radio equipment directive 2014/53/eu...radio equipment directive (red) 2014/53/eu 16/04/2014 :...
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AGORIA, THE TECHNOLOGYAGORIA, THE TECHNOLOGYAGORIA, THE TECHNOLOGYAGORIA, THE TECHNOLOGY
INDUSTRY IN BELGIUMINDUSTRY IN BELGIUMINDUSTRY IN BELGIUMINDUSTRY IN BELGIUM
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Building, Contracting & Technical Services industries
Manufacturing industries
Aeronautics, Space, Security & Defence industries
Digital industries
Materials industries
Organisation of technology inspired companies in
Belgium
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1,900Member companies
in 6 industries
Telecom industries
81%SMEs
Driving our economy
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Size of Agoria member companies
300,000people
are employed in the technology industry
19%>100 EMP.24%
<10 EMP.
57%10 - 100 EMP.
RADIO EQUIPMENT DIRECTIVERADIO EQUIPMENT DIRECTIVERADIO EQUIPMENT DIRECTIVERADIO EQUIPMENT DIRECTIVE
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� Radio Equipment Directive (RED) 2014/53/EU
� 16/04/2014 : Publication in Official Journal
� 12/06/2016 : Transposition national law
� 13/06/2016 : Application RED provisions and repeal R&TTE Directive 1999/5/EC
� Transitionalprovisionsup to 12/06/2017
Radio Equipment Directive
� “radio equipment” : electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communicationand/or radiodetermination, or an electrical or electronicproduct 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 communicationand/or radiodetermination
� “radio communication” : communicationby means of radio waves
� “radio determination” : determination of the position, velocity and/or other characteristics of an object, or the obtaining of information relating to those parameters, by means of the propagation properties of radio waves
� “radio waves” : electromagnetic waves of frequencies lower than 3 000 GHz, propagated in spacewithout artificial guide
Scope -Definitions
� Radio equipment exclusively used for activities concerning public security , defence
� Radio equipment used by radio amateurs
� Marine equipment (Directive 96/98/EC)
� Airborne products (Regulation 216/2008)
� Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes
Scope - Exclusions
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� Conclusion : Many products, regardless of their primary function, are under the scope
of Radio Equipment Directive
� e.g. anything with a GPS, Bluetooth, RFID, RLAN, WiFi, NFC, ….
Scope
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� Products can be covered by more than one Union harmonisation act. If one or more of
these acts do not exclude the application of the other Union harmonisation
legislation, then all relevant legislation apply simultaneously.
� When RED applies, LVD 2014/35/EU and EMCD 2014/30/EU do not apply !
Other applicable EU legislation
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� Art. 3.1(a) : Protection of health and safety of persons and of domestic animals and theprotection of property, including the objectives with respect to safety requirements set out in Directive 2014/35/EU (LVD), but with no voltage limit applying
� Art. 3.1(b) : An adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU (EMCD)
� Art. 3.2 : Effective use and support of efficient use of radio spectrum in order to avoidharmful interference
� Art. 3.3 : Essential requirements, applicable where decided by the European Commission bymeans of delegated acts
Essential requirements
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� Interworking with accessories (common chargers) ����under study
� Interworking via networks with other radio equipment
� Connection to interfaces of the appropriate type
� No harm to the network
� Protection of personal data and privacy of the user ����under study
� Protection from fraud����under study
� Access to emergency services ����published (see next slide)
� Use by users with a disability
� Radio equipment supports certain features in order to ensure that software can only beloaded into the radio equipment where the compliance of the combination of the radio equipment and the software has been demonstrated����under study
Essential requirements–art. 3.3
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� Delegated acts on access to emergency services (Art. 3.3.g)
� 2000/637/EC : Radio equipment covered by the regional arrangement concerning the
radiotelephone service on inland waterways
� 2001/148/EC : Avalanche beacons
� 2005/53/EC : Radio equipment intended to participate in the Automatic Identification System (AIS)
� 2005/631/EC : Access of Cospas-Sarsat locator beacons to emergency services
� 2013/638/EU : Marine radio communication equipment which is intended to be used on non-SOLAS
vessels and to participate in the Global Maritime Distress and Safety System (GMDSS)
� (EU)2019/320 : Caller location in emergency communications from mobile devices
� Mandatory application : March 2022
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Essential requirements–art. 3.3
� Options to prove compliance with essential requirements
� Internal production control (Module A)
� EU-type examination & conformity to type based on internal production control (Module B & C)
� Notified body involvement
� Conformitybased on full quality assurance (Module H)
� Notified body involvement
� Note : CE marking followed by identification number of notified body
� CE marking shall be affixed on the radio equipment and on the packaging
Conformity assessment procedures
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Conformity assessment procedures
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Art 3.1(a) Health & safety
Art 3.1(b) EMC
Art 3.2 Spectrum, art 3.3
Use of harmonised
standards
Art 3.2 Spectrum, art 3.3
No or partial use of
harmonised standards
Annex II (module A)Internal production control
Annex III (modules B+C)EU-type examination and
Conformity to type based on
internal production control
Annex IV (module H)Conformity based on full
quality assurance
� General description of the radio equipment including� Photographs or illustrations
� Versions of software or firmware affecting compliance of the device
� User information and installation instructions
� Conceptual design and manufacturing drawings and schemas
� Description and explanations to understand the drawings and schemas
� List of harmonised standards applied in full or in part. Where those harmonised standards have notbeen applied, description of the solutions adopted to meet the essential requirements.
