TD Cover Letter

MDR Reference: N/A (NB administrative requirement)
BPG Rev.4 Reference: General Considerations (pp. 5-10)
Document Code: AII-COVER
Responsible Party: CRO / Manufacturer
Service Mode: Assist

Requirements Checklist

Cover Letter Content

• [ ] Application type (initial MDR, transfer, renewal, significant change)
• [ ] Device identification (trade name, Basic UDI-DI, product codes)
• [ ] Device classification and applicable classification rule(s)
• [ ] Scope of TD submission (device family, variants, accessories covered)
• [ ] Index/Table of Contents with hyperlinks to TD sections
• [ ] NB submission preferences acknowledged (format, language, structure)
• [ ] For MDD-to-MDR transition: previous NB assessment reference numbers
• [ ] Summary of any pre-submission communication with NB
• [ ] Language of submission documented
• [ ] Contact information for manufacturer's regulatory team

Submission Format (per BPG Rev.4 General Considerations)

• [ ] PDF format preferred; MS Office acceptable
• [ ] No scanned documents
• [ ] File path + name < 160 characters (Windows compatibility)
• [ ] No individual PDF > 100 MB
• [ ] PDF files bookmarked; documents >= 10 pages have internal ToC
• [ ] Reference IMDRF/RPS WG (PD1)/N27R2 for submission structure
• [ ] Consider IMDRF/RPS WG/N9 FINAL:2024 (Edition 4) nIVD ToC principles

Leveraging Previous Assessments

• [ ] For devices previously assessed under MDD/MDR by same NB:
  • [ ] Previous review ID / project number referenced
  • [ ] Clear indication of changed vs unchanged evidence/data
  • [ ] Extent of changes compared to previous assessment documented
  • [ ] GSPR checklist includes references to previously assessed evidence

Key Regulatory References

• MDR (EU) 2017/745, Article 52(12) (language requirements)
• MDCG 2019-6: Structured dialogue guidance
• IMDRF/RPS WG (PD1)/N27R2: Submission format guidance
• IMDRF/RPS WG/N9 FINAL:2024: nIVD ToC
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), General Considerations

Dependency

Cover Letter is the final deliverable in the TD package, prepared when all TD sections are complete and ready for NB submission.