  strengthened  the 
emphasis  on  flexibility  in  regard  to  the  use  of  spectrum  for  electronic 
communications services 

the  harmonisation  of  a  number  of  frequency bands introducing flexible usage 
conditions under the regime introduced by the Radio Spectrum Decision ( e.g. 
for Short Range Devices38) 

37 

38 

DIRECTIVE  2002/21/EC  of  7  March  2002  on  a  common  regulatory  framework  for  electronic 
communications networks and services 
Commission  Decision  2010/368/EU  amending  Decision  2006/771/EC  on  harmonisation  of  the  radio 
spectrum for use by short-range devices  

(Framework Directive) 

EN 

17 

   EN 

 
 
 
                                                 
– 

the  proposed  Radio  Spectrum  Policy  Programme39  provides  a  strategic 
framework  for  the  next  4-5  years  in  spectrum  management,  in  particular  in 
promoting innovation and encouraging efficient use of spectrum 

As a summary to this section, market entrance for innovative radio technologies in the EU has 
to cope with a relatively complex and slow-moving system. Where innovative technologies do 
not  fit  within  existing  harmonised  standards  and  regulatory  conditions  for  use  of  spectrum, 
legal uncertainty arises, and can deter potential investors and innovators. Some limited issues 
regarding  development/publication  of  harmonised  standards  and  information  of  notified 
bodies  on  regulatory  developments  can  be  tackled  within  the  framework  of  the  R&TTE 
Directive  and  are  addressed  by  the  objectives  and  policy  options  below,  but  the  most 
important issues arise in the area of spectrum regulation.  

4.4. 

Other issues 

Articles 3.1 and 3.2 contain the essential requirements at the core of the Directive. Article 3.3 
allows  the  Commission  to  take  Decisions  in  order  to  introduce  additional  essential 
requirements applying to categories of equipment to be defined. Since the entry into force of 
the Directive, the Commission has taken 5 decisions on the basis of article 3.3.e on access to 
emergency services. Article 3.3.f addresses support to ‘certain features in order to facilitate 
its  use  by  users  with  a  disability’.  Until  present,  this  article  has  not  been  the  subject  of  a 
Commission  Decision.  In  the  course  of  the  2010  public  consultation  (see  ref.  [12]), 
stakeholders were invited to discuss whether this provision needed to be amended in order to 
make  it  more  supportive  of  accessibility.  Most respondents agreed on the potential value of 
article  3.3.f,  while  some  called  upon  the  Commission  to  take  decisions  on  the  basis  of  this 
article,  and  others  preferred  to  focus  on  other  instruments  such  as  the  Universal  Service 
Directive40,  which  addresses  inter  alia  services  for  special  categories  of  population.  The 
conclusion  is  that  article  3.3.f  may  be  valuable  in  the  future  and  should  be  kept  as  it  is. 
Therefore, this aspect will not be discussed further under this impact assessment. 

4.5. 

Problem tree 

The  following  problem  tree  presents  a  stylised  view  of  the  causality  links  between  the 
problems  identified  within  the  operation  of  the  R&TTE  Directive  and  their  main 
consequences: 

Figure 2: Problem tree identified within the operation of the R&TTE Directive  

39 

40 

COM/2010/0471  final  -  Proposal  for  a  DECISION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF 
THE COUNCIL establishing the first radio spectrum policy programme 
DIRECTIVE 2002/22/EC of 7 March 2002 on universal service and users' rights relating to electronic 
communications networks and services (Universal Service Directive) 

EN 

18 

   EN 

 
                                                 
Insufficient cooperation 
among MSAs, 
insufficient resources 
allocated to some 
MSAs 

Ambiguity and 
complexity of the 
Directive 

Issues of scope, legal 
provisions not adapted 
to some products 

Complexity of the 
legal/institutional 
regulatory framework 
for placing on the 
market and use of radio 
equipment 

Insufficiently 
dissuasive enforcement 
by MSAs 

Difficulty/ineffic
iency in he 
application of 
the Directive by 
MSAs and 
manufacturers

Legal uncertainty/ 
complexity in 
conjunction with other 
Internal Market 
legislation 

Public exposure 
to unsafe 
products, risk of 
malfunction of 
equipment 

Distortion of 
competion 

Unnecessary cost 
and 
administrative 
burden

Inefficient use of 
spectrum 

Unrealised 
potential for 
innovation and 
first mover 
advantages in the 
EU 

Low compliance 

Delayed/discouraged 
innovation in radio 
equipment 

4.6. 

Underlying drivers of the problem 

As  noted  above  key  drivers  of  the  problems  of  non-compliance  and  complexity  are  the 
following: 

(7) 

(8) 

(9) 

(10) 

insufficient  resources  of  MSAs,  and  inefficiencies  in  their  use  due  to  inappropriate 
legal instruments for enforcement and lack of operational cooperation among MSAs 

a diversity of interpretations by economic operators and Member States of the scope 
and requirements laid down in the Directive  

economic operators face an incentive matrix for compliance with the Directive which 
combines a relatively high complexity with a low probability of sanctions 

increasing  proportion  of  manufacturers  non  located  in  the  EU,  in  particular  in  East 
Asia, who have more difficulties in understanding  the EU legal framework  and the 
Directive 

For the other problems, the drivers are: 

(11) 

technological  change  driving  the  appearance  of  software-defined  radio  and  the 
growing presence or radio components in many different products raising the issue of 
cumulative effects of technology 

(12) 

different  regulatory  approaches  raising  the  issue  of  specialised  equipment  falling 
within the R&TTE scope and other legislations 

EN 

19 

   EN 

 
 
 
(13) 

a multiplicity of entities regulating the use of spectrum at EU and at national level, 
and an only partial harmonisation of spectrum; the revision of the R&TTE Directive 
only offers limited opportunity to address this issue 

4.7.  Who is affected. 

As already mentioned in sections 4.1 to 4.6, several categories of stakeholders are affected by 
the current framework put in place by the R&TTE Directive and its implementation:  

(14) 

Users of R&TTE equipment, public services and citizens in general are exposed to 
an important share of non-compliant equipment. 

(15)  Manufacturers  are  affected  by  distortion  of  competition,  by  the  complexity  and 
ambiguity  of  the  Directive,  by  issues  of  scope  and  by  difficulties  in  bringing 
innovations to the market  

(16)  Market Surveillance Authorities are affected by difficulties in efficiently enforcing 

the Directive, in dealing with its complexity and ambiguity and with issues of scope 

4.8. 

Foreseen evolution of the problem 

NLF  Regulation  765/2008,  which  became  applicable  on  1  January  2010,  should  lead  to  a 
certain improvement of the current situation. It strengthens the obligations of Member States 
on market surveillance and provides for reinforced cooperation and information exchange on 
non  compliant  products.  It  also  requires  controls  of  imported  products.  Market  surveillance 
should  hence  become  more  effective  and  more  visible  and  deter  those  operators  who  have 
been encouraged by a perceived absence of market surveillance activities to take advantage of 
the system. However, even under the best functioning market surveillance system, authorities 
can only control a relatively limited amount of products on the market. Certain operators will 
still  try  their  luck,  in  particular  as  long  as  the  consequences  of  “being  caught”  (fines, 
withdrawal, effect on reputation, etc) are relatively minor in relation to the economic savings 
they can achieve.  

While the NLF Regulation might lead to a certain improvement of the current situation, at the 
same  time  certain  trends  suggest  a  worsening  of  the  problem.  Whereas  when  the  Directive 
entered  into  force  in  1999  a  significant  part  of  the  products  covered  were  manufactured  in 
Europe,  most  products  today  (80%,  see  Annex  III)  are  imported  from  trading  blocks 
where  awareness  of  EU  legal  requirements  is  limited,  and  this  trend  seems  to  be  sustained. 
Increased  delocalisation  of  production  will  also  make  the  tasks  of  market  surveillance 
authorities more complex and difficult. In many instances they will not be able to identify or 
directly  contact  the  manufacturer.  Consequently  they  will  need  to  rely  increasingly  on  the 
information provided by importers and distributors. The lack of traceability in the supply and 
distribution chain will then become an even bigger problem. With no action, compliance with 
the Directive should remain low. 

The presence of wireless communication devices has been significantly increasing in the 
last ten years. An increasing amount of other products such as machinery, vehicles and toys 
incorporate  radio  modules.  In  all  probability  this  trend  will  not  change.  No  action  would 
increasingly  allow  for  situations  of  risk  to  good  operation  of  devices  and  prevent  a  more 
efficient use of radio spectrum. 

EN 

20 

   EN 

 
Technological progress and market developments continously present new challenges  to the 
application of the Directive. The ‘Guide for the implementation of the Directive’ agreed by 
Member States and the Commission is a common reference for consistent application of the 
Directive, and maybe regularly updated. However, as it is not legally binding, Member States 
follow  it  to  different  degrees.  In  particular  increasing  amounts  of  equipment  modified  by 
software  are  expected  to  be  placed  on  the  EU  market,  lack  of  adequate  provisions  would 
render the application of the Directive difficult or impossible in this case.  

Further harmonisation of spectrum under the Radio Spectrum Decision and the impulse of 
the  Radio  Spectrum  Policy  Programme  should  simplify  regulatory  conditions  for  market 
access  of  radio  equipment  in  general,  enhance  the  flexibility  and  technology  neutrality  of 
spectrum  allocation,  and  provide  more  opportunities  for  license-free  access  to  spectrum  by 
innovative  products  in  particular.  The  Commission  plans  to  issue  a  Communication  on 
collective and shared use of spectrum. 

Continuous  efforts  by the  European  Standards Organisations and the Commission  to  reduce 
delays in development and publication of harmonised standards, and to develop technology-
neutral harmonised  standards  are  expected to facilitate their timely correspondence with the 
state of the art and thus enable market access for innovative products. 

4.9. 

EU right to act 

The Single Market is an area of ‘shared competence’ according to article 4 of the Treaty on 
the Functioning of the European Union (TFEU). The current R&TTE Directive, as one of the 
‘New Approach’ directives setting EU-wide harmonised requirements, has been instrumental 
in the completion of the internal market for radio and telecommunication terminal equipment. 
The objective of creating an open competitive single market for telecommunications and radio 
equipment  could  not  sufficiently  be  achieved  by  the  Member  States  acting  individually,  as 
different national requirements for the placing on the market of equipment fragment the EU 
market. 

The  revised  Directive  shall  be  based  on  TFEU  articles  26  (Internal  Market)  and  114 
(Approximation  of  Laws).  Action  at  EU  level  is  necessary  on  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 manufacturer and/or equipment as part of options addressing objective A would enable 
access  to  the  EU  market,  and  its  advantages  with  respect  to  multiple  similar  measures  at 
national level are clear. The changes of scope considered within options addressing objective 
B are limited, and affect other EU legislation rather than national competences. Some of the 
options considered for a revision of the regulatory environment of radio equipment (Objective 
C) affect spectrum regulation, an area largely within the competence of Member States, and 
this is addressed in section 7.4. The other options considered propose simplification or limited 
adaptation of the current Directive to some technologies, and therefore the EU right to act and 
the value-added of action at EU level can be considered uncontroversial for them.  

5. 

OBJECTIVES  

5.1. 

General objectives 

As  a  general  objective,  the  review  of  the  R&TTE  Directive  aims  to  ensure  better 
implementation  of  the  essential  requirements  in  the  Directive,  i.e.  to  ensure  a  high  level  of 

EN 

21 

   EN 

 
protection of health and safety for users and any other person, to ensure the electromagnetic 
compatibility of equipment, and to ensure an effective use of spectrum so as to avoid harmful 
interference. This must be achieved in a way that preserves free circulation of these products 
in the EU, does not create unnecessary costs and burden, in particular for SMEs, and supports 
innovation.  

5.2. 

Specific and operational objectives 

Specific  and  operational  objectives  in  line  with  the  problems  identified  in  section  4  are  the 
following: 

A 

To achieve improved enforcement and compliance with the Directive: 

• 

• 

To  reinforce  the  obligations  of  economic  operators,  and  to  improve  the  legal 
tools available to MSAs in order to improve their efficiency and effectiveness, 
in particular regarding traceability of products  

To simplify and clarify the requirements in the Directive in order to facilitate 
compliance by economic operators. This is also part of objective B 

To  make  available  a  sound  legal  basis  for  the  implementation  of  the  essential 

B 
requirements: 

• 

• 

• 

To clarify and simplify a number of provisions for economic operators, notified 
bodies  and  market  surveillance  authorities.  To  improve  the  coherence  of 
definitions  and  requirements  with  other  Internal  Market  legislation  and  with 
other  related  legislation  such  as  the  Radio  Spectrum  Decision  and  the 
regulatory framework for electronic communications. To modify or suppress a 
number  of  administrative  obligations  which  create  burden  but  bring  in  only 
limited value-added 

To facilitate the application of the Directive to equipment within the scope of 
the Directive which because of its nature, technology or patterns of use creates 
difficulties  in  the  operation  of  the  Directive,  i.e.  software  defined  radio, 
complex  installations,  equipment  prone  to  generate  cumulative  effects;  to 
enable harmonisation of interfaces between equipment and accessories 

To  rationalise  the  scope  of  the  Directive  so  that  it  includes  all  equipment  for 
which  avoidance  of  harmful  interference  (the  essential  requirement  in  article 
3.2) is relevant  

To  remove  regulatory  barriers  for  the  access  to  the  market  of  innovative  radio 

C 
equipment: 

• 

To  simplify  regulatory  decision-making  processes  and  to  reduce  associated 
delays conditioning market access of new technologies 

EN 

22 

   EN 

 
5.3. 

