Technical CE file for medical devices

Technical file for medical devices

In this file you will find the following documents:

• Legal framework (basic document based on CE legislation in WORD)
• Risk analysis (basic document with the requirements from Medical Devices Regulation (EU) 2017/745 in XLS)
• Instructions for use (information document: what should be included in an instruction manual as a minimum? (WORD))
• Conformity assessment (information document: Flowchart; can you certify yourself or is the intervention of a Notified Body necessary? (WORD))
• CE label (information document: what should be on the CE marking? (WORD))
• (EU) Declaration of Conformity (Basic document of a model declaration in WORD)

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