Draft RED Guide 22 05 2015

DRAFT RE Guide - Version of 19th March 2015
DRAFT Guide to the RE Directive 2014/53/EU
Version of 22nd May 2015
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Contents
0 Introduction .................................................................................................... 7
1 SCOPE ........................................................................................................... 9
1.1 General ........................................................................................................... 9
1.1.1 Geographic scope ................................................................................... 9
1.1.2 Mutual Recognition Agreements (MRAs) ............................................. 9
1.1.3 What is excluded from the scope of the RED ........................................ 9
1.1.4 Special measures regarding radio equipment at trade fairs, etc. .......... 11
1.1.5 Second-hand radio equipment.............................................................. 11
1.1.6 Radio equipment also covered by other specific legislation ................ 11
1.1.7 Other applicable legislation ................................................................. 11
1.2 Defining “radio equipment” ......................................................................... 11
1.3 Wires ............................................................................................................ 12
1.4 Antennas ...................................................................................................... 12
1.5 Test equipment (transmitting radio frequencies) ......................................... 12
1.6 Jammers ....................................................................................................... 12
1.7 Programmable equipment ............................................................................ 12
1.8 Components/sub-assemblies ........................................................................ 13
1.9 Construction kits .......................................................................................... 13
1.10 Products for own use .................................................................................... 13
1.11 Fixed installations ........................................................................................ 13
1.12 Comparaison R&TTED – RED ................................................................... 14
1.12.1 Changes in the scope ............................................................................ 14
1.12.2 Other changes....................................................................................... 14
1.13 Transitional provisions................................................................................. 14
1.14 General ......................................................................................................... 14
1.15 Products newly covered by RED ................................................................. 14
1.16 Products not any more covered by RED ...................................................... 14
2 Obligations of the economic operators ........................................................ 15
2.1 General ......................................................................................................... 15
2.2 Manufacturer ................................................................................................ 15
2.3 Authorised representative ............................................................................ 16
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2.4 Importer........................................................................................................ 16
2.5 Distributor .................................................................................................... 16
3 ESSENTIAL REQUIREMENTS ................................................................ 16
3.1 General ......................................................................................................... 16
3.2 Essential requirements applicable to all radio equipment............................ 16
3.3 Essential requirements applicable to certain type of radio equipment ........ 17
4 SPECIFIC PROVISIONS ............................................................................ 18
4.1 Software defined radio ................................................................................. 18
4.2 Registration of radio equipment types within some categories ................... 18
5 INTERFACE REGULATIONS & SPECIFICATIONS .............................. 18
5.1 Notification of radio interface specifications ............................................... 18
5.2 Assignment of radio equipment classes ....................................................... 18
5.3 HARMONISED STANDARDS .................................................................. 19
5.4 Introduction .................................................................................................. 19
5.5 Revision of harmonised standards ............... Error! Bookmark not defined.
5.6 CONFORMITY ASSESSMENT PROCEDURES...................................... 20
5.7 Introduction .................................................................................................. 20
5.8 Applicable conformity assessment procedures ............................................ 20
5.8.1 Introduction .......................................................................................... 20
5.8.2 Internal production control (Annex II) ................................................ 20
5.8.3 Internal production control plus specific radio equipment tests (Annex
III) 21
5.8.4 Technical construction file (Annex IV) Error! Bookmark not defined.
5.8.5 Full quality assurance (Annex V) ........................................................ 21
5.8.6 Using the compliance procedures of the LVDError! Bookmark not
defined.
5.9 Testing.......................................................................................................... 21
5.10 Documentation required by the conformity assessment procedures............ 21
5.10.1 Technical documentation ..................................................................... 21
5.10.2 EC Declaration of Conformity ............................................................. 22
5.10.3 Concept of “holding at the disposal of the authorities” ....................... 32
5.11 Marking ........................................................................................................ 22
5.11.1 Complete CE marking.......................................................................... 23
5.11.2 CE mark ............................................................................................... 23
5.11.3 Identification number of the notified body .......................................... 23
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5.11.4 Other markings..................................................................................... 23

5.11.5 Marking of radio equipment containing an R&TTE component ......... 24
6 ADMINISTRATIVE REQUIREMENTS ................................................... 24
6.1 Introduction .................................................................................................. 24
6.2 Information for the user ............................................................................... 24
7 NOTIFIED BODIES .................................................................................... 24
7.1 Introduction .................................................................................................. 24
7.2 General concept ........................................................................................... 25
7.2.1 Annex III procedure — Examination of technical documentation ...... 26
7.2.2 Annex IV procedure — Conformity based on full quality assurance .. 28
7.3 Subcontracting ............................................................................................. 29
7.4 Information exchange .................................................................................. 29
7.5 Coordination between notified bodies ......................................................... 29
7.6 Complaints regarding the service provided by notified bodies ................... 30
8 Market surveillance and enforcement .......................................................... 31
ANNEX 1 — Organisations and committees involved ............................................... 34
ANNEX 2 — Acronyms and abbreviations................................................................. 37
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Open questions (to be solved somewhere in the RED Guide)
1. On the inclusion of software/firmware version in the User Manual, per the new RED?
a. Do we only have to list the SW/FW affecting the compliance of the Radio? There can
be instances of SW covering a different aspect of the product which may not be
relevant for product compliance and can be hard to track.
b. Can this info be posted online and the user guide point to the online location? Typically,
user guides are printed weeks/ even months before the final SW is ready. It is
impractical to include the most current info with the units that are shipped. A
Compliance flyer is a possibility if this is mandatory to be included with the product. Is
that sufficient?
c. How do we handle updates to SW/FW (assuming these changes affect the Radio
compliance)? Is online info acceptable?
2. Do we write the maximum output of each band? (e.g. a.) or the entire only one
maximum output? (e.g. b.)
a. Frequency bands Maximum radio-frequency power
2,400-2,483.5 MHz : 20 mW
5,150-5,250 MHz : 10 mW
b. Frequency bands: 2,400-2,483.5 MHz
5,150-5,250 MHz
Maximum radio-frequency power: 20 mW
3. How should frequency band(s) be indicated according article 10.8 ?