Consistency with other policies and objectives 

The  initiative  will  be  consistent  with  the  principles  of  the  ‘Smart  Regulation’  policy  of  the 
Commission41,  with  the  policy  for  Europe  2020,  in  particular  with  the  regulatory  review 
foreseen  within  the  policy  for  an  Innovation  Union42,  as  well  as  with  the  proposed  Radio 
Spectrum Policy Programme43. 

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

6. 

POLICY OPTIONS  

6.1. 

Options addressing objective A 

-Option A0 is the status quo.  

-Option  A1  is  an  alignment  with  the  New  Legislative  Framework  (NLF)  for  the 
marketing of goods. Alignment of Single Market harmonising legislation with the NLF is a 
commitment of the EU Council, Parliament and the Commission. One of the main objectives 
of the NLF is to improve compliance with legal requirements in the Internal Market, and in 
particular  to  strengthen  market  surveillance.  Alignment  with  the  NLF  would  include  the 
following elements from NLF Decision 768/2008/EC44: 

– 

– 

– 
– 

obligations  for  manufacturers,  importers  and  distributors  to  check  at  the 
different  steps  in  the  supply  chain  that  compliance  of  equipment  has  been 
assessed 
traceability  obligations  for  manufacturers,  importers  and  distributors:  to  mark 
their identity on the equipment, to keep a register of from whom they buy, to 
whom they sell (with the exception of consumers) at the different steps in the 
supply chain 
easier to use and more effective safeguard clauses 
penalties for administrative non-compliance  

This option also includes the improvement of cooperation with MSAs in countries exporting 
to  the  EU  so  that  they  contribute  to  raise  awareness  of  EU  regulatory  requirements  among 
those  manufacturers  within  their  jurisdiction.  This  cooperation  will  be  sought  within 

41 
42 

43 
44 

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 
See footnote 10 above 
A more detailed description of these elements can be found in annex IX. 

EN 

23 

   EN 

 
                                                 
regulatory dialogues between the Commission and third countries, as it has been the case in 
the area of toys. 

-Option  A2  includes  Option  A1  plus  the  obligation  for  manufacturers  to  register.  The 
manufacturer shall register in an ad hoc EU central registration system his contact data, and 
keep  them  updated.  The  system  returns  a  unique  company  registration  number,  which  the 
manufacturer shall affix on all products placed on the EU market.  

-Option A3 includes Option A1 plus the obligation to register individual product types. 
The manufacturer shall register in an ad hoc central EU registration system each new product 
type,  and  upload  part  of  the  technical  file.  The  system  returns  a  number  specific  to  each 
product  type,  which  the  manufacturer  shall  affix  on  each  corresponding  product.  Product 
registration intends a quick identification of products and online retrieval of the technical file 
by MSAs. This obligation could be applied as follows: 

– 

– 

– 

– 

The manufacturer registers, and is allocated a unique manufacturer identifier (mID)  

The manufacturer assigns a unique product identifier (pID) to each product type. This 
may be performed well in advance of placing a product on the market, so that details 
of both mID and pID are available when product design takes place  

The  manufacturer  assesses  the  conformity  of  the  product,  and  affixes  the  product 
identifier (mID+pID) to his product 

The manufacturer uploads in a central registration system a subset of the technical file 
of the product which has to be put together as part of conformity assessment 

-Option A4 includes Option A1 plus the possibility for the Commission, through the use 
of  delegated  powers  conferred  on  the  basis  of  article  290  TFEU,  to  introduce  product 
registration for some specific categories of equipment, where following the entry into force 
of the revised Directive a high level of compliance has not been achieved in those categories.  

– 

– 

– 

The Commission, following consultation with Member States and interested parties, 
would  decide  on  a  regular  basis  whether  and  for  which  product  categories 
registration  would  become  mandatory  or  would  cease  to  become  mandatory. 
Categories of products to be considered for product registration would be identified 
on  the  basis  of  evidence  provided  by  MSAs,  and  taking  into  account  other 
circumstances  such  as  particular  market/technology  situations  and  availability  of 
alternative  enforcement  measures.  Depending  on  the  situation  of  the  categories  of 
equipment  covered  by  the  delegated  act,  this  may  be  accompanied  by  a  specific 
impact assessment 

All manufacturers producing equipment within those categories would be required to 
register  relevant  products  as  long  as  the  measure  is  in  force.  Exceptions  could  be 
considered  for 
the  most  comprehensive 
conformity  assessment  module,  i.e.  Full  Quality  Assurance  module  according  to 
Annex V of the Directive 

those  manufacturers 

implementing 

The Commission would be in charge of implementing and operating the central EU 
registration system 

A clear majority of industry representatives have favoured option A1, and strongly opposed 
options  including  product  registration  (options  A3  or  A4),  alledging  that  it  would  bring 
significant additional burden upon law-abiding manufacturers but could still be circumvented 

EN 

24 

   EN 

 
by  other  manufacturers  .  Consumer  representatives  support  option  A3.  Market  surveillance 
authorities are equally split among those who value the increased efficiency and effectiveness 
of enforcement under option A3, and those who consider it unnecessary burden (see section 
7.2 for more detail, as well as Annex VI and refs. [9] and [12]) 

6.2. 

Options addressing objective B 

-Option  B0  is  the  status  quo  including  the  regular  update  of  the  ‘Guide  for  the 
implementation of the Directive’ 

-Option B1 includes: 

– 

– 

– 

– 

alignment  of  definitions,  obligations  and  conformity  assessment  procedures 
with the NLF for the Internal Market for goods45 

the  clarification  of  currently  problematic  provisions  on  the  basis  of  the 
current  ‘Guide  for  the  implementation  of  the  Directive’;  inclusion  of 
obligations of internet-based economic operators 

simplification  of  administrative  obligations  including  the  ‘Alert  Sign’ 
informing  users  of  restrictions  to  use,  and  the  suppression  of  a  number  of 
administrative obligations (see section 4.2) including notifications as per article 
6.4  

the improvement of consistency with the Regulatory Framework for Electronic 
Communications  and  the  Radio  Spectrum  Decision.  This  includes  the 
alignment  of  definitions  in  the  area  of  electronic  communications  and  the 
introduction of explicit references in the Directive to other EU requirements for 
use of radio equipment 

Suppression of notification to Member States of the placing on the market of equipment using 
non-harmonised  bands,  as  currently  provided  for  by  article  6.4,  is  compensated  with  an 
enhancement  of  existing  non-legislative  measures  providing  information  to  stakeholders  on 
regulation on the use of spectrum at EU and national level, namely the R&TTE sub-classes46 
under article 4.1 and the EFIS database47. 

-Option B2 includes option B1, plus the introduction of additional provisions to deal with 
some specific technologies and to address interoperability with accessories, and an extension 
of scope so that it includes all radio transmitters, radio receivers, and fixed terminals: 

– 

– 

introduce  specific  provisions  for  complex  installations,  for  software  defined 
radio equipment, and for equipment likely to create cumulative effects; a new 
general essential requirement for interoperability with accessories 

clarify  that  the  essential  requirement  in  article  3.2  applies  to  reception 
performance of radio equipment, and include within the scope of the Directive 

45 

46 
47 

e.g. Definitions of common terms like “manufacturer”, “importer”, “placing on the market” set out in 
Article  R2  of  Decision  768/2008  are  introduced  in  the  R&TTE  Directive.  Existing  conflicting 
definitions are removed 
http://www.ero.dk/rtte 
ECO Frequency Information System (EFIS), http://www.efis.dk/ 

EN 

25 

   EN 

 
                                                 
all  equipment  which  intentionally  emits  or  receives  radio  waves;  this  would 
add to the current scope receive-only TV and sound broadcast equipment and 
intentional radiators non-capable of communication 

-Option B3 includes option B1, plus the introduction of additional provisions to deal with 
some  specific  technologies,  an  empowerment  to  the  Commission  to  facilitate  the 
application  of  the  Directive  and  to  address  interoperability  with  accessories,  and  a  scope 
restricted to radio transmitters: 

– 

– 

– 

– 

introduce  specific  provisions  for  software  defined  radio  equipment  and  for 
equipment likely to create cumulative effects (but not for installations) 

confer delegated powers to the Commission on the basis of article 290 TFEU 
in  two  areas  to  introduce  additional  requirements  in  two  areas:  conformity 
assessment of software defined radio equipment, and interoperability between 
specific categories of equipment and accessories  

confer  implementing  powers  to  the  Commission  on  the  basis  of  article  291 
TFEU  to  take  binding  decisions  on  consistent  application  of  the  Directive  to 
future  products  and  technologies  in  matters  such  as  definitions,  scope  and 
requirements 

clarify  that  the  essential  requirement  in  article  3.2  applies  to  transmitters  but 
does not apply to reception performance of radio equipment; include within the 
scope of the Directive intentional radiators non-capable of communication, and 
exclude all receive-only equipment.  

Improvement in the performance of receivers, left outside the essential requirement in article 
3.2,  is  to  be  pursued  through  voluntary  standards  reflecting  the  state  of  the  art.  When 
necessary the Commission may issue standardisation mandates requesting the development of 
such standards 

– 

remove fixed terminals from the scope of the Directive, which would become a 
Directive for radio equipment; leave competition issues affecting terminals to 
general competition law and to Directive 2008/63/EC48 

Both industry and MSAs generally support simplification measures in Option B1, as well as 
adaptations to specific cases in options B2 and B3. Opinions are more divided with regard to 
the  inclusion  of  broadcast  receivers  within  the  scope  of  the  Directive:  manufacturers  are 
clearly opposed, network operators and frequency managers are clearly supportive (see also 
section 7.3, as well as AnnexVI and ref. [12]). 

6.3. 

Options addressing objective C 

-Option C0 is no new EU action.  

-Option C1 includes several non-legislative measures: 

–  to put in place a single point of contact for the request of EU-wide experimental 

licences for use of radio equipment 

48 

COMMISSION  DIRECTIVE  2008/63/EC  on  competition  in  the  markets  in  telecommunications 
terminal equipment 

EN 

26 

   EN 

 
                                                 
–  an action plan led by the Commission to achieve a stronger relationship between 
responsible  entities  within  the  regulatory  framework  for  radio  equipment,  in 
particular  CEPT,  notified  bodies  and  standardisation  bodies.  This  would  include 
measures  such  as  the  systematic  exchange  of  information  on  planning  and 
operational processes, exchange of personnel, co-located meetings, etc 

–  an  information  campaign  improving  awareness  by  companies  and  SMEs  on  the 

regulatory framework for the use of radio equipment 

-Option C2 includes option C1 and two legal changes: the creation of a special category of 
notified bodies, who would give opinions on the more innovative radio equipment, and who 
would  be  required  to  engage  with  CEPT  and  with  ETSI  in  order  to  have  access  to  an 
appropriate level of information; second, the setting up of a central EU body which would 
be  empowered  to  allow  the  placing  in  the  market  and  the  use  of  a  limited  amount  of  radio 
equipment  within  well  defined  geographical  areas  and  periods  of  time,  so  as  to  provide  the 
conditions for a quick commercial start and uptake. The body would be supported by an EU 
level  competence  centre  which  might  be  attached  to  an  existing  body  (e.g.  BEREC49),. 
Temporary  authorisations  could  be  extended,  made  permanent  or  be  reversed,  including  a 
possible withdrawal of previously authorised equipment. 

Industry  and  public  authorities  generally  support  the  measures  included  in  Option  C1. 
Measures in Option C2 have been proposed by individual companies and authorities, but are 
not clearly supported by a category of stakeholders (see also section 7.4 and ref. [11]). 

7. 

ANALYSIS OF IMPACTS  

The  Impact  Assessment  report  uses  data  collected  during  2  public  consultations,  numerous 
formal  and  informal  exchanges  with  stakeholders  and  the  external  study  carried  out  by 
Technopolis  on  the  impacts  of  a  possible  registration  system  for  R&TTE  equipment.  While 
every  effort  has  been  undertaken  to  base  the  proposed  analysis  on  evidence,  it  must  be 
recognized  that  some  data  are  not  available  or  have  not  been  sufficiently  agreed  by 
stakeholders,  in  particular  with  regard  to  the  administrative  costs  and  benefits  of  a  possible 
registration system.  

The impacts of the three respective baseline options have been described in detail in chapter 
4, in particular section 4.8, and will not be repeated here.  They are consistently used as the 
benchmark  for  comparison  of  the  options  involving  new  EU  action  and  are  therefore  also 
included in the summary tables. 

7.1. 

Identifying impacts 

All options will be assessed in terms of effectiveness in achieving the objectives.  

Further,  the  main  impacts  to  be  assessed  are  social  impacts,  driven  by  the  improvement  of 
compliance  with  requirements  protecting  the  the  good  operation  of  communications 
equipment used by consumers, business and public service and the health and safety of users 
and  other  citizens.  Reduction  of  regulatory  barriers  for  innovation  facilitates  access  to  the 
market of new products, enhances consumer choice and increases value-added for consumers. 

49 

Body of European Regulators for Electronic Communications, Regulation (EC) No 1211/2009 

EN 

27 

   EN 

 
                                                 
According  to  present  knowledge,  no  significant  impact  on  employment  of  the  options 
considered can be foreseen. 

Economic  impacts  consist  of  an  improvement  in  the  functioning  of  the  internal  market,  an 
efficient  use  of  spectrum  and  the  administrative  costs  induced  by  the  Directive,  as  well  as 
some  competition  and  innovation  aspects.  Many  of  these  impacts  are  indirect,  driven  by 
intended  improvements  in  simplicity  in  the  operation  of  the  Directive  and  in  legal 
certainty. Specific impacts on SMEs are described as appropriate50. 

