The European Radio Equipment Directive 2014/53/EU

Transcription

1 TÜV SÜD Slide 1 The European Radio Equipment Directive 2014/53/EU 28 March 2017

2 Meet the speaker behind the voice Jon Lea Senior Engineer (Product Certification), TÜV SÜD 30 years experience in the testing and certification industry 12 years working for a manufacturers compliance group ISO laboratory expertise including SAR Speaker s image R&TTE-D and RED Senior Technical Certifier Full Quality Assurance management and audit expert ISO 9001:2015 Lead Auditor Slide 2

3 RED webinar 1 Introduction 2 Radio Equipment Directive (RED) 2014/53/EU.a reminder 3 RED Technical Documentation including risk assessments 4 Notified Body obligations and RED Annex III and Annex IV 5 RED Harmonised Standard developments and some key points Slide 3

4 Introduction This Webinar is to remind attendees of the basic concepts of the Radio Equipment Directive 2014/53/EU and routes to compliance, but also cover the fundamentals for people who have limited knowledge of the requirements. The Webinar provides guidance to manufacturers on the Radio Equipment Directive Technical Documentation requirements, the notified body obligations and Type Examinations and finally explains some of the current problems with the harmonised standard development and release. It is not the intentions of the Webinar to quote text from the Radio Equipment Directive itself but show where to find this information and highlight specific issues unique to the new directives and RED. Slide 4

5 RED webinar 1 Introduction 2 Radio Equipment Directive (RED) 2014/53/EU.a reminder 3 RED Technical Documentation including risk assessments 4 Notified Body obligations and RED Annex III and Annex IV 5 RED Harmonised Standard developments and some key points Slide 5

6 Radio Equipment Directive 2014/53/EU.a reminder The Radio Equipment Directive (RED) was agreed 16th April 2014 and came into effect 13th June Replaces the Radio Equipment and Telecommunications Terminal Equipment (R&TTE) Directive which ceases to be valid 13th June Slide 6

7 Radio Equipment Directive 2014/53/EU.a reminder Scope The scope of the RED is different to the R&TTE Directive. Includes all radio equipment which intentionally emit and/or receives radio waves Sound and television broadcast receivers, radio determination equipment and radio equipment operating below 9 khz are all under the scope of the RED However telecommunications terminal equipment such as wire line PSTN telephones which were included in the R&TTE directive are not included in the RED Slide 7

8 Radio Equipment Directive 2014/53/EU.a reminder OJs HS R&TTED EMCD LVD OJs HS 1 R&TTED RED EMCD LVD OJs HS 1 RED EMCD LVD R&TTED (1999/5/EC) R&TTED RED transposition RED (2014/53/EU) EMCD (2004/108/EC) New EMCD (2014/30/EU) LVD (2006/95/EC) New LVD (2014/35/EU) May 2014 April 2016 June 2016 June 2017 Only R&TTED DoC valid R&TTED/EMCD/LVD (as applicable) and RED DoCs valid Only RED DoC valid Courtesy of the draft Radio Equipment Directive Guide Slide 8

9 Radio Equipment Directive 2014/53/EU.a reminder Radio Equipment R&TTE D (1999/5/EC) Or Broadcast radio receivers and radio operating below 9 khz Old EMCD and LVD RED (2014/53/EU) New EMCD (2014/30/EU) & New LVD (2014/35/EU) Or RED (2014/53/EU) RED (2014/53/EU) only Wired telecom terminal equipment R&TTE D (1999/5/EC) New EMCD (2014/30/EU) & New LVD (2014/35/EU) 20th April th June th June 2017 TÜV SÜD 3/21/2017 RED webinar Slide 9

