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B2. CE Technical File Medical Devices

B2. CE Technical File Medical Devices

€ 49,95 exclusief BTW
€ 60,44 inclusief BTW

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Example technical file for Medical Devices

A zip file with a folder structure in it:
- Legal framework (basic document based on CE legislation in WORD)
- Risk analysis (basic document with the requirements of the Medical Devices Regulation (EU) 2017/745, in XLS)
- Instructions for use (information document: what should be mentioned in a user manual?)
- Conformity assessment (information document: Flowchart; self certification or is the intervention of a Notified Body necessary? (WORD))
- CE label (information document: what should be mentioned on the CE marking?)
- Declaration of Conformity (basic document of a model declaration in WORD)

After payment you will receive an e-mail containing a download link for the ordered document.