- Essential information for any manufacturer or distributor wishing to trade in the European Union
- Practical and easy to understand
Table of Contents
- 1. BACKGROUND TO THE NEW APPROACH DIRECTIVES: European Directives; Transition Period and Overlapping of Directives; Application; Mutual Recognition Agreements/European Conformity Assessment Protocols; Types of Directives and Standards; Concurrent Application of Directives; Aim of Standardisation; International Standardisation; Harmonised European Standards; Revision of Harmonised Directives; Management of the List of Standards; Recognition of European Standards. 2. STRUCTURE OF NEW APPROACH DIRECTIVES: Articles; Adoption of New Approach Directives; Transposition of New Approach Directives; Advisory Committee; Review and Reporting; Transitional Provisions; Repeal; Entry into Force. 3. STRUCTURE OF THE CE CONFORMITY MARKING DIRECTIVE (93/465/EEC): Main Part; General Guidelines; Conformity Assessment Modules - Short Description; Choice of Module; CE Marking; Industrial Product Type conformity; Competent Authority; Notified Bodies; Essential Standards for Notified Bodies; Relevant Standards of the EN45000 Series for Each Module; Notified Bodies Tasks Under Each Module; Requirements of the Various Directives affected by CE Marking; Content of the Directives; Conformance; Principle Directives; Other Directives; Medical Devices - in vitro diagnostics (COM (95) 130) 180; Other Directives Associated with the CE Marking Directive.
4. GAINING OF CONFORMITY: Self Declaration; Voluntary Certification; Mandatory Certification; The 5 Steps to Conformity; Quality Management System; Conformity Assessment Procedures; Conformity requirements of each Module; Conformance Requirements of New Approach Directives; Manufacturers; Manufactuer's Tasks Under Each Module; Basic Requirements of manufacturers of Industrial Products; Registration of manufacturers; EC Verification; Design and Construction Requirements; Index.
- No. of pages: 285
- Language: English
- Copyright: © Butterworth-Heinemann 2000
- Published: May 1, 2000
- Imprint: Butterworth-Heinemann
- eBook ISBN: 9780080500812
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