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NIST SP 951
A Guide to EU Standards and Conformity Assessment

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


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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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