Changes to the Electromagnetic Compatibility (EMC) Directive Presentation by Pete Dorey TÜV SÜD Product Service Slide 1
Contents 1 What is Electromagnetic Compatibility (EMC)? 2 EMC Directive Overview 3 New EMC Directive 2014/30/EU TÜV SÜD Product Service Slide 2
Problems at Home Television Interference Radio Interference Computer crashing Telephone/Telecom Interference TÜV SÜD Product Service Slide 3 3
Coupling Mechanisms far-field radiated conducted near-field induced (capacitive or inductive) TÜV SÜD Product Service Slide 4
Contents 1 Overview of Electromagnetic Compatibility (EMC)? 2 EMC Directive Overview 3 New EMC Directive 2014/30/EU TÜV SÜD Product Service Slide 5
EMC Directive 2004/108/EC EQUIPMENT APPARATUS FIXED INSTALLATIONS Any finished appliance or combination thereof A particular combination of apparatus used permanently at pre-defined locations The EMC Directive does NOT address safety. TÜV SÜD Product Service Slide 6 6
What is Apparatus? TÜV SÜD Product Service Slide 7 7
Includes Mobile installations Mobile installations are defined as a combination of apparatus (and where applicable other devices) intended to be moved and operated in a range of locations are deemed to be apparatus. All provisions of the EMC Directive, as defined for apparatus, apply to mobile installations. TÜV SÜD Product Service Slide 8 8
What is a Fixed Installation? TÜV SÜD Product Service Slide 9 9
EMC Directive Exclusions Equipment covered by Directive 1999/5/EC on Radio and telecommunications terminal equipment (R&TTE) Aeronautical products as referred to in Regulation (EC) No1592/2002 Radio equipment used by Radio Amateurs Benign equipment (e.g. passive, cables, switches etc.) Excluded components (e.g. discrete components, assemblies not intended for the end user) Equipment where essential requirements are laid down in other Directives; e.g: Marine Equipment Directive (MED) 96/98/EC Automotive & other Vehicle Directives Medical Device Directives Note: Military/Defence/Security equipment is not excluded TÜV SÜD Product Service Slide 10
EMC Essential Requirements Essential Requirements include the Protection Requirements such that Equipment shall be designed and manufactured to ensure that: the EM disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended; it has a level of immunity to the EM disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use TÜV SÜD Product Service Slide 11 11
Enforcement In the UK the EMC Directive is enforced by OFCOM and Trading Standards under the UK Regulations SI 2006 No 3418 The maximum penalty for the supply of non-compliant equipment is: Three months imprisonment and/or A 5000 fine More normally the manufacturer would be required to recall or replace any non-compliant apparatus. The enforcing authorities have the power to suspend or prohibit sale of apparatus for which they have reasonable evidence that it does not comply. TÜV SÜD Product Service Slide 12 12
Contents 1 Overview of Electromagnetic Compatibility (EMC)? 2 EMC Directive Overview 3 New EMC Directive 2014/30/EU TÜV SÜD Product Service Slide 13
New EMC Directive 2014/30/EU Title: Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the member states relating to electromagnetic compatibility A new EMC Guide will also be prepared to explain the details of the new EMC Directive 14
Reason for New EMC Directive Alignment with the New Legislative Framework (NLF) EU Decision 768/2008/EC Common Framework for the Marketing of Products EU Regulation EC 765/2008 - Regulation on Accreditation and Market Surveillance (known as RAMS) NLF objectives: Improved Market Surveillance unsafe and noncompliant products obligations on Authorities, Economic Operators Accreditation of Notified Bodies to improve quality of work Establish a common legal framework align conformity assessment procedures, definitions and clarification of CE marking rules EMC is one of the Directives being aligned 15
New EMC Directive Transitional Period 20 April 2014 20 April 2016 Current EMC Directive 2004/108/EC Apparatus can still be Placed on the market EMC Directive 2004/108/EC Repealed New EMC Directive 2014/30/EU Regulations published Transposition to new EMC Directive 2014/30/EU New DoCs for Apparatus must be issued 16
Scope Changes #1 Second Hand equipment must comply on first entry to the EU Does not apply to custom built evaluation kits for professionals used solely at research & development facilities Applies to distance selling e.g. Internet 17