The following information shall also be included in the case of radio equipment
intentionally emitting radio waves:
(a) frequency band(s) in which the radio equipment operates;
(b) maximum radio-frequency power transmitted in the frequency band(s) in which the
radio equipment operates.
For example, [5,150-5,250MHz] or [ W52 ]...
Possible answer :
It is normal to always indicate the Frequency in Hz, kHz, MHz, etc. If the manufacturer
wants to add a code of the band, he is always free to do that.
4. Should the output power be based on the general specs or be given for each individual
product (actual measured power for each individual product)
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Disclaimer
This Guide is intended to serve as a manual for all parties directly or indirectly
affected by the RE Directive 2014/53/EU1. It should assist in the interpretation of the
Directive but cannot take its place; it explains and clarifies some of the most
important issues related to the Directive’s application. The Guide also aims to
disseminate widely the explanations and clarifications reached by consensus among
Member States and other stakeholders.
The Guide is based on the RE Directive and on the “New Legal Framework 2 ”
described in the “Blue Guide 20143” and will not duplicate what is already contained
in the “Blue Guide 2014” This Guide will be reviewed periodically to be kept
updated.
The text of this Guide is publicly available, but is not binding in the sense of a legal
act adopted by the EU. In the event of any inconsistency between the provisions of the
RE Directive and this Guide, the provisions of the RE Directive prevail.
Finally, attention is drawn to the fact that all references to the CE marking and EC
Declaration of Conformity relate to the RE Directive only and that the freedom to
place a radio equipment on the EU single market is only guaranteed when all relevant
legislation is complied with. Reference is therefore made, whenever necessary, to
other directives.
1
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation
of the laws of the Member States relating to the making available on the market of radio equipment and
repealing Directive 1999/5/EC
2
Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down
procedures relating to the application of certain national technical rules to products lawfully marketed in
another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008).
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the
requirements for accreditation and market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008).
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008).
3
The 'Blue Guide' on the implementation of EU product rules 2014
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0 Introduction
The purpose of this document is to give guidance on certain matters and procedures4
pertaining to Directive 2014/53/EU of the European Parliament and of the Council of
16 April 2014 on the harmonisation of the laws of the Member States relating to the
making available on the market of radio equipment and repealing Directive
1999/5/EC (RED).
The main objective of the Directive is to establish a regulatory framework for the
placing on the market, free movement and putting into service of radio equipment in
the territory of the European Union5. In order to achieve that aim, a fully harmonised,
high level of protection is required in the Directive, based on Article 95 (ex Article
100a) of the Treaty establishing the European Community. Article 95 enables
measures to be taken with a view to establishing a single market. By virtue of the
Directive, radio equipment compliant with a single set of requirements can be placed
on the EU market. However, Member States can restrict the putting into service of
radio equipment for reasons to do with the effective and appropriate use of the radio
spectrum, avoidance of harmful interference, or matters relating to public health.
Some radio spectrum is harmonised in the EU; the use of non-harmonised frequency
bands remains a prerogative of Member States. The putting into service of radio
transmitters may be restricted in some Member States.
For the vast majority of radio equipment, compliance is assessed by using the
customary and preferred method of conformity to the relevant European harmonised
standard(s).
The present Guide brings together information previously available in several TCAM
documents and related Commission websites. Nevertheless, readers can still consult
on the CIRCA site a list of interpretations6 accepted by the TCAM. This Guide should
also be read in conjunction with the “Blue Guide 2014”.
4
The European Commission undertakes to maintain this Guide. It is our goal to ensure that the information
provided is both timely and accurate. If errors are brought to our attention, we will try to correct them.
However, the Commission accepts no responsibility or liability whatsoever with regard to the information in
this Guide. The information:
- is of a general nature only and is not intended to address the specific circumstances of any particular
individual or entity;
- is not necessarily comprehensive, complete, accurate or up-to-date;
- sometimes refers to external information over which the Commission departments have no control and
for which the Commission assumes no responsibility;
- does not constitute professional or legal advice.
5
In accordance with the Agreement on the European Economic Area (EEA) (Council and Commission
Decision 94/1/EC of 13 December 1993, OJ L 1, 3.1.1994) the territories of Liechtenstein, Iceland and
Norway have to be considered, for the implementation of Directive 1999/5/EC, in the same light as the
territory of the European Union. When the term “European Union” territory is used in this guide, it therefore
applies likewise to the EEA territory. Directive 1999/5/EC is also applicable in other territories where a
suitable international agreement is in operation (see Section 1.1.1). However, when this Guide quotes from
the current text of the Directive, it reproduces the expression “Community” where it is used in the text.
6
http://circa.europa.eu/Public/irc/enterprise/tcam/library?l=/public_documents/tcam_3_1&vm=detailed&sb=Ti
tle.
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The Guide has been structured in a logical manner suitable for users who need to
ensure that their equipment is in conformity with the RED. It is divided into the
following main sections:
1. Scope: allows manufacturers or others to quickly decide whether their radio
equipment falls within the scope of the RED;
1. Define what is a radio equipment
2. What is not a radio equipment, including exceptions
2. Transitional provisions: temporary chapter to be deleted after end of them,
including the difference between R&TTE and RE (not on NLF);
3. Essential requirements: provides an overview of the mandatory technical
requirements;
4. Interface regulations: regulatory information which Member States must
publish about radio interfaces;
5. Equipment classes: these identify equipment which may or may not be placed
on the market and put into service without restriction;
6. Harmonised standards: these standards give a presumption of conformity
with the essential requirements. Other means are available for cases where
harmonised standards have not been or cannot be applied;
7. Obligations of the economic operators: information about the obligations
related to the various involved economic operators and especially those
specific for the RED;
8. Conformity assessment procedures: information about the options for
conformity assessment of radio equipment;
9. Notified bodies: their role, selection, coordination and the treatment of
complaints;
10. Administrative requirements: explains requirements for user information
and other documentation; EC Declaration of Conformity and CE marking;
11. Market surveillance & enforcement: the activities of the Member States to
ensure that radio equipment is in compliance with the Directive.
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1 SCOPE
1.1 General
The RED applies to all radio equipment (exceptions are listed in Section 1.1.3).
1.1.1 Geographic application
Geographical application of this directive is described in chapter 2.8 (Geographical
application) of the “Blue Guide 2014”.
1.1.2 Mutual Recognition Agreements (MRAs)
The equivalence of RED and third countries legislation is currently recognised in
following MRAs:
- EU – Switzerland (pending equivalence assessment)
- ….
Specific information on MRAs may be found in the chapter 9.2 (Mutual recognition
agreements - MRA) of the “Blue Guide 2014”.
1.1.3 What is excluded from the scope of the RED ?
This section is a non-exhaustive list of equipment’s that do not fall in the scope of the
RED directive. The list provides a guidance on equipment’s on the borderline.
Therefore this section has to be checked carefully by taken into account following
elements:
- Including some devices that may not fall into the scope of the RED as for
example DVB-C receivers.
- It may be clearer if some equipment’s from the explicit list of exclusions may
be moved to a section where they can be identified as non-radio equipment.
- In order to finalize the guide in time critical equipment’s that require an
extended discussion on TCAM or expert group level should be discussed
separately.
- Provide some information about to official way how to get to a clear
agreement on borderline equipment (Link to TCAM and expert groups).
Annex I lists radio equipment that is not covered by the RED.
1.1.3.1 Radio equipment used by radio amateurs
RED excludes following radio equipment used by radio amateurs unless the radio
equipment is available commercially:
- Radio kits for assembly and use by radio amateurs;
- Radio equipment modified by and for the use of radio amateurs;
- Equipment constructed by individual radio amateurs for experimental and
scientific purposes related to amateur radio.
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1.1.3.2 Maritime equipment

Equipment falling within the scope of Council Directive 96/98/EC 7 on marine
equipment is excluded from the scope of the Directive.
1.1.3.3 Airborne equipment
Airborne products, parts and appliances falling within the scope of Article 3 of
Regulation (EC) No 216/2008 of the European Parliament and of the Council.
1.1.3.4 Custom-built evaluation kits
Custom-built evaluation kits destined for professionals to be used solely at research
and development facilities for such purposes.
[better description coming from Commission – RED WORKSHOP 2014
1.1.3.5 Radio equipment exclusively used for activities concerning public
security, defence, State security
According article 1.4 of the RED, the directive does not apply to radio equipment
exclusively used for activities concerning public security, defence, State security,
including the economic well-being of the State in the case of activities pertaining to
State security matters, and the activities of the State in the area of criminal law. So,
for example, military radio equipment used solely by armed forces does not fall under
the directive but if this radio equipment is sold to collectors it cannot be used without
being made compliant with the directive. TETRA systems that are widely used by
public authorities are subject to the directive as they are not exclusively used for the
activities excluded from its scope.
1.1.3.6 Others from current R&TTE Guide
Products, appliances and components within the meaning of Article 2 of Council
Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of
technical requirements and administrative procedures in the field of civil aviation are
excluded. This exclusion relates to on-board items only.
The Directive excludes air-traffic-management equipment and systems within the
meaning of Article 1 of Council Directive 93/65/EEC of 19 July 1993 on the
definition and use of compatible technical specifications for the procurement of air-
traffic-management equipment and systems. However, that Directive has been
repealed since 20 October 2005. As a consequence, ground aeronautical radio
equipment now falls within the scope of the Directive.
Furthermore, since the same date, the Interoperability Regulation (EC) No 552/2004
covers some aeronautical radio equipment now within the scope of the Directive.
However, its provisions concern interoperability in air traffic management. Those
aspects are separate and additional to those dealt with by the Directive.
1.1.3.7 Others candidates ?
- Broadcast receivers intended to be exclusively connected by wire to DVB-C
CATV networks ?
7
Council Directive 96/98/EC of 20 December 1996 on marine equipment (OJ L 46, 17.2.1997), as amended by
Council and Parliament Directive 2002/84/EC (OJ L 324, 29.11.2002).
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1.1.4 Special measures regarding radio equipment at trade fairs, etc.

