Clinical Evaluation Plan (CEP)

MDR Reference: Annex II, Section 6.3; Annex XIV, Part A
BPG Rev.4 Reference: Section 6.3.1-6.3.2 (pp. 64-70)
Document Code: AII-S6-CEP
Responsible Party: CRO
Service Mode: Write only

Requirements Checklist (per Annex XIV Part A)

Identification of GSPRs Requiring Clinical Data (1a, first indent)

• [ ] All GSPRs requiring clinical data identified (at minimum GSPR 1 and 8)
• [ ] Alignment with GSPRs identified in other TD sections (GSPR checklist, CER)
• [ ] GSPR 5, 6, 15.1 considered where relevant
• [ ] For Article 61(10) devices: justification that clinical data not appropriate

Intended Purpose & Indications (1a, second/third indent)

• [ ] Clear, unambiguous intended purpose per MDR Article 2(12)
• [ ] Differentiation between indications and intended purpose (per MDCG 2020-6)
• [ ] Consistency across all TD documents (IFU, DoC, CER, GSPR, SSCP)

Clinical Benefits (1a, fourth/sixth indent)

• [ ] Direct and/or indirect clinical benefits clearly described
• [ ] Role of device in diagnosis/monitoring/treatment defined
• [ ] For indirect benefits: device's role in procedure/therapy delivery explained
• [ ] Clinical benefit claims substantiated by appropriate data sources

Benefit-Risk Parameters (1a, fifth indent)

• [ ] Indicative list of parameters for benefit-risk acceptability
• [ ] Performance and safety outcomes defined
• [ ] Methods for each outcome (objective tests, validated PROMs, etc.)
• [ ] Acceptance criteria based on State of the Art
• [ ] Comparison approach with currently available alternatives

Methods for Safety Examination (1a, fifth indent)

• [ ] Methods for collecting clinical risk/side-effect/residual risk data
• [ ] Qualitative and quantitative analysis methods specified
• [ ] Data sources identified (literature, clinical trial, PMS, PMCF, risk management)

Clinical Development Plan (CDP) (1a, final indent)

• [ ] For new devices: progression from exploratory to confirmatory investigations
• [ ] For legacy devices: strategy for obtaining clinical evidence per MDR Article 61
• [ ] PMCF activities referenced/planned
• [ ] For orphan devices: MDCG 2024-10 Section 7.1 considerations
• [ ] For BtX devices: MDCG 2025-09 Section 7.1 considerations

Literature Search Strategy

• [ ] Search protocol defining databases, search terms, date range
• [ ] Inclusion and exclusion criteria
• [ ] Screening and appraisal methodology
• [ ] State of the Art (SOTA) literature search objectives
• [ ] Device-specific and equivalent device literature search objectives

Equivalence Assessment (if applicable)

• [ ] Equivalence criteria per Annex XIV Part A(3) and MDCG 2020-5
• [ ] Technical, biological, and clinical characteristics comparison
• [ ] For Class III/implantable: contract for ongoing TD access (Article 61(5)) or sufficient access evidence per MDCG 2023-7

Clinical Investigation (if applicable)

• [ ] For Class III/implantable without investigation: rationale per Article 61(4-6) and MDCG 2023-7
• [ ] For new devices: justification if pre-market investigation not required
• [ ] Investigation plan aligned with CDP

Key Regulatory References

• MDR (EU) 2017/745, Article 61 (Clinical evaluation)
• MDR (EU) 2017/745, Annex XIV, Part A (Clinical evaluation requirements)
• MDCG 2020-5: Equivalence
• MDCG 2020-6: Sufficient clinical evidence / Legacy devices
• MDCG 2023-7: Article 61(4-6) justification for Class III/implantable
• MDCG 2024-10: Orphan devices
• MDCG 2025-09: Breakthrough devices
• MEDDEV 2.7/1 Rev.4: Clinical evaluation guidance
• MDCG 2020-13: CEAR template
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 6.3.1-6.3.2

Dependency

CEP is a Phase 2 deliverable. Depends on Device Description (AII-S1) being finalized. The CEP drives all subsequent clinical evaluation activities (DCR, CER) and PMCF planning.