Due to the overall limited impact on the costs resulting from the options considered, it is not 
expected  that  it  creates price  increases  that  may  negatively  affect  consumers.  If  on  specific 
products moderate price increases were nevertheless to materialise, in particular under options 
B2  and  B3,  it  is  expected  that  the  latter  would  be  largely  offset  by  the  benefit  of  greater 
reliance on the product quality. 

With regard to environmental impacts, disposal of R&TTE equipment is already regulated 
by a number of existing pieces of legislation (see section 3). Options considered in this report 
do not present significant environmental impacts. 

7.2. 

Options  addressing  objective  A:  To  achieve  improved  enforcement  and 
compliance with the Directive 

Four impacts are relevant here: impact on compliance – and through compliance on the social 
benefit of improved and safe operation of equipment-, administrative costs for companies and 
administrations, direct cost of a registration system, and impact on trade with third-countries.  

7.2.1.  Effectiveness: 

In spite of significant efforts undertaken by the Commission together with Member States and 
economic  operators  in  order  to  assess  the  impact  on  compliance  of  the  different  options51, 
views  on  this  matter  of  different  stakeholders  have  remained  very  divergent.  Furthermore, 
though product registration applies to different subsets of radio equipment in countries such as 
US,  Canada  and  Singapore,  they  do  not  provide  information  on  resulting  levels  of 
compliance.  It  is  therefore  important  to  explain  which  and  to  what  extent  elements  in  each 
option contribute to improved compliance. 

Option A1 – alignment of the Directive to the NLF 

The  improved  legal  tools  (obligations  of  importers  and  distributors,  traceability,  safeguards, 
penalties)  intend  to  increase  the  effectiveness  of  enforcement  by  MSAs.  Stakeholders  have 
provided the following estimation of the impact of the NLF alignment on compliance: 

–  Some  50%  of  Member  States  and  most  economic  operators  expect  a  high  impact  of  the 
alignment to the NLF on compliance in the R&TTE area (see ref. [9]). In the course of the 
2010  public  consultation  a  majority  of  respondents  expected  from  the  NLF  alignment  a 
medium (43%) to strong (28%)  impact  on  compliance.  SMEs were equally positive with 
60% indicating a medium impact and 12% a strong impact (see ref. [12]) 

50 
51 

An overview (SME-test) can be found in Annex XII.  
These efforts included a study commissioned to an independent consultant, see reference [8] 

EN 

28 

   EN 

 
                                                 
–  A similar fraction of Member States (ca 50%) considers that, taking into account current 
difficulties  to  allocate  more  resources  to  market  surveillance,  in  the  absence  of  other 
instruments allowing to improve efficiency of MSAs only a limited positive improvement 
with regard to the current situation can be expected (see ref. [9]) 

With regard to the growing share of imports in the R&TTE area, the obligations of importers 
and  distributors  to  check  that  appropriate  conformity  assessment  has  been  carried  out,  and 
their  role  in  providing  feedback  on  enforcement  measures  (e.g.  market  withdrawals)  are 
expected to have a positive impact on compliance by manufacturers based outside the EU. In 
addition  to  this,  improving  cooperation  between  EU  authorities  and  those  in  the  main 
exporting countries, i.e. China, US, Japan and Korea (see Annex III) is also necessary in order 
to  educate  extra-EU  manufacturers  and  importers  and  to  dissuade  them  from  placing  non-
compliant  products  on  the  EU  market.  Considering  the  divergence  of  economic  interests 
among trading partners, a significant additional contribution to compliance as a result of such 
cooperation is however uncertain. 

Taking into account the elements above, the conclusion is that this option should provide an 
improvement of compliance ranging between moderate and significant. 

Option  A2  –  NLF  alignment  +manufacturer  registration  -  includes  two  additional  elements 
for  MSA  efficiency  on  top  of  option  A1:  the  online  availability  of  up-to-date 
manufacturer’s  contact  data  in  a  central  database  facilitates  a  reduction  of  delay  in 
contacting manufacturers responsible for R&TTE products; as the contact data are not product 
specific, the reduction would in some cases be more effective than in others. Also, MSAs can 
easily withdraw from the market products without manufacturer registration number. 

The  additional  effect  on  the  efficiency  of  MSAs  and  therefore  on  compliance  should  be 
positive but limited, as seen by most MSAs (see ref. [9]).  

Option A3 - NLF alignment + product registration - provides improved efficiency in market 
surveillance and has an educational impact on manufacturers:  

First, product registration provides quick access to the technical file of registered products; 
this should allow in most cases to check whether conformity assessment has been performed 
or  not.  When  necessary,  online  availability  of  product-specific  manufacturer’s  contact 
data in a central database facilitates a reduction of delay in obtaining further details about the 
process.  Though  no  common  picture  of  the  potential  improvement  could  be  obtained,  one 
MSA provided the following estimation (see ref. [9]): 

– 

Difficulties for contacting the responsible entity arise in 50% of the cases, entailing a 
time effort ranging between 0.25 and 0.75 manXdays. Taking into account time spent 
analysing the technical documentation and planning lab tests (average 1.5 days), the 
MSA estimates an overall gain of up to 10-15% in time/resources allocated to market 
surveillance.  Product  registration  also  allows  to  eliminate  the  current  delay  for 
obtaining the technical documentation for the product, which is currently estimated 
to  be  of  4  weeks  on  average,  and  therefore  reaction  time  of  MSAs  would  be 
improved by several weeks. 

Second,  product  registration  allows  MSAs  to  easily  detect  and withdraw from the market 
non-registered products, and products identified as non-compliant. 

EN 

29 

   EN 

 
Third, on the basis of the aggregate set of registered products, MSAs obtain an overview of 
the  market  to  be  surveyed.  This  allows  devise  programmes  for  market  surveillance 
accordingly, and to request appropriate means from budgetary authorities 

Fourth,  a  user-friendly  online  product  registration  tool  obliges  manufacturers  to  go  step  by 
step  through  all  necessary  regulatory  steps  specific  to  each  product.  This  is  expected  to 
improve  awareness  by  manufacturers  of  their  obligations  under  the  Directive,  and  is 
particularly relevant for the majority of manufacturers located outside the EU. 

Respondents  to  the  2010  stakeholder  assessed  the  impact  of  product  registration  on 
compliance  as  medium  31%  (48%  for  SMEs)  or  significant  34%  (18%  for  SMEs).  The 
incentive matrix with which manufacturers are confronted evolves with option 3: 

Table 3. Evolved incentive matrix for compliance under R&TTE Directive under option 3 

Barrier/Incentive 
compliance 

for 

Probability of effective sanction in 
case of non compliance 

High 

Low 

Perceived 
cognitive  barrier 
to compliance 

High 

Low 

The  new  matrix  is  characterised  by  a  lower  perceived  cognitive  cost  of  compliance,  and  a 
higher risk of sanctions in case of non-compliance. The change in the incentive matrix should 
drive compliance further up from the levels attained with options A1 and A2. Some allowance 
for inefficiency and forgery in the product registration system itself should however moderate 
the increase in compliance resulting from this option.  

Option A4 should have similar impact as Option A3 on effectiveness addressing compliance 
in  those  equipment  categories  which  become  subject  to  product  registration.  For  other 
equipment categories, impact of effectiveness is similar as for Option A1. As Option A4 only 
brings  in  the  obligation  to  register  products  for  those  categories  where  a  high  level  of 
compliance has not been attained, a better cost/benefit ratio is expected.  

7.2.2. 

Impact on administrative costs 

Option  A1  entails  some  additional  administrative  costs,  resulting  for  example  from  the 
obligation  of  economic  operators  to  keep  a  register  of  suppliers  and  buyers  of  equipment, 
which are perceived as non-problematic by manufacturers (see ref. [9], [12]52). 

With  regard  to  Option  A2,  manufacturers  consider  that  effort  associated  to  a  one-time 
registration of the manufacturer itself would be negligible. Adding an additional manufacturer 
ID to all products would create design problems since there are already many global labelling 
requirements and limited space on product labels (see ref. [9]).  

52 

16% of all respondents (30% of SMEs) of the 2010 public consultation indicated no or no significant 
administrative burden; 45% (38% of SMEs) indicated some administrative burden linked to option A1  

EN 

30 

   EN 

 
 
 
  
 
 
 
 
                                                 
The  impact  of  Option  A3  on  administrative  burden  is  perceived  as  much  more  significant 
than  for  the  other  options.  32%  respondents  to  the  2010  consultation  (but  only  12%  of 
SMEs53)  assess  the  impact  as  significant  against  only  10%  for  the  NLF  alignment.  Main 
burdens generated by this option are the following (see ref. [9]): 

– 

– 

– 

– 

– 

Training  staff  to  become  acquainted  with  the  system:  this  is  a  one-time  investment, 
also common to option A2 above, and not considered significant by industry 

Upload manufacturer information, obtain manufacturer Id and a range of product Ids. 
This is again considered not significant by industry  

Upload  product  specific  information:  this  implies  selecting  appropriate  information, 
formatting, performing confidentiality checks and actually uploading the information. 
This  is  considered  to  be  significant  by  industry,  actual  effort  would  depend  on  the 
precise subset of technical documentation required  

Manage correspondence between product Id, technical file and product labelling: this 
is again considered significant. In the case of supply chains involving subcontractors, 
this may imply revision of legal agreements in order to allocate responsibilities under 
the product registration scheme 

Design  equipment  to  accommodate  a  new  label,  and  organise  production  to  ensure 
correspondence  between  products  and  product  Ids.  This  is  considered  problematic, 
mainly  because  of  already  existing  labelling  requirements  in  the  EU  and  other 
economic areas, and the limited space on products 

Manufacturers have not been able to provide a systematic estimation of resources required to 
cope with these tasks. Both written and oral requests on behalf of the Commission to provide 
such  estimation  were  declined  by  companies  and  industry  associations54.  Some  elements 
gathered were the following:  

– 

– 

– 

– 

For a large manufacturer with many products, industry representatives indicated that 
the additional workload could mean several additional full-time staff. (see ref. [9]). 

A  large  manufacturer  indicated  the  need  to  recruit  2  additional  employees,  an 
additional cost of ca. 1500000 €/year to cope with obligations under Option A3.  

Additional  burden  is  expected  to  be  lesser  for  SMEs  with  fewer  products  on  the 
market  and  for  whom  the  operation  of  the  system  presents  less  challenges  of 
complexity (see ref. [8]) 

Additional burden arising from collecting, formatting and uploading product specific 
information  seems  to  derive  from  the  way  in  which  companies  comply  in  practice 
with their obligations under the Directive: 

“It seems that while firms (especially large companies) collect all necessary data as expected 
by the regulation when a new product is introduced onto the market, they do not edit a fully 

53 
54 

This might be linked to the fact that they produce less different types of products 
A first systematic effort was conducted by Technopolis, see ref. [8], a second by TCAM ad hoc group 
on Traceability and Compliance, see [9], several direct Commission contacts were also undertaken with 
manufacturers in 2010 and 2011  

EN 

31 

   EN 

 
                                                 
comprehensive  report  every  time.  Rather,  and  although  manufacturers  have  all  information 
on their databases, such fully comprehensive reports are only edited ‘on demand’, i.e. when 
an MSA asks for the required information. That way, the companies in question save the work 
to  actually  produce  reports  in  most  cases  (i.e.,  the  work  needed  to  copy  and  paste  the 
information,  create  table  of  contents  etc.)  and  are  able  to  implement  higher  ‘internal’ 
(information)  security  standards  (e.g.,  by  implementing  separate  access  barriers  for  certain 
employees to certain types of information). The additional time needed is seen in this context 
in  the  need  to  hire  extra  persons  only  tasked  to  handle  the  creation  of  the  reports,  and  the 
extra time needed to assemble the information in a readable way. Additional costs would be 
negligible if the companies were to create the Documentation in such a way every time, i.e. 
also  when  no  MSA  is  requiring  the  information  (which  is  what  many  MSAs  seem  to  expect 
from the companies). However, in practice cost increases would occur (although they would 
likely also be present if the current system could be enforced more stringently). (see ref [8]) 

Should the current obligation to establish a technical file prior to the placing of a product on 
the market be systematically fulfilled, additional costs would be limited. 

There is no impact on time to market: provision of a pool of product Ids to a company can be 
done  in  advance,  allowing  companies  to  plan  for  their  use.  Product  registration  can  be 
designed to integrate existing notifications as per article 6.4 (see section 4.2.4 above), so that 
registration facilitates market access without additional procedures. 

An obligation to register products as in option A3 is already in place in countries such as US, 
Canada and Singapore. In view  of  their experience, no relevant impact on product diversity 
and consumer choice in the EU market is foreseen. 

For Option A4, additional administrative burden linked to product registration (i.e. training, 
formatting  and  upload  of  information,  labelling,  etc)  would  only  apply  for  those  product 
categories  required  to  apply  registration,  i.e.  those  showing  persistently  low  compliance 
levels. The total administrative costs would therefore be much more limited than for Option 
A3. As Option A4 targets problematic product categories and implies less burden for industry 
as a whole, its overall efficiency is expected to be higher than for Option A3. 

7.2.3.  Direct costs of the options 

Options A2, A3 and A4 entail direct costs for the implementation and maintenance of a 
registration system. A conservative estimate of these costs for option 3, implying the most 
complex  system  yields  estimated  investment  costs  of  300000  €  and  estimated  annual 
maintenance  costs  of:  30000  €  ( see  Annex  X  for  the  assumptions  considered).  A  system 
limited  in  scope  to  some  categories  of  products,  as  in  Option  A4,  would  of  course  imply 
lower  costs;  the  reduction  need  not  be  proportional.  As  for  the  system  in  option  A2,  costs 
would be very limited. 

7.2.4. 

