all about EU and CE Marking requirements

Contents Introduction to Europe: A Single Market 1 Harmonization: A New Approach to Lawmaking 1 Table 1: New Approach Directives 2 Essential Health and Safety Requirements: An Example 3 Technical Harmonization: Conformity Assessment 4 Harmonization: The Global Approach 4 Conformity Assessment: The Module Decision 5 Modules 7 Table 2: Modules: Conformity Assessment Procedures in European Legislation 8 Table 2: Conformity Assessment Procedures in European Legislation (Continued) 9 Technical Harmonization: Standardization 10 The European Standards Bodies: CEN, CENELEC, and ETSI 10 The Role of Standards in New Approach Directives 10 Harmonized Standards and the Presumption of Conformity 11 The Role of Standards in the Marketplace 11 European National Standards 12 National Standards (Mutual Recognition) 12 Table 3: European Standards Bodies: CEN National Members 13 Table 4: European Standards Bodies: CENELEC National Members 14 Table 5: European Standards Bodies: ETSI 15 Standardization in the EU and the United States: A Comparison Similarities Differences The Relationships 15 15 15 16 ISO 9000 16 Introduction to the Basic Principles of Compliance 17 CE Marking 17 Determining Which Directives Apply to the Product 17 Who Affixes the CE Mark 18 Placing on the Market 19 Self-Certification 20 Notified Bodies 20 Competent Bodies 21 Competent Authorities 21 Mutual Recognition Agreements 22 EC Type-Examination 22 Manufacturer 22 The Importer 23 Private Labeler 23 Authorized Representative 23 Technical File 24 Content of the Technical File 24 Risk Assessment 25 User's Manual 26 Language 26 Declaration of Conformity 26 Sample Declaration of Conformity Language Signature of Declaration of Conformity 28 29 29 Declaration of Incorporation 30 Sample Declaration of Incorporation 31 Product Liability 32 National Marks 33 Surveillance Authorities 33 Return to the Table of Contents Previous Page Next Page Technology Services, Standards Services Division, Global Standards and Information Group Contact: maureen.breitenberg@nist.gov A Guide to EU Standards and Conformity Assessment, NIST SP 951 Date Created: 05/31/00 Last Modified: 05/31/00

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