Radio equipment not (yet) allowed to be placed on the EU market, on grounds of non-
compliance with the RED, may be displayed at trade fairs and exhibitions provided a
visible sign clearly indicates that such equipment may not be marketed or put into
service in the EU. The use of such equipment is not permitted under the RED, but
some national authorities may allow very limited use (time, location, duration). The
relevant authorities in the concerned country should therefore be contacted if a
manufacturer wishes to demonstrate the use of such equipment.
1.1.5 Used and second-hand radio equipment
RED applies to used and second-hand products radio equipment from a third country
when they enter the EU or they are put into service in the EU for the first time
(chapter 2.3 Blue Guide).
Used and second-hand radio equipment already on the market have to comply with
the requirements in place at the moment of their placing on the market.
1.1.6 Non radio equipment incorporating radio products
Non radio products incorporating radio products have to comply with the
requirements of the RED.
1.1.7 Other applicable legislation
Radio equipment is generally also covered by environmental legislation such as RoHS
(Restrictions on Hazardous Substances) 8 , WEEE (Waste Electrical and Electronic
Equipment) 9 , REACH (Registration, Evaluation, Authorisation and Restriction of
Chemicals) 10 and EuP (ecodesign for Energy-Using Products) 11 . The relevant
requirements focus on the design, production and disposal phases of the life cycle of
electronic products.
1.2 Defining “radio equipment”

Radio equipment is defined in article 2 as an electrical or electronic product, which
intentionally emits and/or receives radio waves for the purpose of radio
communication and/or radio determination, or an electrical or electronic product
which must be completed with an accessory, such as antenna, so as to intentionally
emit and/or receive radio waves for the purpose of radio communication and/or radio
8
Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of
the use of certain hazardous substances in electrical and electronic equipment (OJ L 37, 13.2.2003).
9
Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical
and electronic equipment (WEEE) (OJ L 37, 13.2.2003).
10
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC)
No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006).
11
Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 establishing a framework
for the setting of ecodesign requirements for energy-using products and amending Council Directive
92/42/EEC and Directives 96/57/EC and 2000/55/EC of the European Parliament and of the Council (OJ L
191, 22.7.2005).
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determination; (2) ‘radio communication’ means communication by means of radio

waves. Radio waves meaning electromagnetic waves of frequencies lower than 3 000
GHz, propagated in space without artificial guide.
When a non-radio product includes a radio part, the part or, if it cannot be separated,
the whole product is subject to the provisions of the RED. So, for example, a PC that
incorporates a WLAN falls within the scope of the RED but in the case of a separate
WLAN card attached to a PC the PC is not covered by the RED (while the WLAN
card naturally is covered by the RED). In any event, the manufacturers’ instructions
must be respected when components or separate modules are connected.
1.3 Wires
Wires are not covered by the RED.
Do they have influence on the compliance of an equipment ?
1.4 Antennas
Antennas may be subdivided into “active” and “passive” types. “Active” antennas are
supplied with one or more electronic components interacting with the signal. All other
antennas are in general considered “passive”.
Taking in account the definition of a radio product in Article 1.1, passive antennas are
not covered by RED if placed on the market as a single commercial unit for
distribution or final use. If they are marketed together with a radio product, the overall
radio equipment including the antenna is subject to all the requirements of RED.
In contrast, active antennas (i.e. antennas including one or more active electronic
components that interact with the RF signal as e.g. amplifier) are covered by RED and
have to fulfil all requirements.
1.5 Test equipment (transmitting radio frequencies)

Test equipment used for radio equipment testing is not considered to be radio
communications equipment and is thus not covered by the Directive. However, the
use of the test equipment may need a permission from radio frequency authorities.
1.6 Jammers
This issue was specifically discussed in the context of mobile phone jammers (i.e.
equipment preventing the operation of GSM handsets). Since jamming, which is
inherent to their functional principle, cannot fulfil the essential requirements of the
Directive, the placing on the market and putting into operation of these devices is
banned.
1.7 Programmable equipment

Manufacturers need to classify equipment that can be programmed to use bands
whose use is not harmonised or could be used only under special licensing conditions
(Class 2 — see Section 4) and to inform users about existing restrictions.
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1.8 Components/sub-assemblies
Components/sub-assemblies that are either telecommunications terminal equipment or
radio equipment within the meaning of the Directive and are intended to be placed
and/or put into service on the European Union market fall within the scope of the
Directive.
1.9 Construction kits

Construction kits that when assembled fall within the scope of the Directive and are
intended to be placed on the market are covered by the Directive. The kit
manufacturer is responsible for compliance when the kit is assembled in accordance
with the instructions provided. In contrast, when a product is assembled from
components not intended to be part of a kit the responsibility lies with the person
making the product.
Passive components/sub-assemblies are excluded from the Directive as separate
items. However, when they are connected to radio equipment the manufacturer’s
instructions must be followed. Otherwise compliance with the Directive must be
shown by the responsible person incorporating the items into a final radio equipment.
1.10 Products for own use

Where a radio equipment is manufactured for own use, it is not considered to be
placed on the market12. The obligation to comply with the Directive occurs when it is
put into service and only for provisions which, at this stage, are still necessary for
ensuring the objectives of the Directive (assessment, technical file, etc., but for
instance not the marking).
Products imported for personal use are considered to be placed on the market at the
moment they enter EU territory, and from this point in time all the provisions
necessary to ensure the objectives of the Directive apply13.
1.11 Fixed installations

Fixed installations are not specifically mentioned in the Directive. They are not,
however, excluded, so that installations that conform to the definition of Article 1.1
(“radio equipment”) fall within the scope of RED. “Fixed installation” is understood
to mean a particular combination of several types of devices which are radio
equipment within the meaning of Article 1.1 and, where applicable, other devices,
which are assembled, installed and intended to be used permanently at a pre-defined
location. However, when a fixed installation is not placed on the market as a whole,
the requirements relating to CE marking and declaration of conformity are considered
not to apply to the installation as a whole. The person putting an installation into
service must assume the responsibilities of the manufacturer and perform the
appropriate conformity assessment. RED does not specify which conformity
assessment procedure is to be used unless the devices are sold as one complete
product.
12
Blue Guide, Chapter 2.3.2.
13
Blue Guide, footnote 30.
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“Additional radio equipment for fixed installations” is understood to mean radio

equipment which is specifically designed for incorporation into a given fixed
installation, and which is otherwise not commercially available. The concept of
placing on the market is considered not to apply to radio equipment meeting the
definition of “additional radio equipment for fixed installations”, provided that the
documentation accompanying the radio equipment specifies the fixed installation
concerned and the precautions to be taken for the incorporation of the radio
equipment into the installation in order not to compromise the conformity of the
installation. Hence the requirements for CE marking or declaration of conformity are
likewise considered not to apply. In other cases, all the provisions of the Directive
apply in full.
1.12 Comparaison R&TTED – RED

1.12.1 Changes in the scope
1.12.1.1 What is now covered
Following products are now covered by the RED
- Cochlear implants
- Broadcast receivers
- ….
1.12.1.2 What is not anymore covered
- Wired terminal equipment
- ….
1.12.2 Other changes
- No upper voltage limit for article 3.1.a for radio equipment
- No publication of the public interfaces from network operators + information
on the directive on competition
- Notification of radio equipment that uses frequencies which are not
harmonised throughout EU is not longer requested
- ….
1.13 Transitional provisions
1.14 General
Commission decisions taken according the R&TTED remain applicable under the
RED. Those are listed on the Commission’s webpage : [insert link on the relevant
homepage]
1.15 Products newly covered by RED
1.16 Products not any more covered by RED

….
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2 Obligations of the economic operators
2.1 General
This section will cover following topics:
- Explanation about the fact that manufacturers should develop their radio
equipment in a manner that it can be used in at least one country.
- CE marking
- Identification number of the notified body
- class identifier
- If really needed marking of radio equipment containing an RED component.
- Information about the specificities for RED about the information to the end
customer Article10 (10).
- What reasonable time period means in the context of the technical
documentation that has to be supplied to the administration.
2.2 Manufacturer
The manufacturer must:

