Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.

Slides:



Advertisements
Similar presentations
Supplier’s Declaration of Conformity (SDoC)
Advertisements

Supplier’s Declaration of Conformity (SDoC)
European Commission Jacques McMillan Enterprise Directorate-General Legal aspects linked to internal market EUROPEAN CONFERENCE ON MARKET SURVEILLANCE.
Washington Laboratories (301) web: Lindbergh Dr. Gaithersburg, MD EMC Directive 2004/108/EC Steve Ferguson.
Standardisation, regulation, worldwide strategies 1 Modules of conformity assessment.
CE Regulation Service PROLAB Tech Rev 1 Machinery Directive Flow Chart A brief guide.
Workshop New Approach – Sofia, Bulgaria – 19/20 April Workshop on New Approach Directives for the Engineering Industry Focus on Directives Regulating.
Croatian Government’s Priorities in the Regulatory Area UNECE-SIDA “South East Europe Regulatory Project” Ljubljana, 8 June 2004.
S4: Market Surveillance Physikalisch-Technische Bundesanstalt Session 4: Market surveillance Peter Ulbig, Harry Stolz Belgrade, 31 October.
Serbia and Montenegro Council of Ministers Ministry of Internal Economic Affairs REGULATORY RULES TODAY AND TOMORROW Analytical overview: Mr Alija Haskic,
Harmonizing Technical Standards for CE marking and the European Union James W. Kolka Ph.D., J.D. President Kolka & Associates LLP Back to Outreach page.
Source: ec.europa.eu/CEmarking CE marking makes Europe’s market yours!
CE marking of technical products – bridge to the European market
Low Voltage Directive New Approach. Directive Overview Guidelines on application and Recommendations Safety objectives Documentation LVD standardisation.
The New EMC Directive 2004/108/EC and the DTI transposition Brian Jones and Peter Howick.
 The EMC Directive ◦ History ◦ Objectives ◦ Scope ◦ Essential requirements ◦ Harmonised standards ◦ Conformity assessment procedures ◦ Role of Member.
China Compulsory Product Certification System- CCC Mark.
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Anna Solé Mena Policy Officer - European Commission DG Enterprise and Industry.
8/21/20151 Neoteric Enterprises Inc. European Certification The CE Mark.
Phare SL Implementation of Technical Regulations on Company Level Breakout session EMC DIRECTIVE Expert: Heinz Wanda Chamber of Commerce and Industry,
U D T Workshop on the Pressure Equipment Directive, Warsaw June 2004 INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC SYSTEM OF ENSURING.
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Implementation of New Approach Directives in Bulgaria - Challenges and Opportunities Violina Panayotova - Director International Cooperation and European.
1 Security-related internal market measures on explosives FEEM AGM, Brussels, 5 June 2013 Julian Foley Desk Officer – Civil explosives and pyrotechnic.
Phare SL Implementation of Technical Regulations on Company Level Top Management Seminar Expert: Willem Wolf Chamber of Commerce and Industry,
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.
The EU Training Programme for Turkish Chamber Executives Electrical equipment Eurochambres Chamber House 19 A/D Avenue des Arts B-1000 Brussels Belgium.
June SURVEY OF EUROPEAN DIRECTIVES European directives are based on the new approach in order to provide free movement of goods in the single market.
S L O V A K I A. Since the 5 th meeting of CEFTA: Important changes have taken place in the Slovak Republic in the following areas: a/ further EC directives.
1 MARKET SURVEILLANCE IN THE EUROPEAN UNION A coordinate approach for metrology Lucia Palmegiani Policy Officer, DG ENTR I.5 WELMEC, WG 5, Malta, 23 October.
1 REPUBLIC OF TURKEY PRIME MINISTRY UNDERSECRETARIAT OF FOREIGN TRADE General Directorate of Standardization for Foreign Trade Presented by Selin ÖZŞAHİN.
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission 1 ATEX Directive 94/9/EC UNECE WP.6 Break-out session on equipment for explosive atmospheres.
The New Approach and GPSD. Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards [OJ C136 of June 1985] New Approach.
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Croatian Government’s Priorities in the Regulatory Area UNECE Round Table on Regulatory Cooperation in South East Europe Geneva, 22 November 2004.
1 MARKET SURVEILLANCE IN SWEDEN UN-ECE MARS GROUP, Bratislava October 2010 Amina Makboul
Directorate General for Enterprise and Industry European Commission The New Legislative Framework - Market Surveillance UNECE “MARS” Group meeting Bratislava,
Harmonizing Technical Standards for CE marking and the European Union Aims Management Consultants CE Marking Delhi Ph: /
The New EU Legislative Framework for Harmonisation Legislation for products Richard Lawson Deputy Director, Technical Regulations Sustainable Development.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.
European Commission REGULATORY MODEL OF THE EUROPEAN UNION Norbert ANSELMANN Head of Unit, ENTR G2, Standardisation Directorate.
Approximation of legislation to the internal market acquis An EU funded project managed by European Agency for Reconstruction Skopje, CE-
Mike Fahey HM Inspector of Health and Safety HSE, Cardiff.
The New Legislative Framework
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Electric safety requirements in European Community vehicle type-approval legislation GRSP ELSA sub-group – 6 th meeting Brussels, Belgium, April.
The actors in the product supply chain and their obligations Giuseppina Bitondo European Commission, DG GROW.
TAIEX GPSD Free Movement and Safety Vitomir Fister Beograd,
CLAUDIA PANAIT TAIEX Expert – European Commission Legal Adviser Ministry of Health, ROMANIA.
Conformity assessment in EU - 12 may Pascale MIENVILLE 1 Product Conformity Assessment Requirements for Access to the European Market CASCO/DEVCO.
M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 27 – Environment Bilateral screening:
THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS Responsibility in the handling of medical devices.
M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 1 –Free movement of goods Bilateral.
Date: in 12 pts MARKET SURVEILLANCE IN THE EU ROLE IN THE NLF - EU ACTIONS and DEVELOPMENTS Rita L'Abbate European Commission DG ENTERPRISE AND INDUSTRY.
M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 1 –Free movement of goods Bilateral.
WORK EQUIPMENT PEMBROKESHIRE ESTATES ENGAGEMENT PROJECT 30 SEPTEMBER 2015 Mike Fahey HM Inspector of Health and Safety HSE, Cardiff.
EET 422 EMC & COMPLIANCE ENGINEERING
Catherine Toozer HM Inspector of Health and Safety HSE, Carmarthen
REGULATORY RULES TODAY AND TOMORROW
EMC & COMPLIANCE ENGINEERING
EET 422 EMC & COMPLIANCE ENGINEERING
NMO Environmental Enforcement
Standards Comparison: USA and Europe
Mattias Skafar Head of Quality Division
ტექნიკური ბარიერები საერთაშორისო ვაჭრობაში
2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical.
INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC
General principles of the New Approach legislation
Presentation transcript:

