Professional Documents
Culture Documents
applicable
Directives
Identify
applicable
standards
Yes
Can you
self-certify
the
product?
Identify suitable
Notied Body
and submit
product for testing
Assess product
against applicable
requirements
No
Does product
comply with
applicable
requirements?
Can
non-compliances
be corrected without
compromising
function?
No
Yes
No
Product
cannot be
CE marked
Yes
Compile the
Technical File
Correct
non-compliances
Can product be
justied as meeting
Essential
requirements
or Directives?
Yes
No
Issue Declaration
of Conformity
Document technical
justication for
non-compliances
Ax the
CE Mark