GSPR Checklist

MDR Reference: Annex II, Section 4; Annex I
BPG Rev.4 Reference: Section 4 (pp. 26-27)
Document Code: AII-S4
Responsible Party: CRO
Service Mode: Assist

GSPR Compliance Matrix Structure (BPG Rev.4 Required Columns)

The GSPR checklist must include the following information for each clause/sub-clause of MDR Annex I:

Column	Description
Applicable / Not Applicable	Decision for each GSPR clause with rationale for non-applicability
Method Used	Method(s) used to demonstrate conformity
Applied Standards, CS, or Other	Harmonised standards, Common Specifications, or other solutions (edition/issue date)
Controlled Document Reference	Precise identity of evidence documents (Document ID, date, section, page, chapter, link)
Version Control	Per manufacturer QMS procedures

Requirements Checklist

General Requirements (Annex I, Chapter I, GSPR 1-9)

• [ ] GSPR 1: General safety and performance (benefit-risk acceptable, SOTA)
• [ ] GSPR 2: Risk minimisation hierarchy applied (inherent safety -> protective measures -> information)
• [ ] GSPR 3: Design and manufacture (intended purpose, foreseeable conditions, transport/storage)
• [ ] GSPR 4: Safety hierarchy for risk reduction
• [ ] GSPR 5: Eliminate/reduce use-related risks (usability engineering)
• [ ] GSPR 6: Device performance during intended lifetime
• [ ] GSPR 7: Transport and storage conditions
• [ ] GSPR 8: Benefit-risk determination documented
• [ ] GSPR 9: Annex XVI devices -- risk acceptability

Specific Safety Requirements (Annex I, Chapter II)

• [ ] GSPR 10: Chemical, physical and biological properties
  • [ ] 10.4: CMR/endocrine disrupting substances (> 0.1% w/w justification per GSPR 10.4.1-10.4.5)
• [ ] GSPR 11: Infection and microbial contamination
• [ ] GSPR 12: Devices incorporating substances (medicinal, non-viable biological)
• [ ] GSPR 13: Devices incorporating human/animal origin materials
• [ ] GSPR 14: Devices and their interaction with environment
  • [ ] 14.6: Usability of active devices
• [ ] GSPR 15: Devices with diagnostic/measuring function
• [ ] GSPR 16: Protection against radiation
• [ ] GSPR 17: Electronic programmable systems, software, connected devices
  • [ ] 17.3: Mobile platforms requirements
  • [ ] 17.4: Hardware requirements, IT network, cybersecurity per MDCG 2019-16
• [ ] GSPR 18: Active devices (energy delivery, substances)
• [ ] GSPR 19: Combination products (devices with medicinal products)
• [ ] GSPR 20: Mechanical and thermal risks
• [ ] GSPR 21: Risks to patients/users from supplied energy/substances
  • [ ] 21.3: Usability for active devices
• [ ] GSPR 22: Active implantable devices

Information & Labelling (Annex I, Chapter III)

• [ ] GSPR 23: Label, IFU, and information requirements
  • [ ] 23.1: Website IFU availability
  • [ ] 23.4: IFU content requirements (including 23.4(p) and 23.4(v))

Compliance Evidence (ALL must be addressed)

• [ ] For EACH applicable GSPR: precise reference to standard/test report/design data
• [ ] For non-applicable GSPRs: justification/rationale provided
• [ ] Harmonised standard references with full or partial compliance indicated
• [ ] Gap analysis where: (i) key standards not applied/partially applied; (ii) newer standard version used; (iii) outdated standards applied
• [ ] Where no standards applied: justification + qualification/validation of alternative method
• [ ] Additional directives considered where relevant (Machinery, EMC, RoHS, European Pharmacopoeia)

Key Regulatory References

• MDR (EU) 2017/745, Annex I (General Safety and Performance Requirements)
• MDR (EU) 2017/745, Annex II, Section 4
• MDCG 2021-5: Harmonised standards guidance
• MDCG 2020-3: GSPR references
• MDCG 2019-16: Cybersecurity guidance
• EN ISO 14971:2019+A11:2021: Risk management
• EN 62366-1:2015+A1:2020: Usability engineering
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 4

Common Pitfalls (from BPG Rev.4)

• Standard applied without justification (e.g. vascular graft standard for surgical mesh)
• No systematic evaluation of relevant literature, best practice guidelines, and standards
• "Not applicable" GSPRs lack justification/rationale
• Evidence references are generic -- not specific document ID, section, page

Dependency

The GSPR has two phases:

1. Phase 1 (Gap Analysis): Initial framework using standard-to-requirement mapping as an internal tool for identifying evidence gaps
2. Phase 4 (Final Version): Complete compliance declarations with all evidence references from all TD sections

Depends on: AII-S1 (Device Description), AII-S5 (RMR), AII-S6 (CER), and all verification/validation reports.