Scope Changes #2 The new Radio Equipment Directive (RED) 2014/53/EU transposed 13 June 2016 has scope changes affecting EMC Directive: Broadcast receivers (TV, Radio, Scanner) move to RED from EMCD Telecom terminal equipment moves to EMCD from old R&TTE Transmitters operating <9kHz move from EMCD to RED (Tx not used in UK except amateur) 18
Who is affected? Economic Operators Manufacturers Authorised Representatives Importers Distributers Notified Bodies Enforcement Agencies 19
Traceability All Economic Operators must on request provide the Market Surveillance Authorities with records; Identity of Economic Operators who have supplied the product (e.g. manufacturer, importer) Identity of Economic Operators who have received the product (e.g. importer, distributor) Records must be held for 10 years Does not apply to (non-ce marked) apparatus for Fixed Installations TÜV SÜD Product Service Slide 20
Product Labelling Manufacturer s Trade Name/Mark: Full Postal Address: Web Address: (recommended but not mandatory) Importer s Label; Trade Name/Mark: Full Postal Address: Product Name/Type: Batch/Serial Number: Other Directives may require further data TÜV SÜD Product Service Slide 21
Language Manufacturer s Trade Name/Mark: Full Postal Address: Web Address: (recommended but not mandatory) Importer s Label; Trade Name/Mark: Full Postal Address: Product Name/Type: Batch/Serial Number: Other Directives may require further data TÜV SÜD Product Service Slide 22
Manufacturers Product label manufacturer s trade name/mark, postal address on product (or if not possible, on packaging/ documentation) Provide instructions for use On demand provide Market Surveillance Authorities with technical documentation, traceability of product and action on non-conforming products Shall not place non-conforming products on market or withdraw, recall if already on market inform the Market Surveillance Authorities if a risk with details of noncompliance where ever the product is available Monitor changes to state of the art (i.e. harmonised standards) 23
Authorised Representatives Must hold a formal written mandate that authorises them to perform specific tasks Tasks cannot include responsibility for design, manufacturing or preparation of technical documentation Tasks can include affixing CE marking and drawing up and signing Declaration of Conformity As a minimum must hold a copy of the Declaration of Conformity and Technical Documentation for a specified period (10 years) On demand provide Market Surveillance Authorities with copies of technical documentation and action on non-conforming products 24
Importers Product label Importer s name/mark and postal address in addition to Manufacturer s on product (or if not possible, on packaging/documentation) Must verify that products are correctly marked and that instructions are in in appropriate language and technical documentation is in place Must hold a copy of the Declaration of Conformity and retain for 10 years after placing on the market On demand provide Market Surveillance Authorities with copies of technical documentation, traceability of product and action on nonconforming products Shall not place non-conforming products on market or withdraw, recall if already on market inform the manufacturer and Market Surveillance Authorities if a risk 25
Distributors Must verify that products are correctly marked and that instructions are in in appropriate language and Declaration of Conformity and technical documentation are in place On demand provide Market Surveillance Authorities with copies of technical documentation, traceability of product and action on non-conforming products Shall not place non-conforming products on market or withdraw, recall if already on market inform the manufacturer and Market Surveillance Authorities if a risk 26
Rebranding - Rebadging Importers & Distributors can be considered manufacturers if they place apparatus on the market under their own name or trade mark, or modify apparatus already on the market TÜV SÜD Product Service Slide 27