- inform the user about the intended use of the radio equipment. This information
has to be sufficient to avoid interferences due to misuse of the radio equipment
(e.g. the maximum gain of the antenna to be connected to a WLAN);
- Manufacturers who place on the market products without an antenna or with an
antenna that is intended to allow replacement have a responsibility to provide
information on the general types and/or characteristics of antennas that may be
used with their equipment in order that the overall radio equipment remains
compliant. The guidance of the transmitter manufacturer has to be followed
when they are installed.
- inform the user on the packaging and in the instructions for use of the radio
equipment about the Member States or the geographic area within a Member
State in which the radio equipment is intended to be used. This information is
not required for Class 1 equipment, which by definition can be used anywhere
in the European Union;
- alert the user to potential restrictions or requirements regarding the authorisation
to use the radio radio equipment that may apply in certain Member States (e.g.
use restricted indoors);
- in the case of terminal radio equipment, inform the user about the interfaces of
the public telecommunications networks to which the radio equipment is
intended to be connected;
- provide the user with a copy of the declaration of conformity. This obligation
may be fulfilled by choosing one of two possibilities:
– a copy of the original declaration of conformity is made available to the
user;
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– the following informal statement on compliance with the Directive is made

in any of the languages of the European Union:
[Name of manufacturer] hereby declares that this [type of equipment] is in
compliance with the essential requirements and other relevant provisions of
Directive 1999/5/EC.
This statement has to be accompanied by the exact address (mail address or
website) where a copy of the original declaration of conformity may be
found or obtained.
This information has to be presented in such a way that the user can
readily understand it. Typically, this will necessitate translation into every
local language (required by national consumer laws) of the markets where
the equipment is intended to be sold. Illustrations, pictograms and using
international abbreviations for country names may help reduce the need for
translation.
2.3 Authorised representative
2.4 Importer
2.5 Distributor
3 ESSENTIAL REQUIREMENTS
3.1 General
As a large part of Union harmonisation legislation, RED lays down “essential
requirements”14, which are mandatory provisions for the protection of the public and
the general interest and are designed to ensure a high level of protection.
In the RED, two nature of essential requirements are defined:
- essential requirements applicable to all radio equipment;
- essential requirements applicable only to certain type of radio equipment
pursuant a Decision.
3.2 Essential requirements applicable to all radio equipment

All radio equipment shall be constructed so as to ensure15:
14
More information on the principle of essential requirements can be found in Chapter 4.1 of the Blue Guide.
15
Articles 3.1 and 3.2 of the RED
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- the protection of health and safety of persons and of domestic animals and the
protection of property, including the objectives with respect to safety
requirements set out in Directive 2014/35/EU, but with no voltage limit
applying;
Therefore, battery-operated equipment such as a GSM handset is also subject to
this essential requirement and should ensure that when it is used as intended, the
limits for human exposure to electromagnetic fields are respected.
This essential requirement covers all health and safety risks arising from the use
of equipment, e.g. electrical, mechanical and chemical (e.g. emission of
aggressive substances) as well as (but not exclusively) health aspects relating to
noise, vibration and ergonomic aspects .
- an adequate level of electromagnetic compatibility as set out in Directive
2014/30/EU.
- that it both effectively uses and supports the efficient use of radio spectrum in
order to avoid harmful interference.
Recital 10 RED states :
“In order to ensure that radio equipment uses the radio spectrum effectively
and supports the efficient use of radio spectrum, radio equipment should be
constructed so that: in the case of a transmitter, when the transmitter is
properly installed, maintained and used for its intended purpose it generates
radio waves emissions that do not create harmful interference, while unwanted
radio waves emissions generated by the transmitter (e.g. in adjacent channels)
with a potential negative impact on the goals of radio spectrum policy should be
limited to such a level that, according to the state of the art, harmful
interference is avoided; and, in the case of a receiver, it has a level of
performance that allows it to operate as intended and protects it against the risk
of harmful interference, in particular from shared or adjacent channels, and, in
so doing, supports improvements in the efficient use of shared or adjacent
channels.”
3.3 Essential requirements applicable to certain type of radio equipment

Commission is empowered to adopt delegated acts specifying which categories or
classes of radio equipment are concerned by each of the following requirements16:
- radio equipment interworks with accessories, in particular with common

chargers;
- radio equipment interworks via networks with other radio equipment;
- radio equipment can be connected to interfaces of the appropriate type
throughout the Union;
- radio equipment does not harm the network or its functioning nor misuse
network resources, thereby causing an unacceptable degradation of service;
16
Articles 3.1 and 3.2 of the RED
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- radio equipment incorporates safeguards to ensure that the personal data and
privacy of the user and of the subscriber are protected;
- radio equipment supports certain features ensuring protection from fraud;
- radio equipment supports certain features ensuring access to emergency
services;
- radio equipment supports certain features in order to facilitate its use by users
with a disability;
- radio equipment supports certain features in order to ensure that software can
only be loaded into the radio equipment where the compliance of the
combination of the radio equipment and software has been demonstrated.
Decisions on essential requirements applicable to certain type of radio equipment are
listed on the Commission’s webpage: [insert link on the relevant homepage]
4 SPECIFIC PROVISIONS
4.1 Software defined radio

…….
4.2 Registration of radio equipment types within some categories

……
5 INTERFACE REGULATIONS & SPECIFICATIONS
5.1 Notification of radio interface specifications

Interface regulations (often called “interface specifications” or even “interface
requirements”) relate to the Member States’ obligation under Article 8.1 of the RED
to notify the Commission of the interfaces which they have regulated.
A common template has been developed with a respective guide. Those documents
are available on … [insert link on template and guide].
The relevant information may be found on the national websites of the spectrum
authorities [http://ec.europa.eu/enterprise/R&TTE/weblinks.htm.] or also in the EFIS
database [http://www.efis.dk].
5.2 Assignment of radio equipment classes

The Commission has to establish, based on Article 8.2 of the RED, the equivalence
between these national radio interface specifications.
The Commission shall adopt implementing acts establishing the equivalence between
notified radio interfaces and assigning a radio equipment class, details of which shall
be published in the Official Journal of the European Union.
Currently, two classes are defined :
- Class 1: radio equipment that can be operated without any restriction in the
whole EU and EFTA.
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- Class 2 : radio equipment whose placing on the market or putting into service or
use is subject to restrictions. Examples of such restrictions are:
- frequency available and allowed for that application in certain Member
States only;
- individual licence needed to use the specific radio equipment;
- indoor use only.
To be considered Class 1 equipment, radio equipment must respect the technical
characteristics of the subclass concerned (the radio interface). The technical
parameters to be respected for a given subclass can be viewed by clicking on the
number associated with that subclass.
5.3 HARMONISED STANDARDS

5.3.1 Introduction
Chapter 4.1.2 of the Blue guide gives a deep information on the role and application
of harmonised standards.
The application of harmonised standards is voluntary but has the advantage of giving
a “presumption of conformity” with the essential requirements corresponding to its
scope. If a manufacturer chooses not to follow a harmonised standard or only partly,
he has the obligation to prove that his radio equipment is in conformity with the
essential requirements by other means and to provide a full technical justification.
The Commission website gives a list of titles and references to harmonised standards
in relation to radio equipment at: http://ec.europa.eu/enterprise/rtte/harstand.htm.
The date of cessation of presumption of conformity of the superseded standard should
not be confused with the date of withdrawal (“dow”) of a superseded standard
indicated by a standards organisation, although normally both these dates are
identical. The dow has no meaning within the concept of the RED.
The cessation of presumption of conformity applies only to those individual items
which are not yet placed on the market. For an individual radio equipment already
placed on the market, the fact that one or more standards it conforms to no longer
confer presumption does not alter its conformity, nor the validity of its DoC.
Any current reference of a standard taken from the latest valid OJEU list may be used
as a harmonised standard until the date of cessation of presumption of conformity is
reached.
5.3.2 Generic harmonised standards vs product specific harmonised standard
A manufacturer which has the intention to apply a harmonised standard for the
compliance assessment of its products, has to apply in priority the product specific
harmonised standard and only if this one is not available, the generic one. If never the
less he would choose to apply the generic one, he would have to go through the route
of a notified body.
5.3.3 Revision of harmonised standards
During a transitional period, both the old and the revised standards give a presumption
of conformity, provided that they both meet the conditions for doing so.
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If the manufacturer chooses to apply a harmonised standard, he has to ensure that his
radio equipment complies with the version of the harmonised standard which gives a
presumption of conformity at the time of its declaration of conformity.
Manufacturers who have applied a superseded harmonised standard and do not wish
to apply the new harmonised standard need to consult a notified body in order to
continue placing radio equipment on the market.
Chapter 4.1.2.5 of the Blue Guide gives detailed information on the revision of
harmonised standards.
5.4 CONFORMITY ASSESSMENT PROCEDURES
5.5 Introduction
Radio equipment is required to comply with the essential requirements referred to in
Article 3 of the RED. The manufacturer has to demonstrate the compliance of radio
equipment by applying a conformity assessment procedure. A different conformity
assessment may be used for each essential requirement. The procedures are detailed in
Article 17 and Annexes II, III and IV of the RED.
Technical documentation has to be prepared to provide evidence that the radio
equipment complies with the essential requirements. This includes evidence that the
radio equipment complies with the relevant harmonised standards or, if harmonised
standards are not used or used only in part, a detailed technical justification.
Harmonised standards under the LVD (2014/xx/EU) and the EMCD (2014/30/EU)
also have the same status under the RED.
At the end of the conformity assessment, the manufacturer or his authorised
representative in the European Union is required to complete an EC Declaration of
Conformity and affix the CE marking on each radio equipment.
After the conformity assessment has been carried out, the manufacturer must take all
measures necessary in order that the manufacturing process ensures compliance of the
manufactured radio equipment with the technical documentation and with the
essential requirements of the R&TTE Directive that apply to it.
5.6 Applicable conformity assessment procedures

