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Radio Equipment Directive (RED) 2014/53/EUCurrent status legal framework and evolutions

29 May 2019

Marc Cumpsmarc.cumps@agoria.be

RED - Timing

Source : European Commission

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“radio equipment” means electrical or electronic product, whichintentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, 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 thepurpose of radio communication and/or radiodetermination

Exclusions : marine equipment, airborne equipment, custom built evaluation kits

RED - Scope

RED applicable to the combination of radio equipment and non-radio equipment as a whole only if the radio equipment is

incorporated into the non-radio product, and permanently affixed to the non-radio product

RED - Scope

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RED - Scope

without wireless moduleMD 2006/42/ECEMCD 2014/30/EU

RED - Scope

with wireless moduleMD 2006/42/ECRED 2014/53/EU

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RED - Scope

without wireless moduleLVD 2014/35/EUEMCD 2014/30/EURoHS 2011/65/EUErP (EC)1275/2008

RED - Scope

with wireless moduleRED 2014/53/EURoHS 2011/65/EUErP (EC)1275/2008

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Art. 3.1(a) Health and safety Art. 3.1(b) Electromagnetic compatibility Art. 3.2 Effective and efficient spectrum use Art. 3.3 Additional requirements (in case of delegated acts)

RED - Essential requirements

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Interworking with accessoriesunder 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 fraudunder 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

be loaded into the radio equipment where the compliance of the combination of theradio equipment and the software has been demonstratedunder study

RED - Essential requirements (Art. 3.3)

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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 devices11

RED - Essential requirements (Art. 3.3)

Annex II Internal production control Annex III EU type examination and conformity to type based

on internal production control Annex IV Full quality assurance

RED - Conformity Assessment Procedures

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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

Conformity based 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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RED - Conformity Assessment Procedures

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Art 3.1(a) Health & safetyArt 3.1(b) EMC

Art 3.2 Spectrum, art 3.3Use of harmonised

standards

Art 3.2 Spectrum, art 3.3No 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

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General description of the radio equipment incl. 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. Copy of the declaration of conformity EU type examination certificate (in case of conformity assessment according to Annex III) 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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General description of the radio equipment incl. 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. Copy of the declaration of conformity EU type examination certificate (in case of conformity assessment according to Annex III) 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 address of 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 technical

specifications in relation to which conformity is declared Details of the notified body (name, number) and a description of the assessment they

undertook, 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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Provision of information on the compliance of combination of radio equipment andsoftware Manufacturers of radio equipment and of software allowing radio equipment to be used as intended shall

provide the Member States and the Commission with information on the compliance of intendedcombinations of radio equipment and software with the essential requirements

Such information shall result from a conformity assessment and shall be given in the form of a statement of compliance

Depending on the specific combinations of radio equipment and software, the information shall preciselyidentify the radio equipment and the software which has been assessed, and it shall be continuouslyupdated

European Commission to decide by means of delegated acts which categories or classes of radio equipment are concerned

Combination radio equipment - software

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As from 12 June 2018, manufacturers shall register radio equipment types withincategories of equipment affected by a low level of compliance with the essentialrequirements within a central database prior to radio equipment within thosecategories being placed on the market When registering such radio equipment types, manufacturers shall provide some, or where justified

all, elements of the technical documentation The Commission shall allocate to each registered radio equipment type a registration number, which

manufacturers shall affix on radio equipment placed on the market

European Commission to decide by means of delegated acts which categories of radio equipment are concerned and the elements of the technical documentation to beprovided

Registration of radio equipment

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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 theUnion who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks

“importer” : any natural or legal person established within the Union who placesradio equipment from a third country on the Union market

“distributor” : any natural or legal person in the supply chain, other than themanufacturer or the importer, who makes radio equipment available on themarket

Economic operators - Definitions

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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 technical documentation and carry out the relevant conformity

assessment procedure, draw up EU declaration of conformity and affix the CE marking

Keep technical documentation and EU declaration of conformity for 10 yearsafter 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 standardsshall be adequately taken into account

Obligations of manufacturers

Radio equipment bears an identification (e.g. type, batch, serial number, …) Name, registered trade name or registered trade mark, and postal address

shall be indicated on the radio equipment Accompanied by instructions and safety information in a language which can

be easily understood by consumers and other end-users Transmitters : frequency bands and maximum radio-frequency power

Radio equipment is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity.

Obligations of manufacturers

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Information on the packaging shall allow the identification of the Member Stateswhere restrictions on putting into service or requirements for authorisation of useexist. 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 placedon the market is not in conformity

Provide to competent national authorities all information to demonstrate theconformity of the radio equipment. Cooperate with authorities to eliminate risksposed by radio equipment which they have placed on the market

Obligations of manufacturers

Representation of information in accordance with Article 10(10) Mandatory application : 9 August 2018 Options

Pictogram ‘Restrictions or Requirements in’

Implementing Regulation (EU)2017/1354

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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 the

risks 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 infringingapplicable 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 anddocuments 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 address at which they can be contacted or, where thatis not possible, on its packaging or in a document accompanying the radio equipment

Obligations of importers

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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 themarket, investigate, and, if necessary, keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, and shall keep distributorsinformed 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 placedon 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 theconformity of the radio equipment. Cooperate with authorities to eliminate risksposed by radio equipment which they have placed on the market

Obligations of importers

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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 theMember State in which the radio equipment is to be made available onthe market. Verify that the manufacturer and the importer have complied with the tracabilityrequirements, 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, towithdraw it or to recall it in case of reasons to believe that radio equipment which theyhave made available on the market is not in conformity

Provide to competent national authorities all information to demonstrate theconformity of the radio equipment. Cooperate with authorities to eliminate risksposed by radio equipment which they made available on the market

Obligations of distributors

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Harmonised standards (Mandate M/536)

Standards

Orgalime guide combined equipment

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Harmonised standards

Brexit

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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

Blue Guide on the implementation of EU product rules (2016) Agoria white paper CE marking (NL) (FR) Agoria CE Marking Tool

Useful links

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Thank youFor your attention

“making available on the market” : any supply of radio equipment for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge

“placing on the market” : the first making available of radio equipment on the Union market

“putting into service” : the first use of radio equipment in the Union by its end-user

Other - Definitions

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Harmonised standards

http://www.efis.dk

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