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Saturday, May 15, 2010

all about EU and CE Marking requirements

Contents
Introduction to Europe: A Single Market1
Harmonization: A New Approach to Lawmaking1
Table 1: New Approach Directives2
Essential Health and Safety Requirements: An Example3
Technical Harmonization: Conformity Assessment4
Harmonization: The Global Approach4
Conformity Assessment: The Module Decision5
Modules7
Table 2: Modules: Conformity Assessment Procedures in European Legislation8
Table 2: Conformity Assessment Procedures in European Legislation (Continued)9
Technical Harmonization: Standardization10
The European Standards Bodies: CEN, CENELEC, and ETSI10
The Role of Standards in New Approach Directives10
Harmonized Standards and the Presumption of Conformity11
The Role of Standards in the Marketplace11
European National Standards12
National Standards (Mutual Recognition)12
Table 3: European Standards Bodies: CEN National Members13
Table 4: European Standards Bodies: CENELEC National Members14
Table 5: European Standards Bodies: ETSI15
Standardization in the EU and the United States: A Comparison
Similarities
Differences

The Relationships
15

15
15

16
ISO 900016
Introduction to the Basic Principles of Compliance17
CE Marking17
Determining Which Directives Apply to the Product17
Who Affixes the CE Mark18
Placing on the Market19
Self-Certification20
Notified Bodies20
Competent Bodies21
Competent Authorities21
Mutual Recognition Agreements22
EC Type-Examination22
Manufacturer22
The Importer23
Private Labeler23
Authorized Representative23
Technical File24

Content of the Technical File

24
Risk Assessment25
User's Manual26
Language26
Declaration of Conformity26
Sample Declaration of Conformity
Language
Signature of Declaration of Conformity
28
29
29

Declaration of Incorporation30

Sample Declaration of Incorporation

31
Product Liability32
National Marks33
Surveillance Authorities33


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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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For questions concerning the Global Standards and Information Group, contact us:

Global Standards and Information Group
Standards Services Division, NIST
100 Bureau Drive, Stop 2100
Gaithersburg, MD 20899-2100





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