5.6.1 Introduction
The following procedures are applicable depending on the type of radio equipment
and whether or not harmonised standards are used.
The conformity assessment procedures laid down in the RED are ordered
incrementally depending on their complexity (Annex II is simpler than Annex III, and
so on). Higher conformity assessment procedures may always be applied.
5.6.2 Internal production control (Annex II)
This procedure may be applied …
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(a) internal production control set out in Annex II; (b) EU-type examination that is
followed by the conformity to type based on internal production control set out in
Annex III; (c) conformity based on full quality assurance set out in Annex IV.
5.6.3 EU-type examination followed by the conformity to type based on internal

production (Annex III)
This procedure may be applied ….
-
5.6.4 Full quality assurance (Annex V)
This procedure may be applied by manufacturers that operate an approved quality
system for design, manufacture and final inspection and testing of radio equipment. It
is available for all equipment within the scope of the Directive irrespective of whether
or not harmonised standards are applied.
5.7 Testing
Required tests may be carried out by the manufacturer or by a third party. No formal
accreditation is required to carry out the tests. The manufacturer remains responsible
in all cases for the compliance of his radio equipment.
5.8 Documentation required by the conformity assessment procedures

This comprises the technical documentation and the EC Declaration of Conformity.
Records and correspondence relating to the conformity assessment procedures must
be in an official language of the Member State where the procedure is carried out, or
in a language accepted by the notified body involved.
5.8.1 Technical documentation
The manufacturer draws up technical documentation providing evidence of the
conformity of the radio equipment with the essential requirements of the Directive.
Annex V of the RED describes the minimum content of the technical documentation.
International standard EN ISO/IEC 17050-2:2004 “Conformity assessment —
Supplier’s declaration of conformity — Part 2: Supporting documentation”, with the
exception of clause 5.2a), is generally applicable to establishing and maintaining
technical documentation for the purposes of the RED.
The purpose of the technical documentation is show the conformity of the product
with the essential requirements of the RED. Even if it is not intended to be a
comprehensive design and manufacturing dossier, it should contain all information
necessary to identify the radio equipment concerned and assess its compliance.
Modifications with potential impact on the way the product meets the essential
requirements require a new assessment. The technical documentation should follow
the life cycle of the radio equipment and show the different modification and the
according re-assessment of the compliance.
Where software or firmware affects compliance, it should be explicitly referenced and
any user-configurable options explained.
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5.8.2 EC Declaration of Conformity

The compliance of radio equipment with all relevant essential requirements is
declared in an “EC” Declaration of Conformity (DoC) issued by the manufacturer —
inside or outside the European Union — or by his authorised representative in the
European Union.
As the DoC is an “official” declaration, it must be signed by a person “empowered to
bind the manufacturer or his authorised representative located in the European
Union”.
Annex VI of the RED lay down the content and the layout of the DoC.
Furthermore, in cases where several directives apply simultaneously to the radio
equipment, the manufacturer or the authorised representative has to issue only one
DoC covering all applicable legislation (a folder compounded by several DoC is to be
considered as a single DoC).
Manufacturers should not confuse the DoC with other documents as conformity
certificates from accredited test lab, Notified Body certificate, …. The two documents
may be easily distinguished: the DoC is signed by the manufacturer, while the other
document is signed by the notified body.
5.9 Marking
The marking set out below must be affixed to the radio equipment or to its data plate
and have a minimum height of 5 mm. The elements should be easily readable and
indelible. They may be placed anywhere on the radio equipment case or in its battery
compartment. No tool should be needed to view the marking.
This marking should also be reproduced on the packaging (if any) and on the
accompanying documents. Although the word “documents” appears in plural in the
text of the Directive, the intention is that the CE marking should be reproduced at
least in one set of accompanying documents (e.g. instruction manual) and be easily
identified by the user and/or the surveillance authorities.
Where it is “not possible or warranted on account of the nature of the radio
equipment” to have the marking affixed to the radio equipment or to its data plate, the
CE marking may be placed on the packaging, if any, and in the accompanying
documents. The Blue Guide (Chapter 7.3) gives more information about the
circumstances in which this exemption is allowed.
The R&TTE Directive does not forbid affixing the CE marking in more than one
place, for example, on the packaging as well as inside the radio equipment.
Affixing the CE marking denotes compliance with all applicable EC “new approach”
directives. As a consequence, radio equipment that does not fall within the scope of
the R&TTE Directive or of any other directives requiring CE marking cannot bear the
CE marking.
The R&TTE Directive forbids the affixing of marks that are similar to the CE
marking, as well as those that are likely to mislead third parties in relation to the
meaning of the CE marking, e.g. by giving the impression that they are needed in
order to have free access to a Member State’s market.
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For radio equipment under the R&TTE Directive, the CE marking is the only marking
having regulatory effect regarding R&TTE requirements within the European Union.
Other directives may impose additional regulatory marking.
5.9.1 Complete CE marking
The following picture shows an example of CE marking. The “CE” mark is always
required. The other elements, notified body number (“NBnr” replaced by the four-
digit identification number of any notified body involved) and class identifier (alert
sign), may or may not be present depending on the particular circumstances.
5.9.2 CE mark
The R&TTE Directive requires that radio equipment bears the CE mark as an
attestation of compliance with the R&TTE Directive. The CE mark may, however, be
required to show conformity with other directives, in which case its presence attests to
compliance with all applicable directives.
5.9.3 Identification number of the notified body

The CE marking should include the identification number of the notified body
involved in the conformity assessment procedure. Where more than one notified body
is involved, all the identification numbers of all notified bodies involved should be
indicated. The identification number must have the same height as the CE marking.
5.9.4 Other markings
The R&TTE Directive requires that radio equipment be identified by:
- type;
- batch and/or serial numbers;
- the name of the manufacturer or the person responsible for placing the radio
equipment on the market.
This information is needed to allow the radio equipment to be identified. The
identification of the radio equipment must unambiguously correlate with the DoC and
the technical documentation.
Although not explicitly mentioned, this information needs to be on the radio
equipment (or its data plate). This will establish a link to the technical documentation
where more information is given.
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5.9.5 Marking of radio equipment containing an R&TTE component

Radio equipment containing an R&TTE component must be marked in the following
way:
- Radio equipment which at the time of placing on the market contains as an
integral part one or more components that are covered by the R&TTE Directive
and are not intended to be removed by the user should be marked pursuant to
the R&TTE Directive. In addition, the user documentation for the radio
equipment should comply with the Directive and e.g. indicate geographic
restrictions on use.
- Radio equipment which at the time of supply has provision for later user-added
components that fall under the R&TTE Directive but are otherwise not covered
by the Directive (e.g. computers without an integral modem and/or wireless
capability) should not be marked according to the Directive.
6 ADMINISTRATIVE REQUIREMENTS
6.1 Introduction
In addition to the conformity assessment procedure, the R&TTE Directive lays down
some administrative requirements to be fulfilled.
6.2 Information for the user
7 NOTIFIED BODIES
7.1 Introduction
If the manufacturer has not applied (fully) all relevant harmonised standard applicable
to the radio equipment in order to cover Article 3.2 and 3.3 of the RE Directive, the
manufacturer or his authorized representative must involve a RE Directive Notified
Body (NB) in the conformity assessment procedure.
The manufacturer can then apply either the Annex III or the Annex IV procedure.
For the safety aspects and the EMC aspects as covered by Article 3.1 (a) and 3.1 (b)
of the RED, the manufacturer has either the choice to perform the assessment without
involving a NB Annex II, the standard route) or on a voluntary basis request a NB to
apply the Annex III or Annex IV procedure.
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7.2 General concept