� Copy of the declaration of conformity
� EU type examination certificate (where conformity assessment according to Annex III has been applied)
� Results of design calculations made, examinations carried out, etc.
� Test reports
� An explanation of the compliance with the requirements of Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10)
Technical documentation
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� Identification of object of the declaration
� Name and addressof the manufacturer or his authorised representative
� Statement “This declaration is issued under the sole responsibility of the manufacturer”
� Statement “The object of the declaration described above is in conformity with the relevant Union harmonisation legislation : Directive 2014/53/EU (incl. other Directives as applicable)
� Reference to the relevant harmonised standards used or references to other technicalspecifications in relation to which conformity is declared
� Details of the notified body (name, number) and a description of the assessment theyundertook, and the reference of the resulting EU-type examination certificate
� Description of accessories and software which allow the equipment to function as intended
� Signature and date
EU declaration of conformity
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� “manufacturer” : any natural or legal person who manufacturers radio equipment or has radio equipment designed or manufactured, and markets that equipment under his name or trade mark
� “authorised representative” : any natural or legal person established within the Union whohas received a written mandate from a manufacturer to act on his behalf in relation tospecified tasks
� “importer” : any natural or legal person established within the Union who places radio equipment from a third country on the Union market
� “distributor” : any natural or legal person in the supply chain, other than the manufactureror the importer, who makes radio equipment available on the market
Economic operators -Definitions
� Designed and manufactured in accordance with essential requirements
� Ensure that radio equipment can be operated in at least one Member State without
infringing applicable requirements on the use of radio spectrum
� Draw up the technicaldocumentation and carry out the relevant conformity
assessment procedure, draw up EU declaration of conformity and affix the CE marking
� Keep technicaldocumentation and EU declaration of conformity for 10 years after the
radio equipment has been placed on the market
� Procedures are in place for series production to remain in conformity. Changes in
design or characteristics and changes in harmonised standards shall be adequately
taken into account
Obligations of manufacturers
� Radio equipment bears a type, batch or serial number or other element allowing itsidentification
� Name, registered trade name or registered trade mark, and the postal address at whichthey can be contactedshall be indicated on the radio equipment
� Radio equipment is accompanied by instructions and safety information in a languagewhich can be easily understood by consumersand other end-users
� For transmitters the information shall include the frequency bands in which it operates and themaximum radio-frequency power transmitted in the frequency bands
� Radio equipment is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity. Simplified EU declaration of conformity containsthe exact internet address where the full text of the EU declaration of conformity can beobtained
Obligations of manufacturers
� Information on the packaging shall allow the identification of the Member States or
the geographical area within a Member State where restrictions on putting into
service or requirements for authorisation of use exist. Such information shall be
completed in the instructions accompanying the radio equipment
� Take corrective measures to bring radio equipment into conformity, to withdraw it or
to recall it in case of reasons to believe that radio equipment which they have placed
on the market is not in conformity
� Provide to competent national authorities all information to demonstrate the
conformity of the radio equipment. Cooperate with authorities to eliminate risks
posed by radio equipment which they have placed on the market
Obligations of manufacturers
� Manufacturer may, by a written mandate, appoint an authorised representative
� Perform the tasks specified in the mandate, which allows at least the following :
� Keep EU declaration of conformity and technical documentation at the disposal of national market surveillance authorities for 10 years after the radio equipment has been placed on the market
� Further to reasoned request from a competent national authority, provide them with all the information and documentation necessary to demonstrate the conformity of radio equipment
