
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 and cybersecurity. Seven modules in one document.
Seven modules
- ·Risk assessment (42 hazards)
- ·Standards applied (24 standards)
- ·Declaration of Conformity (1 declaration)
- ·Technical documentation (96 % complete)
- ·Test reports (64 of 68 test items)
- ·Functional safety (5 safety functions)
- ·Cybersecurity (8 of 9 sections fully documented)
