Information Supplied by the Manufacturer

MDR Reference: Annex II, Section 2
BPG Rev.4 Reference: Section 2 (pp. 19-21)
Document Code: AII-S2
Responsible Party: Manufacturer (Client)
Service Mode: Assist / Review

Requirements Checklist

2.1 Declaration of Conformity (DoC)

• [ ] Draft EU DoC per MDR Annex IV (for initial MDR certification)
• [ ] Signed EU DoC (for already MDR-certified devices)
• [ ] Basic UDI-DI consistent with TD and labelling

2.2 Labelling

• [ ] Device/product labelling in all required EU Member State languages
• [ ] Sterile packaging labelling (if applicable)
• [ ] Single unit, sales, and transport packaging labelling
• [ ] Software-displayed labels
• [ ] Markings applied on device itself (method specified, e.g. laser marking)
• [ ] Legible versions of all packaging levels with all symbols
• [ ] Drawings showing packaging configuration and label placement
• [ ] Label specifications (layout, size)
• [ ] Verification against MDR Annex I GSPR 23
• [ ] UDI carrier per Article 27(4) and Article 123.3(f)
• [ ] Compliance with applicable harmonised standards (e.g. EN ISO 15223-1)
• [ ] For Annex XVI devices: CS-specific labelling requirements

2.3 Instructions for Use (IFU)

• [ ] IFU in all required Member State languages
• [ ] Alignment of intended purpose, indications, contraindications across IFU and all other documents
• [ ] All information required by MDR Annex I GSPR 23
• [ ] Standard-specific IFU requirements (EN 60601-1, EN ISO 17664, EN ISO 14630, etc.)
• [ ] Cybersecurity information per MDCG 2019-16
• [ ] Surgical technique, user manual, installation/service manuals (if applicable)
• [ ] For devices without IFU: information per GSPR 23.4(p) and 23.4(v)

2.4 Electronic IFU (e-IFU)

• [ ] Compliance with Regulation (EU) 2025/1234 amending 2021/2226
• [ ] e-IFU available on manufacturer's website in required languages
• [ ] Consistency between electronic and paper IFU
• [ ] Risk assessment for e-labelling per regulation requirements
• [ ] e-labelling information as provided on device/leaflet

2.5 Patient Handbook

• [ ] Patient handbook (if separate from IFU) in required languages
• [ ] Language adapted for patient comprehension level

2.6 Physicians'/Users' Handbook

• [ ] Separate physicians' handbook (if applicable) in required languages

2.7 Implant Card

• [ ] Implant card per Article 18 and MDCG 2019-8
• [ ] Device type per MDCG 2021-11
• [ ] Location of implant card within packaging specified
• [ ] Translation approach for non-symbol information

2.8 Promotional Materials

• [ ] All marketing materials reviewed against MDR Article 7
• [ ] CE mark + NB number only in materials mentioning MDR compliance
• [ ] Claims substantiated by pre-clinical and clinical evidence

2.9 Website Information

• [ ] URL where IFU and safety/performance information are published per GSPR 23.1
• [ ] Information kept up to date

Key Regulatory References

• MDR (EU) 2017/745, Annex II, Section 2
• MDR (EU) 2017/745, Annex I, GSPR 23 (Labelling and IFU requirements)
• MDR (EU) 2017/745, Annex IV (DoC)
• MDR (EU) 2017/745, Article 7 (Claims)
• MDR (EU) 2017/745, Article 18 (Implant card)
• Regulation (EU) 2025/1234 amending 2021/2226 (e-IFU)
• MDCG 2019-9: SSCP guidance (for labelling alignment)
• MDCG 2019-16: Cybersecurity
• EN ISO 15223-1: Symbols for medical device labelling
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 2

Common Pitfalls (from BPG Rev.4)

• Basic UDI-DIs assigned incorrectly, causing amendments during assessment
• UDI-DI inconsistent across application, DoC, TD, PSUR, and vigilance reports
• Intended use and indications used interchangeably (use MDCG 2020-6 definitions)
• IFU missing GSPR 23.4 requirements (compatible accessories, SSCP links)
• Lack of 1:1 alignment across all labelling documents
• Patient SSCP section is a copy of healthcare professional section (readability not considered)

Dependency

This is a Phase 1 deliverable. Must be finalized before clinical evaluation (CEP/CER) as labelling claims must be consistent with clinical evidence. IFU and labelling updates may be triggered by clinical evaluation findings in Phase 3.