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.