10 Radio Equipment Directive 2014/53/EU.a reminder Essential Requirements As with the R&TTE directive, compliance is with a set of essential requirements: Article 3.1(a) Health and safety (RED also includes domestic animals and the protection of property ) Article 3.1(b) EMC Article 3.2 Radio (RED also includes the efficient use of radio spectrum ) Article 3.3 additional requirements when invoked by the European Commission Compliance is against Essential Requirements, not standards. However, compliance with appropriate Harmonised Standards published in the European Union Official Journal give an automatic presumption of conformity with the appropriate Essential Requirements. The Essential Requirements apply even in the absence of harmonised standards. New harmonised standards were required because: The scope of the RED is different. There are differences to the R&TTE directive essential requirements, particularly Article 3.2, resulting in additional considerations for receiver performance testing Slide 10

11 Radio Equipment Directive 2014/53/EU.a reminder Conformity Assessment Procedures (RED Article 17) Annex II Internal Production Control no Notified Body involvement, a self declaration procedure Annex III EU Type Examination and Conformity to Type based on Internal Production Control - Notified Body involvement to assess the technical documentation Annex IV Full Quality Assurance - Notified Body involvement to assess design, manufacturing, inspection and test processes Slide 11

12 Radio Equipment Directive 2014/53/EU.a reminder Conformity Assessment Procedures (routes to compliance) Article 3.1 (a) Health & Safety and Article 3.1(b) EMC Article 3.2 Radio and Article 3.3 (using harmonised standards) Article 3.2 Radio and Article 3.3 (not using or partial use of harmonised standards) Annex II Internal Production Control Annex III EU Type Examination + Conformity to Type based on Internal Production Control Annex IV Full Quality Assurance Slide 12

13 Radio Equipment Directive 2014/53/EU.a reminder Placing on the market includes first making available on the market Manufacturer or Importer placing on the market making available on the market End User Distributor A Distributor B Each individual radio equipment made available on the market must comply with the RED at the moment of placing on the market. After 13 th June 2017 All Radio Equipment must be compliant with the RED and may no longer be placed on the Market using the R&TTE. Slide 13

14 Radio Equipment Directive 2014/53/EU.a reminder Economic Operators The RED has specific obligations for Economic Operators: Manufacturers (both inside and outside Europe) Article 10 Authorised Representative (in Europe) Article 11 Importers (in Europe) Article 12 Distributors (in Europe) Article 13 All Economic Operators have specific obligations for market surveillance authorities. Slide 14

15 Radio Equipment Directive 2014/53/EU.a reminder Combined Equipment The presence of an inbuilt radio module or component makes the whole product radio equipment. Combined equipment is radio equipment ETSI Guide EG V1.1.1 ( ) provides guidance for multi-radio and combined radio and non-radio equipment Blue Guide The Blue Guide on the implementation of EU products rules 2016, now cited in the European Union Official Journal is a fundamental supporting document. The majority of questions about placing a radio product on the market can be answered by referencing the RED and Blue Guide. RED Guide An RED Guide is being produced (currently still in draft format) which will provide additional support for economic operators and notified bodies to be used in conjunction with the RED and Blue Guide. Slide 15

16 RED webinar 1 Introduction 2 Radio Equipment Directive (RED) 2014/53/EU.a reminder 3 RED Technical Documentation including risk assessments 4 Notified Body obligations and RED Annex III and Annex IV 5 RED Harmonised Standard developments and some key points Slide 16

17 RED Technical Documentation Technical Documentation requirements are similar for Annex II, III and IV of the RED, i.e. a compiled set of technical documentation and a technical justification for compliance with the essential requirements of the RED. The Technical Documentation fundamental content requirements are explained in RED Article 21 and Annex V, but the directive itself also requires additional documentation (for example the risk assessment). Slide 17

18 RED Technical Documentation The Technical Documentation requirements are similar to the R&TTE Directive Technical Construction File (TCF) requirements, but differences to consider include Intended purpose (for all essential requirements) Reasonably foreseeable use (for Article 3.1a Health and Safety) A Risk analysis and assessment (linked to the compliance strategy of the product) Changes to the user information requirements Changes to the Labelling requirements Changes to the DoC format Article 10(2) operated in at least one Member State Article 10(10) - restrictions on putting into service (packaging and user guide) Slide 18

