Declaration of Conformity
The last step: the manufacturer needs to write a statement affirming that the device meets all the essential requirements set out in Directive 93/42/EEC and has undergone the appropriate conformity assessment procedures and is designed in accordance with the technical documentation.
The Declaration of Conformity (DoC) has to be available to authorities at the EU point of entry, which means: to the EU distributor. A copy must be kept for at least 10 years after the product is placed on the market.
WRITE DECLARATION OF CONFORMITY
It is a one-page document that includes:
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name of the manufacturer and authorized representative
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product or family product (and all its variants, catalog numbers
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directives involved
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class of device
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standards used
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where test results can be found, conformity assessment procedure
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notified body name and number
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certificate number
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regulatory affairs specialist of the company
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place and date of issue.
CEEASY offers you the perfect template.
If a notified body is involved in the conformity assessment, the four digit identification number of the Notified Body should be placed below or beside (in the right side) of the CE conformity mark.
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The vertical dimension may not be less than 5mm, and proportions must be respected.
Affix CE Marking
Download the image from the European Comission's website.