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 2 CE MARKING LOGO CE Conformité Européenne European Conformity

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 3 CE MARKING LOGO

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 4 DATE ?

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 5 Machinery Directive (98/37/EC) year of construction under the CE marking Low Voltage Directive (73/23/EEC) EU Declaration of Conformity last two digits of the year CE affixed EMC (89/336/EEC) ?

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 6 WHERE TO PUT CE MARKING ? on the product or on the packaging or in manuals or other supporting literature

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 7 CE MARKING EUROPEAN CONTEXT part of European “New Approach” to harmonised technical regulations international standards used as a method of compliance with EU regulations 1980’s

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 8

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 9 CE MARKING WHAT IS IT ? a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 10 MORE THAN ONE DIRECTIVE APPLIES ONLY 1 CE MARK implies product complies with ALL applicable directives EU Declaration of Conformity per Directive

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 11 CE WHAT IS IT ? PRODUCT FREE CIRCULATION IN MEMBER STATES internal market for products aids competition

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 12 CE BENEFITS pre CE multiple conflicting national compliance systems post CE safer products enhanced products enhanced manufacturing processes

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 13 WHAT TO PUT CE ON ? 4 PRODUCT CATEGORIES components apparatus systems installations

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 14 COMPONENTS passive components: resistors capacitors semiconductors integrated circuits certain types of motor power supply units CD ROM electrical / electronic unit without a final function but which is intended for incorporation in an apparatus

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 15 APPARATUS domestic appliances medical equipment tools circuit-breakers certain motor types single finished product with (a) direct function(s) product intended for final use

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 16 SYSTEM computer system CPU+ keyboard+ printer+ monitor combination of apparatus and /or components constituting a single functional unit intended to be installed and operated to perform a specific task

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 17 INSTALLATION combination apparatus components systems assembled and/or erected in a given area industrial plants electricity substations telecontrol systems for large areas

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 18 INSTALLATIONS have to comply with the EMCD but NO assessment – NO CE marking Member State defines who is responsible for Compliance of the fixed installation applicable essential requirements protection requirements documented “Good Engineering Practice”

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 19 equipment apparatus component system networks large machines fixed installation

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 20 WHEN CE CAN BE PUT ON ? WHEN CONFORMITY IS ESTABLISHED based on the manufacturer’s chosen assessment procedure

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 21 GENERAL PROCESS TO CE MARKING determine the EU Directive applicable to the product determine the CE conformity test procedure applicable determine EU Harmonized Standards applicable to the product ensure the product is in compliance all EU Directives, standards and other requirements appropriate technical documentation, test reports and data sets prepare the official Declaration of Conformity for CE marking place CE marking on the product or packaging or documentation as applicable

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 22 WHO PUTS CE MARKING ON ? PRODUCT MANUFACTURER or AUTHORISED REPRESENTATIVE

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 23 CE LEGAL ASPECTS under EU law the company that places a product on the market or into service is responsible for CE marking manufacturer distributor agent in most cases the physical manufacturer is ultimately responsible

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 24 CE LEGAL ASPECTS NON-compliant products may be pulled of service permanently banned from of service permanently banned from European markets manufacturers and suppliers may incur criminal penalties and/or civil penalties

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 25

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 26 FINISHED PRODUCTS may contain bought-in sub-assemblies computer boards computers power supplies PLCs motor drives FINISHED SYSTEMS & INSTALLATIONS usually constructed from finished products s computers telecommunications equipment instrumentation and control equipment machinery

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 27

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 28 CE + CE = CE ?

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 29 +

Prof R T KennedyEMC & COMPLIANCE ENGINEERING 30 CE Conformité Européenne European Conformity