Impact on third countries:  

Some 80% of equipment placed on the EU market is manufactured abroad, and manufacturers 
outside  the  EU  would  have  to  comply  with  an  obligation  to  register  in  case  the  relevant 
options  are  adopted.  In  the  case  of  option  A4,  observed  low  compliance  shows  that  some 
categories  of  low-cost  products  manufactured  in  East  Asia  might  become  subject  to 
registration. Associated administrative burden and cost would particularly apply to them.  

A Commission proposal to introduce registration in the R&TTE area would have an impact 
on the role of the EU as an effective model of liberal regime in the area of technical barriers to 

EN 

32 

   EN 

 
trade.  Introducing  registration  in  the  R&TTE  area  may  be  perceived  as  questioning  the 
effectiveness of the New Approach regime in protecting public interests, and could make less 
attractive the adoption of the EU regulatory approach by our trading partners. 

7.2.5.  Comparing the options addressing objective A. Preferred option 

The table below summarises the impacts assessed55. 

As  a  summary,  the  alignment  to  the  NLF  and  the  improved  cooperation  among  MSAs 
(Option  A1)  should  increase  compliance  with  limited  increases  in  administrative  cost.  The 
simplification measures considered below under objective B should further contribute to the 
improvement  of  compliance.  Manufacturer  registration  as  per  Option  A2  provides  only 
limited value-added to market surveillance tasks. Full product registration as per Option A3 
may provide significant improvement of effectiveness and efficiency of market surveillance, 
but is perceived by industry as a significant additional burden. Option A4 allows to adopt a 
flexible and proportional approach: to perform the alignment of the R&TTE Directive to the 
NLF, and to introduce registration in some specific product categories where a high level of 
compliance has not been attained as shown by careful examination. Option A4 provides the 
best balance between the social benefit of improved compliance and the economic imperative 
to avoid unnecessary burden, and is therefore the preferred option. 

Table 4. Summary table comparing options addressing objective A 

Effectiveness  in 
achieving 
objective A 

0 

+/++ 
Moderate to 
significant 

Option A0 

Option A1 

Option A2 

+/++ 

Option A3 

Option A4 

Limited impact on 
top of A1 

+++ 
Additional 
instrument for 
effective 
enforcement of 
obligations and 
education of 
companies 

++ 
Additional 
measures only for 
problematic 
categories 

Cost and efficiency  Coherence 

0 

0 

- 
Increase of 
administrative 
requirements, in 
particular for importers 
and distributors 
-/+ 
Perceived as a small 
increase of burden by 
manufacturers 
Limited improvement in 
the efficiency of MSAs 
--/++ 
Perceived as a significant 
increase of burden by 
manufacturers 
Improves efficiency of 
MSAs 
Estimated 300000€ 
investment 
-/+++ 
Smaller increase in 
burden for industry than 
Option A3 
Higher overall efficiency 
than Option A3 

+++ 
NLF alignment 
improves coherence 
with other New 
Approach legislation 

+++/- 
Idem NLF / 
Slight depart from 
New Approach 
legislation 

+++/-- 
Idem NLF /  
Departs from New 
Approach legislation 

+++/- 
Idem NLF / 
Departs from New 
Approach legislation 
in justified cases 

55 

For  the  assessed  impact  of  the  options,  the  symbols  are  to  be  read  as  follows:  0  no  impact,  +  weak 
positive,  ++  moderate  positive,  +++  significant  positive,  -  weak  negative,  --  moderate  negative,  --- 
strong negative 

EN 

33 

   EN 

 
 
 
                                                 
7.3. 

Options  addressing  objective  B:  To  make  available  a  sound  legal  basis  for  the 
implementation of the essential requirements 

7.3.1.  Effectiveness. 

Option B1: the NLF intends, among other objectives, to clarify and to bring consistency to 
many definitions and obligations common to New Approach legislation such as the R&TTE 
Directive. This is an aspect which benefits from an important consensus among the R&TTE 
constituency  (see  ref.  [10]).  Avoiding  current  confusion  between  the  obligation  to  affix  the 
alert sign and the obligation to notify equipment using non-harmonised bands (article 6.4) is 
important  for  manufacturers,  as  shown  by  numerous  discussions  within  TCAM.  We  may 
therefore speak of a significant clarification and improvement of coherence from Option B1. 

Many Member States use notifications in article 6.4 to communicate with  manufacturers on 
applicable  spectrum  regulation,  and  to  identify  needs  for  further  spectrum  harmonisation. 
Suppression  of  this  communication  channel  is  to  be  compensated  by  currently  ongoing 
improvements in information provided to manufacturers by the list of R&TTE equipment sub-
classes,  which  provide  information  on  available  restrictions  to  use,  in  the  EFIS  database, 
which  provides  some  information  on  spectrum  allocation  and  designation  at  European  and 
national  level  but  which  is  yet  incomplete  and  not  up-to-date,  and  by  other  non-legislative 
measures considered under objective C in section 6.3. 

Option  B2,  with  the  introduction  in  the  Directive  of  provisions  specific  to  the  cases  of 
software  defined  radio,  installations  and  cumulative  effects,  provides  in  general  companies 
and  authorities  with  a  clearer,  more  fit-for-purpose  legal  basis.  Specific  issues  and  possible 
drawbacks to take into account are the following: 

• 

• 

• 

In the area of software defined radio, there are yet important unknowns about 
the  actual  risks  created  by  software  uploads,  about  the  future  extent  of 
competition in the provision of third-party software, and in general about future 
technology and its market uptake. New provisions may not be future-proof 

Installations  are  not  placed  on  the  EU  market.  There  is  less  value-added  in 
harmonising legislation applicable to them than it is the case for products. Co-
existence  with  national  legislation  for  installations  may  still  be  necessary  in 
many cases, making the case for harmonisation weaker 

A  general  requirement  for 
interoperability  with  accessories  may  be 
inapplicable  due  to  disagreements  within  industry  on  technology.  Systematic 
intervention by the Commission would mean a counterproductive interference 
with technology choices in the market 

Option B2 brings the benefit of unifying interpretation of the essential requirement 3.2, which 
would  include  performance  of  reception.  This  facilitates  the  task  of  ETSI  in  developing 
harmonised  standards,  and  also  allows  to  plan  a  more  efficient  use  of  spectrum.  This  is 
important in view of the increased demand for this scarce resource, and in particular for the 
coexistence  in  the  same  bands  of  broadcast  services  and  other  electronic  communication 
services. It ensures that consumers only have access to receivers with sufficient performance 
to  work  properly  in  situations  of  intense  use  of  spectrum,  and  therefore  brings  the  social 
benefit of protecting user experience. This approach is strongly supported by mobile network 
operators  and  by  spectrum  authorities  (see  ref.  [12]).  Including  within  the  scope  of  the 

EN 

34 

   EN 

 
Directive intentional radiators non-capable of communication and broadcast receivers brings 
under  the  same  legislation  all  equipment  concerned  by  the  essential  requirement,  which 
allows  to  unify  requirements  on  equipment  using  spectrum  for  different  purposes  and 
simplifies market surveillance. 

Option B3 brings in the benefits of option B2 with regard to application of the Directive to 
challenging  technologies,  but  tries  to  avoid  its  drawbacks  through  the  use  of  Commission 
implementing  and  delegated  powers,  allowing  to  timely  react  to  future  developments  in 
technology or in the market. This is particularly valuable in the case of software defined radio, 
where the technology and the forms of cooperation between manufacturers of hardware and 
software  are  yet  to  be  developed.  With  regard  to  interoperability  with  accessories,  the 
possibility  in  option  B3  to  introduce  requirements  in  the  future  provides  an  incentive  to 
market  actors  to  solve  the  issue  by  themselves,  thus  making  EU  intervention  exceptional, 
which is desirable in order to avoid hampering innovation. 

Option B3 also brings the benefit of unifying interpretation of the essential  requirement 3.2 
with  regard  to  reception,  though  in  a  different  direction  than  in  option  B2:  the  requirement 
would  not  be  applicable  to  receive-only  equipment,  which  would  be  excluded  from  the 
Directive. Performance of receivers would be left to voluntary standards and to the market, as 
it is currently  taking  place  for  co-existence of services in the 800  Mhz  band. This  option is 
clearly  preferred  by  manufacturers  (see  ref.  [12]).  In  the  context  of  a  more  intense  use  of 
radio  spectrum,  some  consumers  having  purchased  underperforming  receivers  may  suffer  a 
degradation of their experience.  

Again,  bringing  within  the  scope  of  the  Directive  intentional  radiators  non-capable  of 
communication brings under the same legislation all equipment intentionally using spectrum 
and  therefore  concerned  by  avoidance  of  interference,  which  unifies  requirements  and 
simplifies market surveillance.  

In  addition,  Option  B3  unifies  and  simplifies  the  legal  framework  for  fixed  terminals  (see 
4.2.2), which would be the EMCD56 and the LVD57 (or GPSD58 in some cases). The R&TTE 
Directive would become a simpler Directive on Radio Equipment with a clearer scope. A side 
effect  of  this  simplification  is  to  remove  the  possibility  of  introducing  additional 
interoperability  or  accessibility  requirements  for  fixed  terminals  and  for  pure  receivers  (e.g. 
Galileo/GPS receivers) on the basis of currently applicable article 3.3. 

7.3.2. 

Impact on administrative and compliance cost 

Alignment  with  the  NLF  (Option  B1)  involves  some  reduction  of  administrative  cost  for 
manufacturers (see table below). 

Other  elements  in  Option  B1  further  provide  reduction  of  administrative  cost  for 
manufacturers.  Suppressing  article  6.4  has  been  referred  in  the  context  of  the  2010  public 
consultation  (see  ref.  [12])  as  a  significant  reduction  of  burden.  Less  important  was 
considered  the  suppression  of  the  Alert  Sign.  SME  participating  in  the  consultation  did  not 
present any specificity in their valuation of this impact. 

56 
57 
58 

See footnote 29 above 
See footnote 30 above 
See footnote 32 above 

EN 

35 

   EN 

 
                                                 
Table 5. Administrative obligations under Current R&TTE Directive and NLF 

Administrative  obligations  for 
manufacturers 

Option B0 -  

Current R&TTE D 

 -CE marking 

-Notified Body number 

-Alert Sign 

-Manufacturer's name, product id, 
unique id 

-Indication of the countries where 
the equipment is to be used 

-Indication of restrictions of use 

-Indication of relevant interfaces for 
use 

-Provision of a DoC with the 
product 

-Prior notification of equipment 
using non-harmonised bands 

3x:(equipment, package, user 
instructions) 

3x:(equipment, package, user 
instructions) 

3x:(equipment, package, user 
instructions) 

1x (equipment) 

2x (package, user instructions) 

1x 

1x 

1x 

-required 

Option B1 (NLF) 

1x : (equipment) 

1x : (equipment) 

1x (equipment) 

not required 

Option  B2  creates  some  additional  compliance  cost  for  manufacturers  of  software  defined 
radio, i.e. an obligation to introduce mechanisms which ensure that only compliant software is 
uploaded,  and  for  installers  of  fixed  installations  if  explicitly  covered  by  the  Directive. 
Systematic  requirements  on  interoperability  with  accessories  may  bring  in  important 
transitional costs for manufacturers obliged to adapt to new technical specifications. 

Under option B2, a number of R&TTE D obligations would become applicable to intentional 
radiators and to broadcast receivers, what entails some compliance costs (see table below). 

–  complying with the essential requirement in article 3.2 may entail some additional 
testing and costs, ranging between quasi-nil for those products already subject to 
comprehensive testing, and a range of 2000-4000 EUR59 per product type where 
the  manufacturer  opts  for  the  introduction  of  external  testing  in  order  to  assess 
compliance  with  the  requirement.  In  the  short  term,  in  the  absence  of  specific 
harmonised standards for these products, the opinion of a notified body would be 
required, with additional costs ranging between 500 and 1500 EUR60 per product 
type.  An  appropriate  mitigation  measure  to  avoid  such  worst-case  situations 
would be an additional delay for implementation allowing for the development of 
harmonised standards which would make consultation of a notified body optional 
–  the R&TTE Directive removes the voltage limitation (50 AC, 75 DC) of the LVD, 
therefore  the  LVD  safety  requirements  are  of  application.  Manufacturers  have 
indicated that this entails additional testing and costs. However, under the GPSD 
safety  of  products  also  has  to  be  tested  and  therefore  the  change  of  applicable 
legislation should only bring some limited additional administrative cost  

The impact of these additional compliance costs on individual products may be estimated as 
ranging  between  practically  nil  for  products  which  already  are  comprehensively  tested  by 
manufacturers and up to 50 € in the extreme cas e of products sold in small quantities when 

59 
60 

source: direct targeted consultation of some notified bodies by Commission services 
source: direct targeted consultation of some notified bodies by Commission services 

EN 

36 

   EN 

 
 
 
 
 
 
 
 
 
 
                                                 
full  testing  and  the  opinion  of  a  notified  body  is  newly  required.  (see  Annex  XI  for  the 
assumptions  considered).  Leaving  aside  exceptional  situations,  those  products  for  which 
lower  quantities  are  sold  are  also  products  incorporating  higher  value  added  and  more 
expensive  products,  therefore  the  possible  increase  in  prices  is  not  substantial  in  relative 
terms, even in the absence of mitigation measures. Sufficient delays for the entry into force of 
the  new  scope  should  in  practice  eliminate  the  need  for  manufacturers  to  contract  external 
testing and to consult with notified bodies, leaving them the option to declare conformity on 
the basis of harmonised standards and in-house tests. 

