
Sample dossier
CE documentation (technical file)
Stays with the manufacturer and is presented to the market surveillance authority on request.
The internal file: risk assessment per EN ISO 12100, standards applied, EU Declaration of Conformity, technical documentation per Annex IV, test reports, functional safety, cybersecurity and an excerpt of the operating instructions. Eight modules in one document.
Eight modules
- ·Risk assessment (42 hazards)
- ·Standards applied (24 standards)
- ·Declaration of Conformity (1 declaration)
- ·Technical documentation (97 % complete)
- ·Test reports (74 of 78 test items)
- ·Functional safety (5 safety functions)
- ·Cybersecurity (8 of 9 sections fully documented)
- ·Operating instructions (13 chapters, excerpt)
