Documents checklist
1. Manufacturer’s business registration2. ISO 13 485 (or ISO 9001)
3. Certificate MDD 93/42/ЕЕС (or another applicable Directive for medical product)
4. Declaration of conformity
5. Medical product description
6. Technical file (that was used for CE certification, including test reports, clinical evaluation, risk management)
7. User manual (with all accessories and reference numbers description)
8. Label draft (product and packaging)
9. Product photos including accessories and product components
10. List of applicable standards