As for additional administrative burden: 

–  article  6.3  obliges  to  provide  the  DoC  with  the  product;  this  obligation  can 

currently be fulfilled in the form of a standard simplified DoC 

–  article 6.3 obliges to provide information to the user on available interfaces, on the 
geographical area for intended use of radio terminals (and on possible restrictions 
to use, not applicable to broadcast receivers) 

–  one-time costs for referring to the R&TTED in the DoC of product types already 
present  on  the  market  under  EMCD  and  LVD/GPSD;  an  additional  delay  for 
implementation limits the need for this adaptation to product types not phased out 
by manufacturers within the given delay 

Table  6.  Additional  requirements  under  R&TTE  Directives  compared  to  EMCD  + 
LVD/GPSD 

R&TTE D requirements additional to EMCD + LVD/GPSD 

Substantive 
requirements 

Administrative 
obligations 

-essential requirement 3.2 (avoidance of harmful interference) 

-safety requirements of LVD apply also for equipment outside the 50V-1000V AC 
/ 75V-1500V DC voltage range, in particular for battery-powered equipment 

-provide the DoC with the product 

-inform the user about available interfaces and geographical areas for use  

-alert on restrictions to use (not applicable to pure receivers) 

Negative impacts on cost and burden with regard to broadcast receivers were highlighted by a 
majority of manufacturers during the 2010 public consultation, where no specific SME issues 
where apparent.  

The  use  of  delegated  powers  in  option  B3  allows  to  limit  additional  cost  generated  by 
requirements on SDR equipment and on interoperability with accessories to those cases where 
the benefits are clearly justified. Option B3, like option B2, would create some additional cost 
for intentional radiators non capable of communication, which would fall under the scope of 
the  R&TTE  Directive  (see  above  the  discussion  of  additional  cost  for  broadcast  receivers 
under option B2) . This option would reduce some administrative cost for receive-only radio 
equipment and for fixed terminals which would become excluded from the scope of Directive. 

7.3.3.  Comparing the options addressing objective B. Preferred option 

The table below summarises the impacts assessed above: 

In  summary,  Option  B1  achieves  clarification,  simplification,  reduction  of  burden  and 
improvement  of  coherence.  Option  B2  further  clarifies  and  improves  the  legal  basis  in 
dealing  with  SDR,  intentional  radiators  and  receivers.  Requirements  on  performance  of 
reception  may  be  used  to  increase  efficiency  in  the  use  of  spectrum  and  improving  user 

EN 

37 

   EN 

 
 
experience, but entailing additional compliance and administrative costs. Option B3 allows to 
clarify the application of the Directive to current and future specific cases, sets clear criteria 
for its scope in relation to the EMCD, and reduces or avoids regulatory requirements on the 
performance of receivers and associated compliance costs, leaving performance of receivers 
to the choice of manufacturers and consumers. It provides a good balance between protecting 
the  good  operation  of  radio  equipment  by  consumers,  businesses  and  public  services  and 
avoiding  to  regulate  issues  which  may  be  left  to  the  market,  Option  B3  is  therefore  the 
preferred option. 

Option B3 is therefore the preferred option. 

Table 7. Summary table comparing options addressing objective B 

Option B0 

Option B1 

Option B2 

Option B3 

Effectiveness in 
achieving 
objective B 
0 
-Guide to the Directive 
provides non-binding 
interpretations 
++ 
-Significant 
clarification of existing 
provisions 

++/- 
-Clarifies application 
of the Directive to 
specific technologies 
-Limited value-added 
of a EU-wide 
legislation for 
installations. 
-A general requirement 
for interoperability 
with accessories may 
be inapplicable due to 
disagreements within 
industry 
-Improves legal 
certainty bringing all 
receivers under the 
R&TTE 
-Improves protection of 
spectrum bringing all 
intentional radiators 
under the R&TTE D 
+++ 
-Commission powers 
allow to react to 
technology/ market/ 
legal issues arisen 
during application of 
the Directive 
-Improves legal 
certainty bringing all 
receivers and all fixed 
terminals under the 
EMCD 
-Improves protection of 

Side effects 

Cost and 
efficiency 

Coherence 

0 
-Different 
approaches among 
Member States 
++ 
-Improves 
coherence with 
other internal 
market legislation 
and the Regulatory 
Framework for 
Electronic 
Communications 

0 

0 

+ 
-Improved 
compliance 
(objective A) 
-Removing article 
6.4 may reduce 
information to 
manufacturers on 
spectrum 
regulation 
+/- 
-May be used to 
deal with receiver 
aspects in 
improving 
efficiency in the 
use of spectrum 
-A general 
requirement for 
interoperability 
with accessories 
may deter 
innovation 

++ 
Some reduction 
of administrative 
requirements 

-- 
-Some additional 
cost for SDR 
manufacturers 
and for 
installators 
-Additional cost 
due to general 
interoperability 
obligation 
-Some additional 
cost for 
manufacturers of 
broadcast 
receivers and 
intentional 
radiators non 
capable of 
communication 

- 
-Requires other 
measures to 
support efficient 
use of spectrum by 
receivers, e.g. 
voluntary standards 
Removes 
application of 
additional essential 
requirements 3.3 to 
fixed terminals and 
receive-only 

+/- 
-Some additional 
cost for SDR 
manufacturers 
-Some additional 
cost for 
manufacturers of 
intentional 
radiators non 
capable of 
communication 
-Some reduction 
of cost for 

++ 
-Improves 
coherence with 
other EU 
legislation on 
competition issues 
for terminals 

-Implementing 
powers facilitate 
consistent 
application of the 
Directive across the 

EN 

38 

   EN 

 
 
 
 
 
 
 
 
spectrum bringing all 
intentional radiators 
under the R&TTE 

equipment (e.g. 
GPS/Galileo 
receivers) 

manufacturers of 
receive-only 
equipment and of 
fixed terminals 

EU 

7.4. 

Options addressing objective C: to remove regulatory barriers to innovation in 
radio equipment 

7.4.1.  Effectiveness. 

It  is  important  to  remind  that,  according  to  the  report  of  the  TCAM  ad  hoc  group  on 
innovation (see ref. [11]), the R&TTE Directive does not present major barriers to the use of 
radio equipment, it is in the area of regulation for the use of spectrum where the main issues 
lie, and the EU has already addressed and continues to address these issues within its Radio 
Spectrum Policy.  

The  non-legislative  elements  in  Option  C1  are  expected  to  improve  awareness  among 
innovators of the regulatory system and to achieve better coordination of the current processes 
necessary  for  the  placing  on  the  market  and  putting  into  service  of  radio  equipment.  This 
entails a reduction of delays to accommodate novel products within the regulatory framework 
and  to  bring  them  to  the  market  (see  ref.  [11]).  Taking  into  account  the  nature  of  these 
elements, improvements are expected to be incremental rather than radical with regard to the 
current situation.  

Option C2 introduces a regime for temporary authorisation of the commercialisation and use 
of radio equipment. This regime would provide a visible EU-wide focal point for innovators 
and would allow a significant reduction in time-to-market, of up to 1-2 years in some cases. 
However,  industry,  in  particular  larger  companies,  is  reluctant  to  invest  in  commercial 
deployment  without  regulatory  certainty  (see  ref.  [11]).  Coherence  with  the  current  process 
for  assessing  technical  compatibility  of  use  of  spectrum  is  also  an  issue,  in  particular 
regarding  overlaps  between  the  new  competence  centre  supporting  the  regime  and  CEPT, 
which is currently in charge of formal compatibility assessments. Empowering a central EU 
authority  to  issue  authorisations  for  the  use  of  spectrum  also  raises  subsidiarity  issues  with 
regard to national competences in this area. 

As for the creation of a special category of notified bodies, this could facilitate that innovative 
equipment  receives  opinions  with  sufficient  credibility  among  authorities.  A  foreseeable 
drawback  is  the  possible  degradation  of  the  perceived  value  of  opinions  issued  by  ‘normal’ 
notified bodies not belonging to the special category, leading to distortions of competition. 

7.4.2.  Administrative and other costs 

Option  C1  involves  investment  in  an  Internet  portal  for  experimental  licensing61  and  in  an 
information campaign, which could take place in the context of communication on the revised 
R&TTE  Directive.  Improved  communication  between  CEPT,  notified  bodies  and 
standardisation  bodies,  and  better  information  of  companies  and  SMEs  should  bring 
efficiency improvements for all stakeholders and largely compensate for those investments. 

Option  C2  involves  the  creation  of  new  procedures  for  accreditation  and  monitoring  of  a 
special category of Notified Bodies, in parallel to existing procedures. This implies additional 

61 

In principle to be funded by Member States and/or CEPT, not by the EU  

EN 

39 

   EN 

 
                                                 
cost for notified bodies and may imply additional human resources in public authorities (0-2 
additional headcount per national authority is an estimation – source: Commission services). 

Also  within  Option  C2,  a  European  competence  centre  advising  the  central  EU  body  on 
temporary  authorisations  would  need  to  be  staffed,  a  headcount  of  10  persons  full-time  is  a 
lower  estimate62.  Withdrawal  from  the  market  of  temporarily  authorised  equipment  may  be 
impossible or require very substantial costs for authorities (see ref. [11]). 

7.4.3.  Comparing the options 

The following table summarises the impacts assessed above: 

Table 8. Summary table comparing options addressing objective C 

Option C0 

Option C1 

Option C2 

Effectiveness in 
achieving 
objective C 
0 

+ 
-Incremental 
improvement of 
regulatory delays in 
access to the market 
for innovations 
+/++ 
-Improves 
credibility of 
opinions of 
‘special’ NBs 

-Important 
reduction of 
regulatory delays in 
access to the market 
-Temporary 
authorisation not 
attractive for 
commercial 
investment 

Side effects 

Cost and 
efficiency 

Coherence 

0 

0 

0 

-- 
-Special category of 
NBs may distort 
competition among 
notified bodies 

- 
-Important practical 
difficulties in 
reversing temporary 
commercial 
authorisations 

+ 
-Some additional 
administrative costs 
-Incremental 
efficiency 
improvements 
-- 
Important costs to 
consider: 
-Operation of new 
scheme for 
accreditation of a 
special category of 
NBs 
-Set up of a new 
competence centre 
for temporary 
authorisations 
-Withdrawal of 
previously 
authorised 
equipment may be 
very expensive 

+ 
-Improves 
coherence of the 
current institutional 
arrangement 

-- 
-Special category of 
NBs is not foreseen 
in NLF 

-Double regime for 
authorisations, 
uncertainty among 
incumbent users of 
spectrum 

-Overlaps current 
role of CEPT 
-Raises subsidiarity 
issues 

Option  C1  provides  incremental  improvements  in  time-to-market  and  efficiency  gains  for 
economic operators, regulators and other entities. Option C2 provides shorter time–to-market 
but  involves  non-negligible  additional  costs,  as  well  as  some  institutional  drawbacks  and 
uncertainties  with  regard  the  benefits  for  industry  of  temporary  equipment  authorisations. 
Option C1 is therefore the preferred option. 

8. 

PREFERRED OPTIONS 

On the basis of the analysis in chapter 7, the recommended package includes options A4, B3 
and C1: 

The  combination  of  options  A4  and  B3  allows  to  increase  compliance  through 
simplification and clarification of the requirements in the Directive and the improvement of 

62 

For reference, ECO, the Secretariat of CEPT, employs a staff of 14 people including 7 experts 

EN 

40 

   EN 

 
 
 
 
 
 
 
                                                 
the  legal  instruments  for  enforcement.  The  NLF  alignment  implies  a  moderate  increase  of 
burden, in particular for importers and distributors. Option A4 also allows the Commission to 
introduce  product  registration  for  specific  product  categories  if  required  by  persistently  low 
levels of compliance, additional burden would only apply to these categories. 

Option B3 provides clarification and simplification in the legal text and a few administrative 
simplifications  compatible  with  the  main  goals  of  the  R&TTE  Directive.  Option  B3  also 
allows  to  adapt  the  legal  basis  to  some  specific  technologies,  and  to  set  out  a  scope  more 
consistent with the objective of preventing harmful interference. A full implementation of this 
option  B3  requires  complementary  instruments  (outside  the  R&TTE  Directive)  to  improve 
information to manufacturers on national spectrum regulation, to foster efficiency of receivers 
in  the  use  of  spectrum  and  possibly  to  address  competition  issues  raised  by  terminals. 
Commission  delegated  and  implementing  powers  in  this  option  add  the  benefit  of  a  timely 
legal response to technology and market developments and to issues of consistent application, 
also further contributing to improve compliance. 

Option C1 provides an incremental reduction of regulatory barriers to innovation, as well as 
efficiency  gains  within  the  current  framework.  Option  C2  would  provide  more  important 
gains in time-to-market but would also bring uncertainties for investment and additional cost 
for authorities 

Preferred 
option 

A4 

B3 

C1 

Table 9. Preferred options 

Strengths/advantages 

Drawbacks/costs 

Flexible and proportional approach to 
improve  compliance:  to  perform  the 
if 
alignment  with 
necessary 
it  with 
to  complement 
product  registration  in  some  specific 
product categories where a high level 
of compliance has not been attained  

the  NLF,  and 

Possible 
product 
additional 
registration is perceived by industry 
as  additional  burden,  not  foreseen 
within NLF obligations 

implementation 

Direct 
and 
maintenance  cost  of  registration 
system  estimated  at  maximum 
300k€ and 30k€ respectively 

clarification 

Provides 
and 
simplification of legal provisions, and 
future-proof  adaptation  of  scope  and 
requirements in line with the goals of 
a  more  focussed  Directive  covering 
all intentional radio transmitters 

Non-significant  additional  cost  for 
intentional 
non-communicating 
radiators,  which  would  enter  within 
the  scope  of  the  Directive  (up  to  a 
maximum of a fraction of a Euro per 
product in common cases) 

Some  reduction  of  burden  and  cost 
for pure receivers and fixed terminals, 
which  move  out  of  the  scope  of 
Directive 

Improves  access  by  companies  to 
regulators and coordination within the 
current  regulatory  system  for  radio 
equipment  

Does  not  fundamentally  streamline 
the  currently  existing  complex 
regulatory system 

Overall,  this  package  of  preferred  options  is  expected  to  increase  compliance  and  therefore 
improve  protection  of  users  and  of  fair  competition,  to  bring  increased  legal  certainty,  a 
smoother  and  more  consistent  application  of  the  Directive  and  a  more  comprehensive 

EN 

41 

   EN 

 
 
prevention  of  harmful  interference,  with  limited  additional  burden  for  market  operators. 
Beyond the synergies between Options A4 and B3 explained in chapter 7 no other interaction 
effects  are  expected  between  the  three  preferred  options.  Therefore,  an  additional  in-depth 
assessment of the package is not considered necessary. 

