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Ce Mark – Medical Device Directive

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CE Mark – Medical Device Directive

Break 1

European Union

Introduction to European Directives.
Cyprus, Czech Republic Estonia, Latvia, Lithuania, Malta Slovakia Slovenia Turkey
January 2006 KM Loi & Associates 1 January 2006 KM Loi & Associates

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom
2

New Approach – 98/34/EC
In 1985, a Directive on New Approach to Technical Harmonization and Standards was established to promote free movement of goods within Europe. It agreed to gradually remove the product regulatory and safety requirements of each individual country and replace them with essential requirements to cover all of Europe based on prevention of new barriers to trade, mutual recognition and technical harmonization.
January 2006 KM Loi & Associates 3

EU – Single Market
EU Policy and Regulation EU Policy and Regulation
EU Directives
Essential Requirements

Manufacturer Manufacturer or or Representative Representative
Product and Services

January 2006

KM Loi & Associates

4

Directive 98/34/EC
A single market - December 31, 1992.
• • • • Harmonization is limited to Essential Requirements. Only products fulfilling ER can be placed on the market and put into services. Published Harmonized standards are presumed to conform to corresponding essential requirements. Harmonized standards and technical specifications are voluntary and manufacturers are free to choose any route to meet compliance with ER. Manufacturers may choose between different conformity assessment procedures.
KM Loi & Associates 5

Global Approach
Free Movement of Goods.
• New Approach Directives apply to products which are intended to be placed (or put into service) in the European Union. It is the responsibility of manufacturer to verify whether the product is

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