Design & Manufacturing Information

MDR Reference: Annex II, Section 3
BPG Rev.4 Reference: Section 3 (pp. 22-25)
Document Code: AII-S3
Responsible Party: Manufacturer (Client)
Service Mode: Assist / Review

Requirements Checklist

3(a) Design Stages

• [ ] Information to understand the design stages applied to the device
• [ ] Design phase reviews with meeting minutes and reports
• [ ] Design history documentation (not generic SOPs, but device-specific records)

3(b) Manufacturing Processes

• [ ] Manufacturing flowcharts identifying all processes (validated/verified, in-process/final controls)
• [ ] Subcontracted process stages identified in flowchart
• [ ] Detailed manufacturing procedures and controls (including subcontracted)
• [ ] Critical process verification protocols/plans/reports
• [ ] Incoming material testing procedures and acceptance criteria
• [ ] Sample batch incoming inspection results for critical raw materials/sub-assemblies
• [ ] Continuous monitoring / in-process controls with specifications and acceptance criteria
• [ ] Final (release) product specification, testing, and acceptance criteria
• [ ] Sample batch final inspection results for finished devices
• [ ] Identification of party responsible for subcontracted process inspection
• [ ] Process validation reports (OQ and PQ) with:
  • [ ] Precise equipment identification
  • [ ] Validation report references (ID, revision, date)
  • [ ] Critical process parameters and validated tolerance intervals
  • [ ] Worst-case product size and sample size justification
  • [ ] Multi-site validation (same process/equipment at multiple sites)
• [ ] Master Validation Plan (MVP) for safety-critical processes
• [ ] Working environment description including classification and controls
• [ ] Description of adjuvants used (additives, processing aids per ISO 10993-1)
• [ ] For installable devices: installation/commissioning test information
• [ ] Non-English manufacturing documentation: translations or summary reports

3(c) Sites, Suppliers & Subcontractors

• [ ] Name and address of all critical subcontractors with service/material description
• [ ] ISO 13485 certificates for critical subcontractors (or justification if absent)
• [ ] Design site identification (including outsourced design units, research sites)
• [ ] Manufacturing site identification with process stages
• [ ] Quality assurance agreements with critical subcontractors
• [ ] Sterilisation company contract (if applicable)
• [ ] OOS event responsibilities in agreements
• [ ] Multi-site company: specific sites involved identified
• [ ] EUDAMED registration for other manufacturers (when applicable)

Key Regulatory References

• MDR (EU) 2017/745, Annex II, Section 3
• EN ISO 13485:2016: Medical devices -- Quality management systems
• EN ISO 14971:2019+A11:2021: Risk management (manufacturing risk aspects)
• ISO 10993-1: Biological evaluation -- adjuvants definition
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 3

Common Pitfalls (from BPG Rev.4)

• For legacy devices: no design stage information provided
• Manufacturing flowchart does not clearly show locations of manufacturing/inspection steps
• Only re-validation documentation without initial validation support
• Worst-case and sample sizes not justified based on risk analysis
• Multi-site processes validated at only one site without justification
• Subcontractor addresses incomplete or secondary sites missing
• Quality agreements missing device-specific specifications (BOM, regulatory aspects)

Dependency

This is a Phase 1 deliverable. Manufacturing information is foundational for understanding the device but is primarily a client responsibility. CRO involvement is typically limited to gap analysis and review.