19 RED Technical Documentation Risk Analysis and Assessment and Compliance Strategy RED Risk Analysis is a fundamental part of the RED technical documentation and compliance strategy of the product as well as a fundamental aspect of all the new directives. Risk does not just relate to Health & Safety for the RED A determination of the risk to non-compliance with all of the essential requirements for the intended use, and, in addition, for Article 3.1(a), for the reasonably foreseeable use is required. [References RED Annex III Module B 3(c) and Article 17(1)] The Blue Guide is the main starting reference for a risk assessment and has the text - In risk related harmonisation legislation this means in particular that a manufacturer always, even when using harmonised standards, remains fully responsible for assessing all the risks of his product in order to determine which essential (or other) requirements are applicable [Reference - Blue Guide ( Role of harmonised standards )] Slide 19

20 RED Technical Documentation Risk Analysis and Assessment and Compliance Strategy Blue Guide risk analysis Courtesy of The Blue Guide Slide 20

21 RED Technical Documentation Risk Analysis and Assessment and Compliance Strategy The risk assessment documents how the risks are addressed (mitigated) to ensure that the product complies with the essential requirements, including the identification of harmonised standards referenced in the Official Journal and other standards as required. The risk assessment needs to include information for example for the use of nonharmonised standards and other additional guidance which then falls outside the scope of using Official Journal listed harmonised standards that provide a presumption of conformity. There are a number of publically available documents to support manufactures in the production of a risk assessments from the European Commission, ADCO and CENELEC. For example CENELEC Guide 32 could be used to help in compiling the risk analysis, noting that this is only for Article 3.1a safety. Slide 21

22 RED Technical Documentation User Information (user guide / instructions / safety information) key points to consider for the RED Intended Purpose Instructions on how to use the equipment Description of accessories and components, including software, to allow equipment to operate as intended For transmitting equipment, Frequency bands and the maximum RF power transmitted in those bands (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. Declaration of Conformity (DoC) Either a Full EU DoC or where the product will only include a simplified EU DoC it must contain the exact internet address where the full text of the EU DoC can be obtained. Any Compliance related Installation Instructions Restrictions on putting into service (i.e. Article 10(10) plus implementing acts) [Reference RED Article 10(8)] Slide 22

23 RED Technical Documentation Labelling (key points to consider for the RED) The manufacturer is still required to follow the CE marking requirements of Regulation (EC) No 765/2008. The notified body number after the CE mark is only applied to products following the Annex IV FQA route to compliance. The class 2 identifier alert sign, required by the R&TTE Directive, is not required by the RED and is replaced by the requirements in accordance with Article 10(10) of the RED. The label should include a type, batch or serial number or other element allowing its identification The label needs to have the manufacturers name, registered trade name or registered trade mark and the postal address at which they can be contacted Note - There is additional text for the postal address where the size or nature of radio equipment does not allow it, on its packaging, or in a document accompanying the radio equipment Electronic Marking (e-marking, onscreen marking) is currently not allowed for the RED [References RED Articles 10(6), 10(7), 19 and 20, Recital 47 and Article 47] Slide 23

24 RED Technical Documentation RED Declaration of Conformity (DoC) The RED DoC requirements in Annex VI are similar to an R&TTE DoC (for example explaining the product type, manufacturers address, compliance statement, signed and dated etc), but has specific additional items to consider - References to the relevant standards to which conformity is declared, including identification number and version and, where applicable, date of issue (i.e. the listing of version and / or dates is mandatory) Where applicable, the Notified Body (name, number) performed (description of intervention) and issued the EU-type examination certificate (i.e. you need to have the EU-type examination certificate number on the DoC for an Annex III type examination.) Where applicable, description of accessories and components, including software Slide 24