Notified bodies are designated by the competent authorities of the EU Member States,
EFTA countries (EEA members) and other countries with which the EU has
concluded Mutual Recognition Agreements (MRAs) to perform the conformity
assessment tasks described in the Directive. The authorities verify that these bodies
meet the criteria given in Article 26 to 28, inclusive, of the Directive, i.e. that they can
demonstrate the required level of resources, competence, independence, impartiality
and integrity. This is subject to surveillance at regular intervals. The notified body
shall be assessed in accordance to the requirements of 768/2008/C, EA2/17 and the
associated accreditation standards ISO 17065 or ISO 17020. Evidence of this
assessment shall be demonstrated during the notified body accreditation assessments
and be available to the designating authority. EU Accreditation bodies may work
with the RED CA and EU member state authorities to determine general notified body
technical competence assessment guidelines, as the technical competence assessment
details are not dealt with by 768/2008/EC, EA2/17 or the accreditation standards ISO
17065 or ISO 17020. MRA partners are expected to follow these technical
assessment guidelines during their assessments. The intent is to have a common
minimum competence requirement for notified bodies for the Radio Equipment
Directive.
The Commission publishes a list of bodies in the OJEU and keeps it up to date. There
is also a website with a list of appointed EU notified bodies:
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm.
The lists include the address details of each body as well as the tasks for which it has
been notified.
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Under the Radio Equipment Directive the notified body may perform up to 2 different
conformity assessment tasks following the procedures in Annexes III and IV of the
Directive.
- EU-Type Examination (Module B):
Examine the technical design of the radio equipment and verifying and attesting
that the technical design of the radio equipment meets the essential requirements
of the Directive. (Annex III of the Directive);
- Conformity based on full quality assurance (Module H):
Assess and perform periodic surveillance of manufacturers’ full quality
assurance systems (Annex IV of the Directive).
Notified bodies can be designated for one or more of these tasks and may be
appointed to deal with all or only selected types of radio equipment. When designated
for all types of radio equipment, they must be able to assess all radio equipment for all
of Article 3 essential requirements. When designated for selected types of radio
equipment, they must be able to assess those radio equipment for all of Article 3
essential requirements.
The notified body will need to have policies and procedures in place that distinguish
between tasks carried out as a notified body and any other activity in which the
organisation is engaged.
It should be noted that the body cannot, in its role as a notified body:
- carry out testing of equipment it is assessing;
- prepare test reports for equipment it is assessing;
- design equipment it is assessing;
- sign or issue a manufacturer’s declaration of conformity;
- act as an agent for the manufacturer;
- provide consultancy
7.2.1 Annex III procedure — Examination of technical documentation
The Directive requires compliance when equipment is “properly installed and
maintained and used for its intended purpose”. The body should therefore note any
inconsistencies between obvious uses of the equipment and the stated intended
purpose so that its EU-Type Examination may be suitably qualified and is not open to
misinterpretation.
The applicant specifies which aspects of the essential requirements the notified body
is to assess. In all cases the notified body shall assess the Article 3.2 compliance. As
an example the manufacturer could require the EMC aspects to be covered (Art. 3(1)
(b) of the Directive) and the effective use of the spectrum (Art. 3(2) of the Directive)
and not require the safety issues to be covered (Art. 3(1) (a)of the Directive).
An aspect relevant to the intended purpose may be the number of units of equipment
likely to be put into service and their overall potential for harmful effects to networks
or the radio spectrum.
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Control of the spectrum remains essentially a national matter and so it is essential to

consider the spectrum plan for the intended location(s) of use and any relevant
interface regulations for the
Member State(s) concerned. In this context “location” implies not only the physical
placement but also any relevant environmental factors. In extreme cases, it may be
necessary to liaise directly with the spectrum authority for the relevant Member State.
The notified body must review the documentation and, if the review concludes that
the documentation demonstrates compliance with the requirements of the Directive,
the notified body shall issue a report indicating the work perform and its findings.
Based on this notified body report the notified body can then issue an EU-Type
Examination Certificate to the applicant.
In the case of the notified body report not coming to a positive conclusion that the
radio equipment concerned, satisfying the requirements of the Directive, the notified
body shall refuse to issue an EU-type Examination certificate. The notified body shall
inform the applicant accordingly giving detailed reasons for its refusal in the report.
Refusal by the notified body to issue an EU-Type Examination certification shall
follow the process in Article 36 of the Directive.
The notified body must base its EU-Type Examination Certificate on the requirements
of the Directive and their professional assessment of the technical documentation
taking due account of relevant standardisation, other technical references and
professional decision available at that time.
When compliance of the radio equipment is confirmed by the notified body report the
EU-Type Examination Certificate of the notified body cannot generally be conditional
or limited in time (apart from the Validity Date of the Certificate). An exception is
made if technical requirements have to be specified in order to be compliant (such as
adding a specific filter to the radio equipment).
The notified body should maintain records documenting the rationale used to arrive at
a particular decision. The records should identify any documents referenced in the
assessment and the particular parameters applied to determine compliance with the
essential requirements.
Annex III of the Directive provides for the notified body to give a report and an EU-
Type Examination Certificate based on the technical documentation which also
requests the applicable technical documentation detailed in Annex V of the directive
is reviewed. Further Annex III does not provide guidance on the format and content
of the EU-Type Examination Certificate. In all other respects, a notified body is free
to choose its own format and may include additional information such as the
manufacturer’s details, conformity assessment procedure, reference standards,
intended purpose and other remarks/observations.
However the notified body should take account of the following aspects for the
Certificate:
Title “Directive 2014/53/EU — Notified Body EU-Type Examination Certificate” or
similar text and avoiding the use of words such as “opinion” and “declaration”.
Insert on the Certificate:
- Notified body Name, address etc., (logo if relevant).
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- Notified body number.

- EU-Type Examination Certificate number - this shall be the unique number of
EU-Type Examination Certificate. A revision number and/or copy number shall
be included if applicable.
- Date of issue of the Certificate and its Validity
- Applicant details. Name, address etc. of the party requiring the EU-Type
Examination Certificate.
- Scope of examination whether the certificate is covering health & safety
(Article 3(1) (a)), EMC (Article 3(1) (b)), radio spectrum use (Article 3(2))
and/or special radio features (Article 3(3) (a)-(f)).
- Clear identification of the radio equipment. The goal is to give the minimum
information from the following list such that a third party would be able to
uniquely identify the item in question.
- Description of radio equipment, including brand/trade name, model/type
designation, hardware and software (where it affect the RE Directive
conformity) revision.
- Reference of any build status/design documentation taken into account.
- Technical documentation identification
- Unique identification of the documentation etc. taken into consideration
irrespective of the actual physical format of the documentation
- Certification text - the text stating whether or not the radio equipment is
compliant.
- Authorised signatory (signature block including printed name of the signatory).
7.2.2 Annex IV procedure — Conformity based on full quality assurance
Assessments to verify compliance of the quality management system with the
requirements must be performed under the responsibility of the notified body. Where
the manufacturer’s quality system has already been certified to related quality plans
by an accredited certification body the notified body will normally not duplicate
assessments of compliance with those requirements, but will seek assurance that the
Directive-specific issues have been taken into account.
The notified body should pay particular attention to the way the directive regulatory
obligations are handled under the quality system.
The notified body needs to be informed about significant changes to the
manufacturer’s organisation or quality system. The notified body will then verify the
information and decide whether further audit(s) are necessary.
Findings of audits will be recorded in an audit report. The report will be made
available to the applicant together with required changes and actions (if any).
The notified body will perform follow-up audits at least once a year. The frequency of
follow-up audits may depend on issues such as the depth of the audit, the size of the
facilities and results of previous audits. The audit results and follow-up actions must
be formally documented and made available by the notified body on request.
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Inspection and test records will need to be kept for a timescale agreed with the
notified body and as described in the quality plan or equivalent documentation. In any
event, the timescale must not be less than 2 years.
There is no specific time limit placed on notified bodies for retention of
documentation, but it seems appropriate for the notified body to retain its own records
for the same period as the manufacturer.
The manufacturer must retain the declarations of conformity as a record of what he
has placed on the market via the Annex V route. The notified body must have access
to these documents, and to all relevant documentation supporting the declaration of
conformity.
7.3 Subcontracting
The notified body can formally subcontract limited tasks, as long as these can be
defined as substantial and coherent parts of its operation and are still under its control.
Subcontracting does not therefore entail the delegation of powers or responsibilities.
NB decisions are always solely issued in the name and under the responsibility of the
notified body. The notified body shall ensure the competence of subcontractors in
accordance with 768/2008/EC, EA2/17 and the associated accreditation standards ISO
17065 and ISO 17020. Evidence of this assessment of subcontractor competence shall
be demonstrated during the notified body accreditation assessments and be available
to the designating authority upon request.
7.4 Information exchange
Article 36 and Annex III and IV of the Directive contain requirements for notified
bodies regarding providing specific information to certain organisations such as other
notified bodies, authorities, etc.
To comply with these requirements may create some difficulty. Notified bodies
should check the NB coordination Group: the Radio Equipment Directive Compliance
Association – REDCA to check whether the REDCA has made available procedures
to facilitate an easy exchange of information.
7.5 Coordination between notified bodies
Recognizing that it is necessary for the conformity assessment routes to be applied
consistently by all parties in order to achieve an open and competitive market
throughout Europe, the Radio Equipment Directive Compliance Association
(REDCA) has been set up. (See Annex X)
The REDCA contributes to the effective implementation of relevant legislation in
cooperation with the Committee set up under the Directive (i.e. TCAM) and facilitates
the convergence of conformity assessment practices in the regulatory sphere. The
REDCA liaises with relevant organisations such as ETSI, ECC and ADCO RED.
The REDCA issues information sheets, called Technical Guidance Notes — TGNs —
which have been drawn up to assist the notified body in its task. These TGNs may
also contain valuable background information for manufacturers. The approved TGNs
are therefore placed in the public domain and serve as general reference
(www.redca.eu).
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Furthermore REDCA provides Reference documents for its member containing