At the end of the impact assessment, there was no indication that the selected options might 
result in a disproportionate burden for SME. Consequently, there is no element showing the 
need  for  SME  specific  measures  in  order  to  ensure  compliance  with  the  proportionality 
principle 

9. 

IMPLEMENTATION, MONITORING AND EVALUATION  

9.1. 

Transposition and implementation 

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. 

9.2. 

Reporting and review 

The  table  below  summarises  the  core  indicators  of  progress  towards  meeting  the  objectives 
for the revision of the Directive. 

Table 10. Core indicators of progress 

Indicator 

Approach 

Compliance 

Administrative  and  technical 
compliance ratios 

Periodic  reports  from  Member 
States 

Administrative 
simplification 
legal adaptations 

and 

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

Regular 
stakeholders 
operators, 
notified bodies 

exchange 
- 

authorities 

with 
economic 
and 

Regulatory  barriers  to 
innovation 

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  in  the  Directive.  This  obligation  would  consolidate 
common practice and should not increase administrative costs. 

Further information is to be collected through regular exchanges within TCAM, the standing 
committee of 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. 

EN 

42 

   EN 

 
 
ANNEX I. LIST OF ACRONYMS AND GLOSSARY 

List of acronyms: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

ADCO R&TTE: 

Administrative Co-operation group in the R&TTE area 

CEPT:  European  Conference 
Administrations 

DoC :  Declaration of Conformity  

of 

Postal 

and  Telecommunications 

EFIS:  European Communications Office Frequency Information System 

EMC:  Electromagnetic Compatibility 

EMCD: 
2004/108/EC 

Electromagnetic 

Compatibility 

Directive, 

Directive 

GPSD: General Product Safety Directive, Directive 2001/95/EC 

ISM: 

industrial, scientific and medical  

ITU: 

International Telecommunications Union 

LVD:  Low Voltage Directive, Directive 2006/95/EC 

–  MSA:  Market Surveillance Authority 

– 

– 

– 

– 

– 

– 

– 

NB:  Notified Body 

OSN:  One Stop Notification 

PMR:  Private Mobile Radio 

RSD:  Radio Spectrum Decision, Decision 676/2002/EC  

R&TTE : 

Radio and telecommunications terminal equipment 

SDR:  Software Defined Radio 

TCAM : 
Surveillance Committee 

Telecommunications  Conformity  Assessment  and  Market 

Glossary: 

Some definitions from the R&TTE Directive: 

– 

harmful  interference:  interference  which  endangers  the  functioning  of  a 
radionavigation service or of other safety services or which otherwise seriously 
degrades,  obstructs  or  repeatedly  interrupts  a  radiocommunications  service 
operating in accordance with the applicable Community or national regulations 

– 

interface: can mean  

EN 

43 

   EN 

 
(a) 

a  network  termination  point,  which  is  a  physical  connection  point  at 
which  a  user  is  provided  with  access  to  public  telecommunications 
network, and/or 

(b) 

an air interface specifying the radio path between radio equipment 

– 

– 

– 

radio  equipment:  a  product,  or  relevant  component  thereof,  capable  of 
communication  by  means  of  the  emission  and/or  reception  of  radio  waves 
utilising the spectrum allocated to terrestrial/space radiocommunication 

radio waves: electromagnetic waves of frequencies from 9 kHz to 3000 GHz, 
propagated in space without artificial guide 

telecommunications terminal equipment: a product enabling communication 
or a relevant component thereof which is intended to be connected directly or 
indirectly by any means whatsoever to interfaces of public telecommunications 
networks  (that  is  to  say,  telecommunications  networks  used  wholly  or  partly 
for the provision of publicly available telecommunications services) 

Some definitions from ITU Radio Regulations 2008: 

– 

– 

– 

– 

broadcasting  service:  a 
the 
transmissions  are  intended  for  direct  reception  by  the  general  public.  This 
service  may  include  sound  transmissions,  television  transmissions  or  other 
types of transmission 

radiocommunication  service 

in  which 

industrial,  scientific  and  medical  (ISM)  applications  (of  radio  frequency 
energy):  operation  of  equipment  or  appliances  designed  to  generate  and  use 
locally  radio  frequency  energy  for  industrial,  scientific,  medical,  domestic  or 
similar purposes, excluding applications in the field of telecommunications 

radiodetermination:  the  determination  of  the  position,  velocity  and/or  other 
characteristics  of  an  object,  or  the  obtaining  of  information  relating  to  these 
parameters, by means of the propagation properties of radio waves 

telecommunication: any transmission, emission or reception of signs, signals, 
writings,  images  and  sounds  or  intelligence  of  any  nature  by  wire,  radio, 
optical or other electromagnetic systems  

EN 

44 

   EN 

 
ANNEX II. PRODUCT SCOPE OF THE R&TTE DIRECTIVE 

The  following  codes  and  categories  under  NACE/Prodcom  classification  contain  most 
products falling within the scope of the Directive: 

Table A2.1 Product scope of the R&TTE Directive 

26.20.18.00  

26.30.11.00  

26.30.12.00  

Machines  capable  of  facsimile  transmission,  capable  of  connecting 
to an automatic data processing machine or to a network  

Transmission  apparatus  for  radio-broadcasting  and  television,  with 
reception apparatus  

Transmission  apparatus  for  radio-broadcasting  and 
without reception apparatus  

television, 

26.30.21.00  

Line telephone sets with cordless handsets  

26.30.22.00  

Telephones for cellular networks or for other wireless networks  

26.30.23.10  

Base stations  

26.30.23.20  

26.30.23.30  

26.30.23.70  

transmission  or 
the  reception,  conversion  and 
Machines  for 
regeneration of voice, images or other data, including switching and 
routing apparatus  

Telephone sets (excluding line telephone sets with cordless handsets 
and telephones for cellular networks or for other wireless networks); 
videophones 

Other apparatus for the transmission or reception of voice, images or 
other  data,  including  apparatus  for  communication  in  a  wired  or 
wireless network (such as a local or wide area network), other than 
transmission  or  reception  apparatus  of  HS  84.43,  85.25,  85.27  or 
85.28 

26.30.30.00  

Parts of electrical telephonic or telegraphic apparatus  

26.30.40.40  

Aerials and aerial reflectors of all kinds for apparatus of HS 85.17; 
parts suitable for use therewith  

EN 

45 

   EN 

 
ANNEX III. BASIC ECONOMIC DATA OF THE EU MARKET COVERED BY THE 
DIRECTIVE 

Some basic data of the EU economic sector manufacturing products falling within the scope 
of  the  R&TTE  Directive  are  shown  below.  Unless  otherwise  stated,  the  data  have  been 
obtained from Eurostat63 in accordance with Annex II above. 

Table A3.1 . EU production, consumption and trade. Values in million €

EU27 production 

EU27 imports 

EU27 exports 

EU27 internal 
consumption 

2007 

2008 

2009 
(estimation) 

54290 

48696 

40294 

62692 

52052 

49216 

40138 

61130 

43131 

47781 

39260 

51652 

Some  75%  of  EU  production  is  exported,  and  80%  of  EU  consumption  is  imported.  This 
means that ca 80% of equipment placed on the EU market is manufactured abroad. 

Trade  balance  is  negative  and  the  trade  deficit  (-8402  million  €)  am ounts  to  ca  15%  of 
production. The main trading partners are US and Asia (China, Korea, Japan). Trade deficit 
with  China  (-12905  million  €)   offsets  a  positive  trade  balance  with  the  rest  of  the  world 
(+4503 million €). Imports are more geogra phically concentrated than exports. 

Table A3.2 . EU trade with selected countries in 2007. Values in million €

China 

Japan 

South Korea 

US 

Imports  Exports Balance 

14590 

2375 

5817 

13903 

1685 

1330 

581 

8558 

-12905 

-1045 

-5236 

-5345 

The number of people employed in manufacturing companies is about 250000 employees 

Table A3.3. Number of employees in the EU 

Number of employees 

293900 

257,400 

2004 

2007 

As in other EU industrial sectors, most companies (99%) belong in the SME category.  

Table A3.4. Size of companies 

63 

http://epp.eurostat.ec.europa.eu 

EN 

46 

   EN 

 
 
  
 
 
 
                                                 
Number of 
employees/company

of 

Number 
companies 
(percentage) - 2007 

EU 

> 250 

50 - 250 

1 - 50 

Total 

120 (0.87 %) 

385 (2.90 %) 

13,270 (96.33 %) 

13775 (100%) 

Larger companies concentrate up to 76% of total production, on the basis of statistics from 6 
countries accounting for 89% of EU production: 

Country 

Table A3.5. Size of companies 

Share  of  production 
by  companies  >250 
employees64 

Germany 

Finland 

France 

Italy 

Sweden 

UK 

Total for 6 countries 

88% 

94% 

78% 

50% 

93% 

76,2 

76% 

Estimations  of  the  number  of  different  products  subject  to  the  R&TTE  Directive  which  are 
available in the market range between 3000 and 10000 products. 

Table A3.6  Total market size for products falling within the scope of the R&TTE 
Directive Source: Technopolis survey 

Market 
Authority 

Surveillance 

Estimated  market  size  (2008)  in  terms  of 
number  of  product  types  on  the  market 
subject to R&TTE Directive 

64 

Data correspond to products within NACE Code 332 - Manufacture of television and radio transmitters 
and apparatus for line telephony and line telegraphy  

EN 

47 

   EN 

 
 
                                                 
Market 
Authority 

Surveillance 

Estimated  market  size  (2008)  in  terms  of 
number  of  product  types  on  the  market 
subject to R&TTE Directive 

MSA 01 

MSA 02 

MSA 03 

MSA 04 

MSA 05 

3,000 

4,000 

5,200 

7,000 

10,000 

Average of estimations  5,840 

EN 

48 

   EN 

 
ANNEX IV. SUMMARY OF THE 2007 PUBLIC CONSULTATION 

A  public  consultation  took  place  in  2007,  allowing  to  identify  the  main  problems  in  the 
operation of the Directive as well as the possible remedies. The consultation used the “IPM” 
(Interactive Policy Making)65 tool and was closed on 30 September 2007.  

Some 120 questions addressed the following topics: 

• 

• 

• 

• 

• 

• 

• 

A regulatory framework conducive to investment and product innovation 

Simplification 

Compliance 

Standard-setting 

Scope of the Directive 

Software-defined radio 

Optimisation  of  the  running  of  the  directive  and  coherence  with  other  community 
legislation 

Responses  were  contributed  by  60  respondents  from  the  categories  of  large  company  (17), 
SME (7), regulators (15), notified bodies (4) and others. 

Some of the issues highlighted were: 

• 

• 

• 

• 

• 

• 

• 

Difficulties in market entrance for innovative radio technologies due to the existing 
process for putting in place the necessary regulatory decisions concerning spectrum 
use and harmonised standards 

The Directive is unnecessaritly complex and its application is confronted to a number 
of ambiguous provisions 

Some stakeholders expressed the wish that, for some details of the operation of the 
Directive, TCAM conclusions be binding on all Member States. 

There  are  eighteen  administrative  provisions  in  the  Directive  and  the  relevance  of 
some of them was questioned 

Lack  of  traceability  of  the  manufacturer  or  the  person  responsible  for  placing 
products on the market needed to be addressed 

Very  few  cases  in  which  presumption  of  conformity  conferred  by  harmonised 
questions was questioned 

Particularly  challenging  appeared  to  be  the  case  of  equipment  reconfigured  during 
operations  by  users  and/or  an  entity  other  than  the  initial  manufacturer,  such  as 
‘Software Defined Radio’ (SDR), or cognitive radio 

65 

HTTP://EC.EUROPA.EU/YOURVOICE/IPM/ 

EN 

49 

   EN 

 
                                                 
• 

• 

• 

One  third  of  respondents  considered  that  installations  where  not  sufficiently 
addressed in the Directive, half of respondents considered this was not an issue 

In practice most NB opinions concerned products which use harmonised standards to 
ensure  compliance  with  the  essential  requirements  of  the  Directive,  but  for  which 
manufacturers - due to the often high technical complexity of conformity assessment 
- preferred to seek an endorsement from an experienced and qualified body 

Some  arbitrary  demarcations  of  scope,  e.g.  broadcast  receivers,  lacked  a  real 
justification 

Issues identified through this consultation were included in the Second Progress Report on the 
operation of the R&TTE Directive (see ref. [2]).  

EN 

50 

   EN 

 
ANNEX V. LIST OF INTERVIEW PARTNERS FOR THE TECHNOPOLIS STUDY 

‘Impact Assessment concerning a proposed mandatory registration system in the scope 
of directive 1999/5/EC’ FINAL REPORT 5.10.2009. Technopolis Group66. (ref. [8]) 

Table 1. List of interview partners  

Nr. 

(Primary) 
partner 

interview 

Organisation 

Country 

Market surveillance authorities 

Edmund Palkovich et al. 