Declaration of Conformity A single Declaration of Conformity for all directives Recital(34) allows a dossier of individual DoCs Must follow prescribed model structure Annex IV Adds; identification may include a colour image, Name, number of Notified Body where used Translated into the language required by the Member State where placed on the market The Declaration of Conformity to be continuously updated not defined but e.g. Due to changes in the product design Due to changes in the harmonised standards (state of the art) Due to change of manufacturer s details Top Tip: If product likely to be in continuous production beyond April 2016, to avoid reissuing DoC list both current and new EMC Directives 28
Conformity Assessment Procedures Annex II Module A Internal Production Control No significant change compared to 2004/108/EC Directive Self declaration by the manufacturer Annex III Part A Module B EU-type examination (by Notified Body) Annex III Part B Module C Conformity to type based on internal production control TÜV SÜD Product Service Slide 29
Module A Internal Production Control Article 14 Conformity assessment procedures for apparatus Annex II Module A Internal Production Control EMC assessment & technical documentation Manufacturing process & monitoring CE Marking Declaration of Conformity TÜV SÜD Product Service Slide 30
Module B - Notified Body Notified Body is a conformity assessment body (CAB) and UK BIS policy requires an accreditation certificate issued by national accreditation body (UKAS) Manufacturer selects a single Notified Body (within EU, or EFTA (Norway) or MRA (Australia, USA, Switzerland, New Zealand) listed in NANDO database No Notified Body number required for CE marking as no involvement in production control, but name & number required on Declaration of Conformity 31
Module B/C EU-Type Examination Article 14 Conformity assessment procedures for apparatus Annex III Module B EU-type examination (Notified Body) Manufacturer s application (technical documentation) Notified Body evaluates technical design / technical documentation, evaluation report & EU-type examination certificate Annex III Module C Internal Production Control (Manufacturer) Manufacturing process & monitoring CE Marking Declaration of Conformity TÜV SÜD Product Service Slide 32
EU-type examination certificate (Notified Body & Number) Manufacturer s name & address Identification of approved type Conclusions of the examination Essential requirements covered by the examination (emission and/or immunity) Conditions for validity Annexes if required TÜV SÜD Product Service Slide 33
Notified Body Ongoing Duties Notified Body monitors conformity; Changes to state of the art (i.e. harmonised standards) Manufacturer informs Notified Body of product modifications Notified Body asks manufacturer for corrective actions if product becomes nonconforming, otherwise suspend or withdraw certificate Notified Body informs Notifying Authority of; Certificates issued or withdrawn On request - Refusal, restriction, suspension or withdrawal of certificates Change to their notified scope or status Subcontracting Requests for information by Market Surveillance Authorities Notified Body informs other Notified Bodies for the same product of; Refusal, restriction, suspension or withdrawal of a certificate and on request, positive assessments and additions TÜV SÜD Product Service Slide 34
Summary What is Electromagnetic Compatibility (EMC)? EMC Directive Overview New EMC Directive 2014/30/EU TÜV SÜD Product Service Slide 35 35
TÜV SÜD EMC Services Notified Body Assessment Technical Documentation Compilation Technical Documentation Review Guidance in conducting an EMC Assessment Guidance in applying good EMC engineering practices in Fixed Installations Technical training, briefings and support for suppliers of rail infrastructure United Kingdom Accreditation Service (UKAS) accredited test laboratory for testing both at permanent premises and in-situ Radio Frequency (RF) and Low Frequency (LF) electromagnetic field surveys Power Quality measurements TÜV SÜD Product Service Slide 36 36
Additional Training Courses and Webinars Training Courses EMC Design - 3 days EMC Compliance of Military & Avionics Equipment - 1 day RF & Microwave Radiation Safety Course - 2 days Keep up-to-date http://www.tuv-sud.co.uk/uk-en/activity/training http://www.tuv-sud.co.uk/uk-en/activity/webinars TÜV SÜD Product Service Slide 37 37
Questions? Pete Dorey Tel: 01489 558211 Email: peter.dorey@tuv-sud.co.uk www.tuv-sud.co.uk TÜV SÜD Product Service Slide 38 38