25 RED Technical Documentation RED Article 10(2) and 10(10) The RED manufacturers obligations include the following (an explanation of compliance to which needs to be covered in the technical documentation) Article 10(2) The radio equipment being capable of compliant operation in at least one Member State. and Article 10(10) Where there are restrictions on use or requirements for authorisation for use, information is required on the packaging to identify the Member States or area within a Member State where there are restrictions. The information must be fully explained in the user instructions. Note A Commission Implementing Regulation is being produced for guidance which is currently in draft format which requires a pictogram on the packaging. Compliance to Article 10(10) is required regardless of the status of the Implementing Regulation. [References RED Articles 10(2), 10(10), Annex V (i)] Slide 25

26 RED webinar 1 Introduction 2 Radio Equipment Directive (RED) 2014/53/EU.a reminder 3 RED Technical Documentation including risk assessments 4 Notified Body obligations and RED Annex III and Annex IV 5 RED Harmonised Standard developments and some key points Slide 26

27 Annex III Module B EU Type Examination + Conformity to Type based on Internal Production Control Annex III Module B Type Examination requires the use of notified body. The manufacturer submits an application to a single notified body of his choice. The notified body creates an evaluation report the contents of which will only be released with the agreement of the manufacturer. Where the type meets the requirements of the RED that apply to the radio equipment concerned, the notified body issues an EU-type examination certificate to the manufacturer. Note this is type compliance of the product to the entire RED not just for example the essential requirements. The manufacturer is required to inform the notified body of all modifications to the approved type that may affect the conformity of the radio equipment with the essential requirements of this Directive or the conditions for validity of that certificate. [References RED Annex III 5, 6 and 7] Slide 27

28 Annex III Notified Body Obligations Notified Bodies have obligations - To maintain knowledge of the state of the Art and notify Type Examination certificate holders of changes which may affect their product s compliance with the RED. To inform the notifying authority of Type Examination certificates issued (including modifications) or withdrawn; and make available certificates (including modification) refused, suspended or restricted. To inform the other notified bodies of Type Examination certificates (including modifications) which have been refused, withdrawn, suspended or restricted, and, upon request, certificates (including modifications) issued. To inform the Member States of Type Examination certificates issued (including modifications) in those cases where harmonised standards the references of which have been published in the Official Journal of the European Union have not been applied or not been fully applied. [References RED Annex III 7 and 8] Slide 28

29 Annex IV Full Quality Assurance (FQA) FQA Approval is an approval of the manufacturer s processes which permits the application of the CE mark and notified body number to products within the scope of the FQA. The manufacturer submits an FQA application to a single notified body of his choice. The notified body assesses the quality system by periodic audits to determine whether it satisfies the requirements of Annex IV of the Directive. Design audits include assessment of product technical compliance documentation to verify the ability to identify applicable requirements and to carry out product assessments. Quality systems based upon ISO 9000 and test facilities operating to ISO inherently meet many, but not all of the requirements for FQA Approval under the Directive. However there needs to be consideration for the transitioning of ISO 9001:2008 to ISO 9001:2015 as well. Slide 29

30 Annex IV Notified Body Obligations Notified Bodies have obligations - To inform the notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. Similarly - To inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. [Reference RED Annex IV 7] Slide 30

31 RED webinar 1 Introduction 2 Radio Equipment Directive (RED) 2014/53/EU.a reminder 3 RED Technical Documentation including risk assessments 4 Notified Body obligations 5 RED Harmonised Standard developments and some key points Slide 31

32 Harmonised Standards (key points) The European Commission implementing decision document M/536 issued 4th August 2015 was a standardisation request to ETSI and CENELEC to create RED harmonised standards for all of the essential requirements. M/536 included specific requests to the standards organisation for example to include an explanation of the relationship of the standards content to the essential requirements. There were new specifications (i.e. for broadcast receiver products) required. The majority of R&TTE specification are in the process or have been updated for the RED due to the changes in the essential requirements (i.e. for Article 3.2 for the efficient use of radio spectrum ). The European Commission review published specifications before citation in the RED Official Journal of harmonised standards. Issued standards may require further rework by the standards organisation based on comments from the European Commission. TÜV SÜD 3/21/2017 RED webinar Slide 32

