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30 CE MARKING HANDBOOK
Self-Declaration
(internal control of
production by
manufacturer)
Voluntary Certification
(internal control with EU
notified or competent
body assessment)
Mandatory Certification
(examination by
EU-notified or
competent body)
Manufacturer Performs
Assessment^
EU Body Performs
Assessment^
EU Body Performs
Assessment^
Manufacturers
Technical File
Manufacturers
Technical File
with EU Body Report
Technical File (safety)
orTCF(EMC)
with EU Body Report
EU Body Issues
Certificate and
Approval Mark
(random product checks)
EU Body Issues
Certificate
[Approval mark available]
(random product checks)
;
Manufacturer Issues
Declaration of Conformity
and Affixes CE Marking
Manufacturer Issues
Declaration of Conformity
and Affixes CE Marking
T
Manufacturer Issues
Declaration of Conformity
to Approved Type
and Affixes CE Marking
Ship Product to Europe"^
^ Manufacturer's assessment of the directive on the basis of conformity with European harmonized
standards and/or the ERs.
2 EC body assessment based on European harmonized standards or other criteria, that is, when no harmonized or equivalent national standard exists or in the case of innovation, another specification
deemed acceptable by EC body.
3 EC body assessment and approval of technical file based on European harmonized standards and/or
other criteria (i.e.. Annex IV listed machinery (89/392/EEC) or for EMC where standards are only
applied in part).
4 A technical file, declaration of conformity and CE marking is required under all three procedures.
Figure 2 - 6
Conformity Assessment Procedures
Voluntary certification. Oftentimes manufacturers have products assessed by a
European body (notified or competent) for a "mark and certification" for
marketing purposes and as a defense of "due diligence" in the event of a
challenge. The "intervention of notified body" certification route provides
confirmation of accuracy of the testing and documentation (test reports, etc.).