Stefan Winkelmann et al. 

Federal Ministry of Transport, 
Innovation and Technology 

Austria 

Bundesnetzagentur (BNetzA), German 
federal Network Agency 

Germany 

Per G Andersson 

Swedish Post and Telecom Agency 

Sweden 

Loredana Le Rose 

Department of Communications, 
Ministry of Economic Development 

CliveCorrie et al. 

Ofcom 

Italy 

UK 

Maria Sarantopoulou 

National Telecommunications and Post 
Committee (EETT) 

Greece 

Hakim LaTrache et al. 

Agence Nationale de Fréquences 

France 

Bert van Dijk 

Tanel Vinkel 

Kati Heikkinen 

Lucio Cocciantelli 

Albinas Visockas 

Tor Bringsverd 

Netherlands Radiocommunications 
Agency  

Estonian Technical Surveillance 
Authority 

Finnish Communications Regulatory 
Authority 

The Netherlands 

Estonia 

Finland 

OFCOM/BAKOM – Federal Office of 
Communication 

Switzerland 

Communications Regulatory Authority 
(RRT) 

Lithuania 

Norwegian Post and 
Telecommunications Authority 

Pedro Martins 

ICP-ANACOM 

Companies 

Matt Hansson/Jose Prats 

Sony Ericsson 

Mr Esa Barck 

Nokia Siemens Networks  

Norway 

Portugal 

Sweden 

Finland 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

1 

2 

66 

http://ec.europa.eu/enterprise/sectors/rtte/files/technop-ia-radio-finrep_en.pdf 

EN 

51 

   EN 

 
 
 
 
                                                 
Ms Marita Latovehmas 

Satel OY *) 

Mr Stewart Polley 

Nokia oyj 

Ms Kristine Kiltgaard 
Pedersen 

Oticon *) 

Gerhard Doujak 

Emporia GSM *) 

Ken Simpson 

Belkin Ltd (UK) 

Stylianos Tsatalas et al. 

INTRACOM TELECOM 

Finland 

Finland 

Denmark 

Austria 

UK 

Greece 

Armin Schoeller/Paul 
Guckian 

QUALCOMM 

Germany/US 

3 

4 

5 

6 

7 

8 

9 

10 

Dimitrios Scribas  

Marac Electronics 

11  Mario Protopappas 

PARISINO *) 

12 

13 

14 

15 

16 

17 

18 

19 

20 

Sergio Pastori 

Alcatel-Lucent 

Alessandro Tacchini 

Reggio Emilia 
Innovazione/Laboratorio Nobili 

Francesco Segato 

Duolabs 

Andrew Little 

Raymarine 

Steven Clegg 

Mira 

Iain King 

Link Research *) 

Edgar Vangeel 

CISCO Systems 

Tim Cull 

Motorola Ltd. 

Stuart Graves 

SAMSUNG 

21  Marion Rühle 

ELDAT GmbH *) 

22 

23 

24 

25 

Erwin Schmidt 

Pepperl & Fuchs GmbH 

Antoine Fruhauf 

VEGA Grieshuber 

Andre Malitte 

SHARP 

Per Döfnäs 

Ericsson 

26  Mats Lindkvist 

Ondico *) 

Greece 

Greece 

Italy 

Italy 

Italy 

UK 

UK 

UK 

Belgium 

United 
Kingdom 

UK/Korea 

GER 

GER 

GER 

GER/Japan 

Sweden 

Sweden 

27 

28 

EN 

Nils-Åke Rosenberg 

Swedish Radio Systems AB *) 

Sweden 

Ian van Zyl 

Siemens Milltronics 

GER/Canada 

52 

   EN 

 
Industry associations and other 

1 

2 

3 

4 

5 

6 

7 

George Tannahill 

Federal Communications Commission 

Tony Graziano 

DIGITALEUROPE 

Stefan Herzog 

BITKOM 

Alexandra Schleier 

ZVEI 

Joshua Rosenberg 

ITIC - Information Technology 
Industry Council  

Feodora von Franz 

TechAmerica Europe 

Marc Cumps 

AGORIA 

FCC (USA) 
representative 

Europe  

Germany 

Germany 

United States 
(International) 

United States 
(International) 

Belgium 

*) Firm is an SME according to EU definition. 

EN 

53 

   EN 

 
 
ANNEX VI. SUMMARY OF THE 2010 PUBLIC CONSULTATION 

0. Introduction  

As part of the preparation of the review of the R&TTE Directive67, the Commission collected 
information  in  an  extensive  public  consultation  in  2007,  in  the  2009  Technopolis  study 
"Impact  assessment  study  on  the  option  of  a  mandatory  registration  for  placing  radio 
equipment on the market which could be introduced in Directive 1995/5/EC68" and within the 
standing  committee  of  the  Directive  (TCAM).  The  Commission  launched  a  second  public 
consultation in 2010 in order to collect additional information on the impact of some of the 
measures  under  consideration  for  the  revision  of  the  Directive  and  also  to  reach  out  to 
stakeholders who may not have been able to express their views on the issues and measures 
under consideration. This annex presents an overview of the responses obtained. 

The questionnaire was online between 16.07.2010 and 15.09.2010 and included 20 questions 
relative to the following issues: 

• 

• 

• 

• 

Compliance with the Directive 

Clarification of the Directive and reduction of administrative obligations 

Scope of the Directive in relation to specific legislation 

Other issues: accessibility of R&TTE products 

A  simplified  version  of  the  questionnaire  was  also  available  for  SMEs  and  was  distributed 
through the Commission SME Network, which resulted in the high level  of participation of 
this category. 

This  document  summarises  some  elements  of  the  responses  received.  For  the  statistical 
analysis of the responses, please refer to Annex I in ref [12]. 

1. Identification and characterisation of the respondents 

There was an important participation in this public consultation as the Commission received 
122  replies  with  a  significant  contribution  from  economic  operators  (36  companies  +  50 
SMEs).  

Participation of public authorities was more limited, owing to the fact that public authorities 
have  other  means  to  convey  their  views  on  the  legislative  review  to  the  Commission,  in 
particular through their participation in TCAM (4 meetings in 2010).  

2. Compliance with the Directive  

Respondents expected from the NLF alignment a medium to strong impact on compliance 
with  the  Directive  (71%  in  the  categories  ‘some  impact’  or  ‘significant  impact’  in  general 

67 
68 

Radio and Telecommunications Terminal Equipment, Directive 1999/5/EC OJ L 91, 7.4.1999, p. 10–28 
http://ec.europa.eu/enterprise/sectors/rtte/files/technop-ia-radio-finrep_en.pdf 

EN 

54 

   EN 

 
 
                                                 
comparing  to  72%  for  SMEs).  The  measure  is  considered  to  entail  a  moderate  increase  of 
burden. 

Respondents  highlighted  that  the  newly  introduced  provisions  of  the  NLF  especially 
obligations  for  importers  and  distributors,  together  with  the  introduction  of  traceability 
requirements will introduce a positive impact on surveillance activities and will consequently 
produce  a  significant  improvement  of  compliance  with  the  R&TTE  Directive.  It  will  also 
contribute to create a fair market environment for all economic operators. 

Industry  mentioned  that  the  positive  impact  will  depend  on  whether  the  NLF  will  be 
uniformly applied to all relevant Directives. 

Some negative effects on administrative burden of the NLF alignment mentioned were the 
new  requirements  on  traceability  information,  the  possibility  to  ban  compliant  products 
presenting  a  risk  to  health  and  safety  or  the  translation  of  the  DoC  and  the  technical 
documentation. 

Concerning  a  possible  mandatory  product  registration  under  the  Directive,  it  was  also 
expected that this system would have a medium to strong impact on compliance (65% in the 
categories ‘some impact’ or ‘significant impact’ in general comparing to 66% for SMEs) but 
entailing  a  strong  increase  of  burden  (66%  in  the  categories  ‘some  increase'  or  ‘significant 
increase  of  administrative  burden'  in  general  comparing  to  62%  for  SMEs).  It  is  to  be 
highlighted that on 12% of SMEs anticipate a ‘significant increase’ the overall value is 32%.  

Some  respondents  mentioned  that  the  obligation  of  a  registration  would  allow  Market 
Surveillance  Authorities  to  easily  comply  with  their  new  tasks  under  the  NLF  but  some 
manufacturers were sceptical with regard to the possibilities of registration to counter criminal 
behaviour. 

It was also said that a registration scheme would just add additional administrative burden by 
collating,  uploading  and  updating  product  information  without  solving  the  original  concern 
identified  traceability  and  compliance  since  it  does  not  prevent  deliberate  false  registration. 
The  issue  of  confidentiality  of  information  uploaded  in  the  registration  database  was  also 
pointed out. Furthermore a registration scheme under the R&TTE Directive will only address 
one  Directive  while  the  NLF  takes  a  more  horizontal  and  harmonized  approach  and  this 
would be critical for products falling under the scope of several Directives. 

Respondents also highlighted  that  resources  for  market  surveillance  are  an  important  key  in 
order to achieve a higher compliance with the Directive. 

3. Clarification of the Directive and reduction of administrative obligations 

There was a moderately positive perception of the impact on clarity of the inclusion of all 
radio receivers within the scope of the Directive. The perception was slightly more positive 
among  SMEs  (60%  in  the  categories  'some  clarification'  or  'significant  clarification')  than 
among  respondents  in  general  (48%).  It  was  highlighted  by  several  respondents  that  the 
Commission  should  consider  carefully  consequences  for  broadcast  receivers  if  this  option 
should be applied.  

The definition of performance requirements for radio reception was considered beneficial 
for  the  efficiency  in  the  use  of  spectrum  by  many  stakeholders,  in  particular  by  network 
operators  and  spectrum  authorities.  Industry  in  general  did  not  consider  that  changing  the 

EN 

55 

   EN 

 
scope of the Directive would bring any positive impact but only additional administrative and 
technical  burden  to  manufacturers,  which  does  not  seem  to  be  justified  comparing  to  the 
limited  potential  added  value.  Industry  also  pointed  out  that  during  the  last  15  years  the 
application of the EMCD and LVD for audio and TV broadcast receivers has been proven to 
be  sufficient  and  appropriate  as  no  problems  have  been  reported.  For  cases  where  the 
performance of receivers might have an impact on the performance of transmitters, industry 
proposed  the  development  of  appropriate  Harmonised  Standards  and  compatibility  studies 
which will be more appropriate as a modification of the essential requirements.  

Regarding the possibility to exclude indirectly connected terminal equipment, the impact 
on  clarity  is  moderately  positive.  For  greater  clarity,  it  was  proposed  that  the  Commission 
should consider removing fixed terminals from the scope of the Directive as a way to avoid 
having similar equipment under the R&TTE Directive and under the LVD and EMCD. 

On  the  option  to  include  the  definitions  of  fixed  and  mobile  installations  and  clarify  the 
application  of  the  R&TTE  Directive  to  both  cases  there  was  a  general  moderately  positive 
impact  (48%  in  the  categories  'some  clarification'  or  'significant  clarification'  in  general 
comparing to 50% for SMEs). Several comments pointed to the difficulty to apply EU level 
legislation  to  the  many  specific  cases  which  could  be  considered  to  be  installations,  to  the 
difficulties of defining installations, and to overlaps with national legislation. 

The possibility to incorporate agreements and clarifications agreed in TCAM and collected 
in  the  Guide  in  the  revised  Directive  was  welcomed  in  a  very  positive  way  (66%  in  the 
categories  'some  clarification'  or  'significant  clarification'  in  general  comparing  to  52%  for 
SMEs) as the Guide has been very useful for economic operators. 

A positive impact on the reduction of administrative burden is also to be noted by the possible 
suppression of notifications under Article 6.4: 43 % of respondents consider a suppression 
of this requirement to bring in some or significant reduction of burden 

There was a strong reservation on the suppression  of Article 4.2 which obliges operators to 
publish  technical  specifications  of  public  interfaces  prior  to  provision  of  services,  due  to 
competition  issues.  It  was  mentioned  that  this  obligation  for  operators  should  be  mirrored 
with  an  obligation  for  terminal  manufacturers,  in  particular  with  regard  to  creating  a  level 
playing  field  for  software  applications  for  terminals,  and  with  regard  to  access  to  contents 
from terminals.  

Finally the option to suppress the obligation to affix the "Alert Sign" on radio equipment 
for which Member States apply restrictions on the putting into service had a moderate positive 
impact  in  the  reduction  of  burden  (31%  in  the  categories  'some  reduction'  or  'significant 
reduction  of  administrative  burden'  in  general,  28%  for  SMEs).  A  number  of  respondents 
insisted that it is very important to alert user on restrictions to use of radio equipment. 

Some  respondents  also  referred  to  the  necessity  to  revise  the  proportionality  of  current 
obligations for operators in Article 7.5 of the Directive in case of a situation of emergency. 

4. Scope of the Directive in relation to specific legislation 

The possible positive impact on simplification of excluding from the scope of the Directive 
radio  equipment  covered  by  other  more  specific  EU  legislations  or  by  international  treaties 
(e.g. equipment for Air Traffic Management or radars for inland waterways) was considered 
as non-significant by more than half of respondents in the 2010 public consultation (30% no 

EN 

56 

   EN 

 
simplification,  16  %  no  simplification).  This  view  is  even  clearer  among  SME  (52%  no 
simplification, 28 % no simplification). 

Some of the responses pointed to the stability of the current legal framework for equipment 
for Air Traffic Management and to the importance of managing all equipment liable to create 
harmful interference under the R&TTE Directive  

5. Other issues 

Regarding the accessibility of equipments for users with a disability, the general opinion was 
that there was no need to amend Article 3.3f of the Directive. Some associations mentioned 
the  need  to  implement  this  Article  with  the  enactment  of  relevant  Commission  Decisions, 
others were of the opinion that the R&TTE Directive was not the good legal instrument for 
this  issue  and  that  the  Universal  Service  Directive  was  a  more  appropriate  horizontal 
instrument to deal with this. 

