B2. CE Technical File 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)