33 Harmonised Standards (key points) Article 3.1a (Health and Safety) SAR / RF exposure standards are in the process of being updated for the RED (but are currently not in the RED Official Journal), for example EN 50360:2017 (Head SAR) EN 50566:2017 (Body SAR) The Commission Implementing Decision (EU) 2016/537, dated 5 April 2016 on EN 50566:2013 body SAR a separation distance of not more than a few millimetres may be used 5mm body SAR separation although for the R&TTE directive should be used for any current submissions. Some safety specifications are also being updated for the RED, (but are currently not in the RED Official Journal), for example EN (Audio/video, information and communication technology equipment) EN (Equipment to be installed outdoors) TÜV SÜD 3/21/2017 RED webinar Slide 33

34 Harmonised Standards (key points) Article 3.1b (EMC) The majority of the EMC requirements can still be found under the R&TTE EMC EN X series of specifications and are in the process of being updated. New Article 3.1b specifications outside the EN X series include - EN (Combined equipment, commercial and light industry locations) EN (Combined equipment, industrial locations) Some existing R&TTE Article 3.1b EMC specifications have been merged for the RED, for example EN (merge of R&TTE EN and -24 for mobile phones) A key change is that radiated immunity testing is now required to 6 GHz. Care is also needed with the radiated immunity exclusion ranges which have also changed in some cases particularly for the receive band. The European Commission has recently made comments on a large number of the EN X series specifications which are being reworked. TÜV SÜD 3/21/2017 RED webinar Slide 34

35 Harmonised Standards (key points) Article 3.2 (RF) A number of the Article 3.2 specifications are being created as a two stage process, with a further version being created with for example additional receiver performance requirements. There are new Article 3.2 specifications for the RED, for example EN (TV Broadcast Receivers) EN (Broadcast Sound Receivers including FM and DAB) A number of the specification keep the same specification number, but a new version has been created for the RED, for example EN (2.4 GHz Wideband transmission systems) EN (5 GHz RLAN, Radio Local Area Network) Some new product specific specifications have been created for existing radio items under the scope of both the R&TTE directive and RED, for example - EN (GNSS, Global Navigation Satellite System, e.g. GPS) EN (Wireless power transmission) TÜV SÜD 3/21/2017 RED webinar Slide 35

36 Harmonised Standards (key points) The RED Official Journal of harmonised standards is now being updated monthly. A number of the specifications may not be published in the RED Official Journal before 13 th June This includes for example EN for Audio Broadcast receivers, EN for 5 GHz RLAN devices and EN for GNSS The absence of a harmonised standard does not mean do nothing as you still need to demonstrate compliance to the essential requirements which for Article 3.2 will require notified body intervention. The absence of harmonised standards may mean consideration for the use of ETSI guide EG V1.1.1 for Articles 3.1b and 3.2, but understanding this is a guide and should not for example be included on a Declaration of Conformity. TÜV SÜD 3/21/2017 RED webinar Slide 36

37 RED key points to remember Draft and alternative specifications can be used to provide evidence of compliance, but this should be considered in the risk assessment as they do not provide a presumption of conformity. However if a manufacturer has decided to not use an RED Official Journal published standard the notified body involved needs to inform all member states of this deviation. EMC and Low voltage directive OJ listed specifications do not provide presumption of conformity for the RED. This is also a specific difference between the R&TTE and RED Official Journal wording. EMC and Low Voltage directive OJ listed specifications can be used towards evidence of compliance but this should be considered in the risk assessment. If available you should always try to use the RED Official Journal listed product specific specification. TÜV SÜD 3/21/2017 RED webinar Slide 37

38 RED key points to remember Manufacturers, test houses and notified bodies need to take great care with specification changes (for new RED specifications and version changes) as they can be considerably more complicated than initially thought. An issued specification from a standards organisation can still potentially require further revision before publication in the RED official journal. The Annex III notified body type examination certificate number needs to go onto the manufacturers declaration of conformity. TÜV SÜD 3/21/2017 RED webinar Slide 38

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40 Thank you! TÜV SÜD 3/21/2017 TÜV SÜD RED webinar Slide 40