Harmonizing Technical Standards for CE marking and the European UnionAims Management Consultants

CE Marking Delhi

Ph: 9212293916/9868301527

Email : info@isoconsultantsdelhi.com

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European Commission White Paper-March, 1985 Key technical statement from the EU

commission Contained 300 pieces of legislation

(reduced to 286 )

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White Paper pledged to eliminate fiscal, technical and physical barriers Replace national standards with EU

standards Eliminate national regulations that

restrict trade Agree on EU wide certification and test

procedures

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EU created new approach directives Create a framework for compliance and

conformity assessment Identify essential safety requirements Create EN harmonized standards to

implement the directive Create both safety and quality

requirements

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New approach directives(cont.) Multiple EN harmonized standards have

been created to implement each directive

Example- Machinery Safety Directive contains approximately 1000 standards for implementation

EU Medical Devices Directives are being harmonized with the FDA

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New approach directives (cont.) CE marking is a legal requirement for all

products affected by new approach directives

The operative language is “placing on the market”

Unmarked or illegally marked products are subject to civil fines and criminal sanctions

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New approach directives (cont.) Compliance with directive requirements

means market entry throughout the EU Compliance is not a casual response-it

will require time, money and effort Other countries are adopting EU

approaches to product safety

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Products affected by EU new approach directives Toys, Construction Products,

Telecommunications Equipment, Machinery, Active Implantable Medical Devices, Medical Devices, In Vitro Diagnostic Medical Devices, Personal Protective Equipment, Hot Water Boilers Fired with Liquid and Gaseous Fuels, Appliances Burning Gaseous Fuels

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Products (cont.)

Simple Pressure Vessels, Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres, Recreational Craft, Lifts, Non-Automatic Weighing Instruments, Marine Equipment, Cableway Installations Designed to Carry Passengers, Pressure Equipment, Low Voltage, Electromagnetic Compatibility

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EU Approach to Product Safety Will affect substantial number of

products in world trade Directives and standards requirements

apply to all manufacturers (US&EU) who wish to do business in the European Union

Several countries are adopting the EU approach

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