valuable information to support the work of the notified bodies.
The notified body should also:
- be fully aware of the (national) spectrum plans in Europe, noting these are not
always harmonised!
- know the Radio Equipment Directive as well as other EU legislation that
simultaneously is applicable to Radio Equipment;
- be able to interpret essential requirements on the basis of available harmonised
standards.
- maintain knowledge of the current wireless state of the art including following
the developments in European standardisation.
7.6 Complaints regarding the service provided by notified bodies
Notified bodies are required to have a policy and procedure for the resolution of
complaints received from clients or other parties.
Where a manufacturer is dissatisfied with the service performed, he should file a
complaint with the notified body in question.
A complaint can also be filed by the manufacturer with the national designating
authority.
Where non-compliant radio equipment has been subject to the conformity assessment
procedure involving the service provided by a notified body, the authority supervising
the notified body will need to take appropriate action and inform the Commission and
the other Member States accordingly.
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8 Market surveillance and enforcement

Member States are required to take all appropriate measures to ensure that equipment
is placed on the market and/or put into service only if it complies, when properly
installed, maintained and used for its intended purpose, with the requirements of the
Directive.
The Directive itself sets rules for market surveillance in articles 39-43 also referring
to Regulation 765/2008. Detailed provisions on how surveillance should be organised
and carried out in the Member States are given in the Blue Guide.
In addition to the Blue Guide there are other guides for horizontal questions regarding
market surveillance:
Commission has prepared a “horizontal market surveillance guide” and there are
“horizontal good practices on market surveillance”. These documents can be accessed
via the links in the annex to this guide.
A list of the Member State surveillance authorities can be found at:
http://ec.europa.eu/enterprise/R&TTE/marksur.htm.
The Directive enables the surveillance authorities to gain access to information on
equipment. In particular, it requires the declaration of conformity and technical
documentation to be retained for inspection by them. This information must be made
available by the manufacturer, by his authorised representative established within the
European Union, or where neither is in the European Union, by the importer or person
responsible for placing the apparatus on the market or by the distributor. The
information cannot be withheld on the ground that it contains confidential information
(i.e. commercial confidentiality). The surveillance authorities themselves have a duty
to respect confidentiality.
Surveillance authorities may also, in accordance with their national laws, check and
test products sampled in the market or distribution chain under their jurisdiction.
National market surveillance authorities have the legal right to obtain the necessary
technical information to check conformity with the essential requirements of the
Directive. National market surveillance authorities are under the legal obligation to
ensure that technical information they collect remains confidential.
Manufacturers therefore have no grounds for fearing that sensitive information they
provide to national market surveillance authorities in the context of market
surveillance might be disclosed.
Surveillance activities may arise as a result of a complaint or random check or as part
of a systematic programme. Where problems are found, the follow-up will depend on
the seriousness of any non-compliance. In cases of risks or where there is a failure to
implement adequate remedial measures in a timely manner, withdrawal from the
market may be imposed and the surveillance authority concerned will trigger the
procedure under Article 40 ff. of the Directive. Under this procedure, formal
notification of the action taken and the reasons for it is made to the Commission. The
Commission will then inform the other Member States and, in due course, give an
opinion on the action taken:
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If the market surveillance authority of member state A finds a (presumed) non-

compliant product manufactured or imported by a company based in another member
state (B), the first authority (A) contacts the manufacturer / EU importer based in
country B and requests corrective action in order to address the non-compliance on
the whole EU market.
At the same time the market surveillance authority in the country B is informed of the
non-compliance found and of the corrective action requested of the EU importer /
manufacturer based in country B.
If the manufacturer / importer does not answer market surveillance authority A or
does not take appropriate corrective action, then member state B provides legal
assistance.
If requested in the Directive (products presenting a risk) market surveillance authority
A notifies also the Commission and other member states.
If no objection is raised or if the Commission and member state B consider it justified,
MSA B contacts the manufacturer / EU importer to request corrective action in
relation to sales made throughout the whole EU. All other Member States need to
address the local distributors to complement corrective action in their territory.
A cooperation of the he surveillance authorities is essential for the working of the
single European market, for example in the ADCO RED (Group on Administrative
Cooperation).Via the ICSMS (and RAPEX as applicable) systems the dissemination
of information in a market surveillance intervention is important to promote effective
cooperation and coordination between MSAs throughout Europe. It helps avoiding
unnecessary duplicate effort and at the same time ensures that non-complying
products are taken from the market as early as possible in the whole EU.
Through cooperation of market surveillance authorities among each other and with
the Commission the identification of risks, results of testing carried out, (provisional)
restrictive measures taken, contacts with the economic operators concerned and
justification for action or inaction should be harmonised as restrictive measures must
be proportionate and aligned throughout the Single Union Market in cases of non-
compliance.
8.1.1 Concept of “holding at the disposal of the authorities”
The Directive requires that:
“The manufacturer must establish the technical documentation … and he or his
authorised representative established within the Community must keep it for a period
ending at least 10 years after the last product has been manufactured at the disposal of
the relevant national authorities of any Member State for inspection purposes.”
This provision also applies to the DoC.
The concept of “holding at the disposal of the authorities” means:
1. The manufacturer or his authorised representative established within the

European Union is responsible for making available the EC Declaration of
Conformity and the technical documentation.
2. This person must present the EC Declaration of Conformity and the technical
documentation upon request from the competent authorities, within a reasonable
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time (usually 2 weeks). He has to take positive actions to make it actually

available to those authorities (send a copy of the file, email, etc.).
3. Failure to present the information within a reasonable period in response to a
request by the authorities can constitute an infringement of one of the
administrative requirements of the R&TTE Directive. This may lead to further
measures because it cannot be proved that a conformity assessment was carried
out before the radio equipment was placed on the market.
4. The authorised representative established within the European Union does not
need to be in physical possession of the documents. The documents can be kept
on the manufacturer’s premises, even if the manufacturer is outside the European
Union.
5. Where neither the manufacturer nor the authorised representative is present in the
European Union, the responsibility for the provision of this information rests with
the person first placing the radio equipment on the EU market (importer).
6. The manufacturer is obliged to provide the documentation and cannot argue that
it contains confidential information (e.g. commercial confidentiality).
7. It has been agreed by those concerned that the information to be made available
on request need not be an original document but can be a copy. In addition, the
technical documentation can be kept in any format (for example in hard copy or
on CD-ROM or any other electronic storage medium) which allows it to be made
available within a reasonable period of time (e.g. 2 weeks). Information should be
provided in an appropriate and usable form.
8. If the documents are in a language that is not understood by the competent
authority, it is considered mandatory to provide the competent authority with a
translation of the most important documents.
There is no obligation for the technical documentation to accompany the radio
equipment nor is it a legal obligation under the Directive for manufacturers to
make available technical documentation to their customers.
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ANNEX 1 — Organisations and committees involved
ADCO RED (Group on ADministrative COoperation) is a group formed by the

market surveillance authorities of the Member States and countries that have
implemented the R&TTE Directive. The group promotes administrative cooperation
in the fields of market surveillance, joint market surveillance campaigns, exchange of
information and non-conformity issues17.
CENELEC (European Committee for Electrotechnical Standardisation) is recognised

as an official European standards organisation by the European Commission and
works under mandates from the Commission to prepare harmonised standards for the
Directive. Membership is restricted to representatives of national standardisation
bodies. CENELEC activities concerning the Directive relate to Article 3(1)(a) and
3(1)(b).
http://www.cenelec.org/Cenelec/Homepage.htm
CENELEC standards may be purchased through one of the national member bodies:
http://www.cenelec.org/Cenelec/CENELEC+in+action/Web+Store/Standards/default.
htm.
ERO (European Radiocommunications Office) is the permanent office supporting the