� Cooperate with the competent national authorities, at their request, on any action taken to elimate therisks posed by radio equipment
� Some manufacturer’s obligations shall not form part of the mandate :
� Design and manufacture in accordance with essential requirements
� Draw up technical documentation
Authorised representatives
� Place only compliant radio equipment on the market
� Ensure that the manufacurer has carried out the appropriate conformity assessment and
that the radio equipment can be operated in at least one Member State without infringing
applicable requirements on the use of radio spectrum
� Ensure that the manufacturer has drawn up the technical documentation, that the radio
equipment bears the CE marking and is accompanied by the required information and
documents and that the manufacturer has complied with the traceability requirements
� Importers shall indicate on the radio equipment their name, registered trade name or
registered trade mark and the postal addressat which they can be contacted or, where that
is not possible, on its packaging or in a document accompanying the radio equipment
Obligations of importers
� Ensure that radio equipment is accompanied by instructions and safety information in
a language which can be easily understood by consumers and other end-users
� Ensure that, while radio equipment is under their responsibility, its storage or
transport conditions do not jeopardise its compliance with the essential requirements
� Where deemed appropriate with regard to the risks presented by radio equipment,
importers shall carry out sample testing of radio equipment made available on the
market, investigate, and, if necessary, keep a register of complaints, of non-
conforming radio equipment and radio equipment recalls, and shall keep distributors
informed of any such monitoring
Obligations of importers
� Take corrective measures to bring radio equipment into conformity, to withdraw it or
to recall it in case of reasons to believe that radio equipment which they have placed
on the market is not in conformity
� Keep a copy of the EU declaration of conformity at the disposal of the market
surveillance authorities and ensure that the technical documentation can be made
available to those authorites
� Provide to competent national authorities all information to demonstrate the
conformity of the radio equipment. Cooperate with authorities to eliminate risks
posed by radio equipment which they have placed on the market
Obligations of importers
� Act with due care in relation to the requirements
� Verify that radio equipment bears CE marking, and is accompanied by
documents/information required and by instructions and safety information in a
language which can be easily understood by consumers an other end-users in the
Member State in which the radio equipment is to be made available onthe market.
Verify that the manufacturer and the importer have complied with the tracability
requirements, information on geographical restrictions, …
� Ensure that, while radio equipment is under their responsibility, its storage or
transport conditions do not jeopardise its compliance with the essential requirements
Obligations of distributors
� Ensure corrective measures are taken to bring radio equipment into conformity, to
withdraw it or to recall it in case of reasons to believe that radio equipment which they
have made available on the market is not in conformity
� Provide to competent national authorities all information to demonstrate the
conformity of the radio equipment. Cooperate with authorities to eliminate risks
posed by radio equipment which they made available on the market
Obligations of distributors
� Commission Implementation Regulation 2017/1354 specifying how to represent the information provided for in art. 10(10) of RED
� Art. 10(10) : In case of restrictions on putting into service or of requirements for autorisation of use, information on the packaging shall allow the identification of the Member States where these exist
� Options
� Pictogram, below or next to the sign the abbreviations of the Member States
� ‘Restrictions or Requirements in ‘ followed by abbreviations of the Member States
� Mandatory application : 9 August 2018
Art. 10(10) : implementing act
� Radio Equipment Directive 2014/53/EU
� Implementing Regulation RED art. 10(10) 2017/1354
� EC Guide to the Radio Equipment Directive
� EC Supplementary guidance LVD/EMCD/RED
� RED harmonised standards
� ECO Frequency Information System
� Commission Decision Short Range Devices
� NANDO – Notified Bodies Database
� FCC ID Search
� ETSI EG 203 367 (combined equipment)
� REDCA TGN 01 (integration radio modules)
� Blue Guide on the implementation of EU product rules (2016)
� Agoria white paper CE marking (NL) (FR)
� Agoria CE Marking Tool
Useful links
