Technical 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 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)