Module 12 Presentations

29/01/2024

CE Mark Flow

Technical File should • Prove that your Device is compliant to the requirements • Confirm that you have within it the official language of EU Member state (But English is the preferred language) • Be always available and up-to-date

Classification

Conformity Assessment

Technical File (Ax II & III)

Notified Body Audit

CE Certificate

Declaration of Conformity

©Copyright Easy Medical Device GmbH

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EC Declaration of Conformity

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©Copyright Easy Medical Device GmbH

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