TD Cover Letter / Submission Generalities (IVDR)
BPG reference: Team-NB BPG-IVDR V2 introductory and submission expectations (approx. pp. 1–6 and overall structure)
Document code: Sec.00 / Cover
Checklist
- [ ] Cover letter identifies manufacturer, device name, Basic UDI-DI, risk class, conformity assessment route and NB application scope
- [ ] Document index covering Annex II/III sections with versions and locations
- [ ] Submission language stated; translation control described
- [ ] IVDD legacy (certificate/self-declaration) and key changes summarised where applicable
- [ ] Critical outsourced sites and certificates indexed
- [ ] Confidentiality / electronic submission format per NB instructions
- [ ] Application scope matches the DD variant list