ECC (Electronic Communications Committee of the CEPT), the committee that
brings together the radio and telecommunications regulatory authorities of the 48
CEPT member countries. The ERO is charged by the Commission with maintaining
information about the classification of equipment in accordance with the R&TTE
Directive.
http://www.ero.dk/rtte
ETSI is recognised as an official European standards organisation by the European

Commission and works under mandates from the Commission to prepare harmonised
standards for the Directive. Membership is open to all interested parties. ETSI
activities concerning the Directive relate mostly to Article 3(2), 3(3) and, in part,
3(1)(b).
http://www.etsi.org/WebSite/homepage.aspx
ETSI standards can be downloaded free of charge via the Publications Download
Area application:
http://pda.etsi.org/pda/queryform.asp.
ICNIRP (International Commission on Non-Ionising Radiation Protection) has no

formal link with the Directive but, in those cases where there are no harmonised
standards covering EMF hazards for a particular type of radio equipment, ICNIRP
guidance may be helpful in compiling a basis for compliance with this aspect of
Article 3(1)(a).
http://www.icnirp.de/pubEMF.htm
17
See also Blue Guide, Chapter 8.6.
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REDCA (Radio Equipment Directive Compliance Association) provides a forum for

organisations concerned with the compliance of radio equipment with regulations and
technical standards in the European Economic Area, as well as in the Countries that
have a Mutual Recognition Agreement with the EU, such as the USA, Canada, Japan,
New Zealand and Australia.
See: http://www.redca.eu
It has specific responsibilities in respect of Notified Bodies appointed under EU

Directive 2014/53/EU (Radio Equipment Directive). In this context it has published a
number of Technical Guidance Notes that can be accessed by following the
"Download Area" link alongside.
Membership of REDCA is open to any notified body, testing, manufacturing or other

organisation that is willing to follow the aims and objectives set out in the
Associations Rules and Constitution. An application form and a full copy of the Rules
can be found by following the "Download Area" link alongside.
The Association meets twice a year in a location within the EEA. All meetings are
open for members only. These meetings are ideal to discuss matters with important
players in the field such as representatives of the EU Commission, ECC, ETSI,
ADCO RED and authorities from MRA countries.
REDCA operates a mail server where members can ask questions that will trigger
answers and comments from the experts within the Association. These discussions
provide material to be stored on the protected database for future reference by the
members. Furthermore the Association has a specific protected area on the CIRCABC
website, operated by the EU Commission, where all documents are stored for access
by the members only.
RSC (Radio Spectrum Committee) assists the Commission in the development and
adoption of technical implementing measures aimed at ensuring harmonised
conditions for the availability and efficient use of radio spectrum, as well as the
availability of information related to the use of radio spectrum. It has no formal remit
concerning the Directive but its activities have a strong influence on the definition of
equipment classes in the TCAM and their maintenance by the ERO. For this reason,
joint meetings of the RSC and TCAM take place from time to time.
http://ec.europa.eu/information_society/policy/radio_spectrum/activities/rsc_work/ind
ex_en.htm
TCAM (Telecommunication Conformity Assessment and Market Surveillance

Committee) was set up under the R&TTE Directive to assist the Commission. It is
made up of representatives of the Member States and chaired by the Commission.
Representatives of industry, standards bodies, the ERO and notified bodies are also
invited to participate on a non-voting basis. The Commission is obliged to consult the
TCAM on matters relating to shortcomings in harmonised standards, in cases where a
safeguard measure has been taken to remove a product from the market or where
authorisation to disconnect equipment has been given, and on surveillance activities in
general. In the case of formal decisions concerning equipment classes and essential
requirements under Article 3(3), the Commission must obtain the formal opinion of
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the TCAM. Many TCAM documents are made publicly available after the meetings:
http://forum.europa.eu.int/Public/irc/enterprise/tcam/home
(follow “library” > “public documents”).
- 36/37 -
ANNEX 2 — Acronyms and abbreviations

CEN European Committee for Standardisation
CENELEC European Committee for Electrotechnical Standardisation
CEPT European Conference of Postal and Telecommunications
Administrations
DoC EC Declaration of Conformity
EEA European Economic Area
EMC Electromagnetic Compatibility
EMCD Electromagnetic Compatibility Directive
ERO European Radiocommunications Office
(permanent office of CEPT)
ETSI European Telecommunications Standards Institute
EU European Union
IEC International Electrotechnical Commission
ISO International Organisation for Standardisation
ITU International Telecommunication Union
MRA Mutual Recognition Agreement
NB Notified body
OJEU Official Journal of the European Union
RED Radio equipment directive
REDCA (see Annex 1)
ADCO RED (see Annex 1)
RF Radio frequency
TCAM (see Annex 1)
RSC (see Annex 1)
TGN Technical Guidance Note
- 37/37 -

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DRAFT RE Guide - Version of 19th March 2015

DRAFT Guide to the RE Directive 2014/53/EU

Version of 22nd May 2015

5.11.4 Other markings..................................................................................... 23

ANNEX 1 — Organisations and committees involved ............................................... 34

ANNEX 2 — Acronyms and abbreviations................................................................. 37

Open questions (to be solved somewhere in the RED Guide)

3. How should frequency band(s) be indicated according article 10.8 ?

1.1.3.2 Maritime equipment

1.1.4 Special measures regarding radio equipment at trade fairs, etc.

1.2 Defining “radio equipment”

determination; (2) ‘radio communication’ means communication by means of radio

1.5 Test equipment (transmitting radio frequencies)

1.7 Programmable equipment

1.9 Construction kits

1.10 Products for own use

1.11 Fixed installations

“Additional radio equipment for fixed installations” is understood to mean radio

1.12 Comparaison R&TTED – RED

1.13 Transitional provisions

1.15 Products newly covered by RED

1.16 Products not any more covered by RED

2 Obligations of the economic operators

The manufacturer must:

– the following informal statement on compliance with the Directive is made

2.3 Authorised representative

3.2 Essential requirements applicable to all radio equipment

3.3 Essential requirements applicable to certain type of radio equipment

- radio equipment interworks with accessories, in particular with common

4.1 Software defined radio

4.2 Registration of radio equipment types within some categories

5 INTERFACE REGULATIONS & SPECIFICATIONS

5.1 Notification of radio interface specifications

5.2 Assignment of radio equipment classes

5.3 HARMONISED STANDARDS

5.4 CONFORMITY ASSESSMENT PROCEDURES

5.6 Applicable conformity assessment procedures

5.6.3 EU-type examination followed by the conformity to type based on internal

5.8 Documentation required by the conformity assessment procedures

5.8.2 EC Declaration of Conformity

5.9.3 Identification number of the notified body

5.9.5 Marking of radio equipment containing an R&TTE component

6.2 Information for the user

7.2 General concept

Control of the spectrum remains essentially a national matter and so it is essential to

- Notified body number.

Furthermore REDCA provides Reference documents for its member containing

8 Market surveillance and enforcement

If the market surveillance authority of member state A finds a (presumed) non-

1. The manufacturer or his authorised representative established within the

time (usually 2 weeks). He has to take positive actions to make it actually

ANNEX 1 — Organisations and committees involved

ADCO RED (Group on ADministrative COoperation) is a group formed by the

CENELEC (European Committee for Electrotechnical Standardisation) is recognised

ERO (European Radiocommunications Office) is the permanent office supporting the

ETSI is recognised as an official European standards organisation by the European

ICNIRP (International Commission on Non-Ionising Radiation Protection) has no

REDCA (Radio Equipment Directive Compliance Association) provides a forum for