EN 

57 

   EN 

 
ANNEX VII. ADDITIONAL ITEMS AFFECTING THE AMBIGUITY AND 
COMPLEXITY OF THE DIRECTIVE 

-Notifications of national technical regulations covering R&TTE equipment under Article 
4.1 of the Directive coincide with similar obligations under Directive 98/34. 

-Notification  by  operators  to  national  authorities  of  the  technical  characteristics  of  their 
public  interfaces  under  Article  4.2  coincide  with  a  similar  obligation  under  Directive 
2008/63/EC on competition in the markets in telecommunications terminal equipment. 

-The  Directive  includes  a  number  of  provisions  fostering  the  emergence  of  a  competitive 
market  for  terminals  (article  4.2  on  publication  of  interfaces  by  operators,  article  6.3  on 
information  to  the  user  on  available  interfaces,  articles  7.3-7.5  on  the  right  to  connect  a 
terminal  to  a  network).  These  obligations  were  included  to  avoid  that  operators  unilaterally 
determine the specifications of terminals compatible with their networks, which would enable 
them to transfer its market power in the area of services to the market for terminals. However, 
the  Directive  does  not  contain  provisions  to  prevent  possible  distortions  of  competition 
created  by  manufacturers  of  terminals  on  electronic  communications  markets  such  as  the 
following: 

•  In  the  mobile  market,  closed  on-line  application  stores  linked  to  an  operating 
system  or  a  particular  terminal,  which  bind  the  consumer  to  the  choice  of 
application, contents and/or network operator of his/her device manufacturer; 

•  In  the  TV  market,  the  presence  within  TV  receivers  of  closed  browsers  with 

technical characteristics which condition access to particular contents 

EN 

58 

   EN 

 
ANNEX VIII. LEGISLATION AFFECTING THE PUTTING INTO SERVICE OF 
RADIO EQUIPMENT 

Equipment complying with the requirements in the R&TTE Directive can be put into service 
in the EU (article 7.1 of the Directive). However, article 7.2 of the Directive allows Member 
States  to  introduce  further  restrictions  in  order  to  ensure  and  effective  use  of  the  spectrum, 
avoid harmful interference or protect public health.  

Conditions  for  the  use  of  spectrum  are  only  partially harmonised across the EU. In practice 
regulation  of  radio  spectrum  is  largely  a  national  competence.  Member  States  publish 
national frequency plans, ‘radio interfaces’ which are technical conditions laid out in national 
regulations, and other conditions for use of the spectrum such as individual licences or general 
authorisations.  When  exercising  this  competence,  Member  States  shall  comply  with 
applicable EU law, in particular: 

•  General  criteria  laid  down  in  the  Directive  2002/21/EC  (Framework  Directive69)  within 

the regulatory framework for electronic communications 

•  Conditions for authorisations for the use of spectrum laid down in Directive 2002/20/EC 
electronic 
the 

framework 

regulatory 

for 

(Authorisation  Directive70)  within 
communications 

•  More  specific  are  the  implementing  measures  under  Decision  676/2002/EC  (Radio 
Spectrum Decision71). Such measures harmonise in detail the technical conditions for the 
use of certain spectrum bands in the EU, and are binding to all Member States. Examples 
of  bands  harmonised  at  EU  level  include  the  bands  for  GSM,  UMTS  and  short-range 
devices. 

EU  Member  States  cooperate 
(European  Conference  of  Postal  and 
Telecommunications Administrations) with other countries in the European area in the use of 
spectrum,  including  in  some  cases  its  harmonisation.  CEPT  is  an  intergovernmental 
organisation  which  makes  recommendations  and  non-directly  binding  decisions,  the 
implementation of which depends on legal acts by its member states.  

in  CEPT 

Finally,  EU  Member  States  are  members  of  the  International  Telecommunications  Union 
(ITU),  which  develops  the  Radio  Regulations  setting  a  frame  to  regional  and  national 
regulations on the use of spectrum, and which ITU member states commit to abide by. 

69 

70 

71 

EN 

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), OJ 
L 108, 24.4.2002, p. 33–50  
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), OJ L 108, 
24.4.2002, p. 21–32  
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), OJ L 108, 24.4.2002, p. 1–6  

59 

   EN 

 
                                                 
ANNEX IX. DETAILED DESCRIPTION OF OPTION A1 

Under Option A1, the R&TTE Directive would take on board the solutions set out in the NLF 
Decision  768/2008  to  address  problems  relating  to  non-compliance.  The  measures  in  the 
Decision designed to resolve these problems are as follows: 

• 

• 

• 

• 

Introduction  of  obligations  for  importers  and  distributors:  Both  must  check  that 
products bear the CE marking, are accompanied by the required documents and carry 
the  name  of  the  manufacturer  and  the  importer  (if  relevant).  Importers  must 
furthermore  check  that  the  manufacturer  outside  the  EU  has  applied  the  correct 
conformity assessment procedure and establish a link to the manufacturer that allows 
the technical documentation to be obtained when it is requested by authorities. They 
must  carry  out  sample  tests  on  products  which  they  have  supplied,  when  this  is 
appropriate in the light of the risks presented by a product to the health and safety of 
consumers.  If  necessary,  they  must  also  keep  a  register  of  complaints,  non-
conforming products and product recalls and keep distributors informed about such 
monitoring (Articles R4 and R5 in Annex 1 of Decision 768/2008). 

Additional manufacturer obligations: In addition to the obligations that the current 
legislation  already  imposes  on  manufacturers,  they  must  provide  instructions  and 
safety  information  in  a  language  easily  understood  by  consumers  and  end-users. 
Furthermore, they are subject to the same obligations on sample testing and product 
monitoring as importers (Article R3 in Annex 1 of Decision 768/2008). 

Introduction  of  traceability  requirements:  New  obligations  are  introduced  for  all 
economic  operators  to  ensure  traceability  of  products  throughout  the  whole 
distribution chain. Manufacturers and importers must put their name and address on 
the  product  or,  where  this  is  not  possible,  on  the  packaging  or  an  accompanying 
document.  Furthermore  every  economic  operator  must  be  able  to  inform  the 
authorities  from  whom  he  purchased  a  product  and  to  whom  he  supplied  it.  This 
obligation  does  not  include  sales  to  end-users  (Article  R7  in  Annex  1  of  Decision 
768/2008). 

Reorganisation  of  safeguard  clause  procedure  (market  surveillance):  The  safeguard 
clause procedure has been reorganised and streamlined. The new procedure ensures 
that the relevant enforcement authorities are informed about dangerous products and 
that similar action is taken against that product in all Member States (Articles R31-33 
in Annex 1 of Decision 768/2008). 

EN 

60 

   EN 

 
 
ANNEX X. ESTIMATION OF THE DIRECT COST OF A PRODUCT 
REGISTRATION SYSTEM 

Some assumptions on the system to be introduced according to Option A3 are the following: 

– 

– 

– 

The  highest  available  estimation  of  the  number  of  product  types  on  the  market 
subject  to  R&TTE  Directive  is  10000  products  (see  in  Annex  III  the  estimation  of 
MSAs). A conservative assumption is that all product are renewed every 2 years 

Compliance  data  to  be  uploaded  in  a  central  database  do  not  need  to  include 
company  sensitive  data,  therefore  no  complex  access  protection  needs  to  be 
implemented 

The Commission services would not perform vetting of the uploaded information in 
order to verify that the submitted files are genuine and valid 

On this basis, a pan-European registration system would have the following characteristics: 

– 

– 

– 

Database  of  circa  5000  types/year  of  maximum  50MB  per  product,  i.e. 
additional 250 GB/year [Source: Commission services]  

A  simple  registration  system  can  be  developed  on  the  basis  of  the  current 
OSN72  system,  of  which  the  investment  cost  was  100000  €  and  maintenance 
cost is below 10000 €/year  [Source: Commission services]  

A  more  powerful  system  including  communications  is  necessary  in  order  to 
allow  for  heavier  and  more  frequent  transactions  and  for  a  user-friendly 
interface  for  the  functions  of  allocation  of  registration  numbers,  upload  of 
product information and consultation.  

Taking  into  account  these  characteristics,  a  conservative  estimate  of  costs  is  [Source: 
Commission services] : 

– 

– 

Estimated investment costs:  300000 €  

Estimated annual maintenance costs: 30000 € 

A  system  limited  to  registration  of  some  categories  of  products  as  in  Option  A4  would  of 
course imply lower costs, the reduction would be less than proportional. 

72 

EN 

One Stop Notification system for notifications according to article 6.4 of the Directive, see section 4.2.4 

61 

   EN 

 
 
                                                 
ANNEX XI. ESTIMATION OF ADDITIONAL COST POR SOME INDIVUAL 
PRODUCTS UNDER OPTION B2 

Possible additional costs stemming from B-options are identified on page 34, in particular for 
those products currently covered by the EMC Directive which would fall within the scope of 
R&TTE D under option B2.  

A possible repercussion of such costs upon individual products considering different scenarios 
is included in the table below: 

Table A10.1 . Range of additional cost per individual product (€) 

Nb of 
products 
sold of a 
certain type 

100 

1000 

10000 

100000 

Additional cost per product type (see page34 – option B2) 

100  

2000  

5000  

(no new test, just re-
formatting of existing 
test) 

(intermediate case) 

(additional radio and 
safety testing plus 
Notified Body 
opinion, no mitigation 
measure) 

1 

0.1 

0.01 

0.001 

20 

2 

0.2 

0.02 

50 

5 

0.5 

0.05 

Sufficient delays for entry into force of the new scope should in practice eliminate the need 
for  manufacturers  to  contract  external  testing  and  to  consult  with  notified  bodies,  leaving 
tests. 
conformity  on 
them 

the  basis  of 

the  option 

to  declare 

in-house 

EN 

62 

   EN 

 
 
 
ANNEX XII.  SME TEST 

(1) 
representatives 

Consultation 

with 

SME 

Interviews  with  SMEs  have  been  carried  out  in 
the  framework  of  the  external  study  done  by 
Technopolis.  

the 

A  specific  consultation  on 
impact  on 
measures under consideration took place through 
the  Enterprise  Europe  Network  in  2010.  50 
SMEs  participated  in  the  exercise.  See  section 
2.3, as well as Annex V.  

Preliminary 

(2) 
businesses likely to be affected 

assessment 

of 

Some  99%  of  EU  manufacturers  in  the  area  of 
products covered by the Directive fall within the 
SME category (see Annex III).  

SMEs contribute some 25% of EU production in 
this area (see Annex III).  

(3) Measurement of the impact on SME  Available  evidence  does  not  show  specificities 
in  the  impact  on  SMEs  of  the  options  under 
consideration.  This  applies  in  particular  to  cost 
and  administrative  burden.  The  exception  is 
option A3 on product registration, for which the 
impact  on  administrative  burden  was  perceived 
as  less  significant  by  SMEs  than  by  larger 
companies. 

(4)  Assess  alternative  options  and 
mitigating measures 

At  the  end  of  the  impact  assessment,  there  was 
no  indication  that  the  selected  option  might 
result  in  a  disproportionate  burden  for  SME. 
Consequently,  there  is  no  element  showing  the 
need  for  SME  specific  measures  in  order  to 
ensure  compliance  with 
the  proportionality 
principle. 

EN 

63 

   EN 

 
 
 
ANNEX XIII. SELECTED REFERENCES 

[1]  Report  from  the  Commission  to  the  Council  and  the  European  Parliament  of  22  April 
2004  –  First  Progress  Report  Directive  1999/5/EC  on  radio  equipment  and 
telecommunications  terminal  equipment  and  the  mutual  recognition  of  their  conformity. 
[COM(2004) 288 final – Not published in the Official Journal]. 

[2]  2nd  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]. 

[3]  Report  to  TCAM  and  ECC  on  R&TTE  Market  Surveillance  Campaign  carried  out  by 
ADCO and RA11 Survey Dates: September 2002 - October 2003. Date: 28 November 2003 

[4]  Report  on  the  second  joint  cross  border  R&TTE  Market  Surveillance  campaign  carried 
out  in  2005/06  by  European  Market  Surveillance  Authorities  Survey  Dates:  1.  September 
2005 – 1. June 2006 Report date: February 2007 final Version 

[5]  Report  on  the  Third  Joint  Cross  Border  R&TTE  Market  Surveillance  Campaign  by  the 
European Market Surveillance Authorities in 2008/2009 Survey Dates: 1. September 2008 – 
31. May 2009 final Version Report date: 8th October 2009 / Rev. 4th November 2009 

[6]  Report  on  the  Fourth  Joint  Cross  Border  R&TTE  Market  Surveillance  Campaign  (low 
power  FM  Transmitter),  by  the  European  Market  Surveillance  Authorities  in  2009.  Survey 
Dates: 15. June 2009 – 02. October 2009. Final Version. Report date: 13th April 2010 

[7] TCAM (30)18 - ADCO-RTTE surveillance statistics for 2009 

[8] 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 

[9]  TCAM  Ad  Hoc  Working  Group  on  Traceability  &  Compliance.  Final  report.  17th  June 
2010 

[10] TCAM Ad-hoc working group Alignment NLF. Final report on alignment of the R&TTE 
Directive with the Decision 768/2008/EC. 1st June 2010 

[11] Final report of the TCAM Ad hoc Working Group on making radio equipment regulation 
more innovation friendly (INNOV WG). 20th October 2010 

[12] 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 

EN 

64 

   EN