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Identify

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

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