Clinical Evaluation Report (CER) & Data Collection Report (DCR)

MDR Reference: Annex II, Section 6.3.3; Annex XIV Part A Section 4; Article 61(12)
BPG Rev.4 Reference: Section 6.3.3 (pp. 71-81)
Document Code: AII-S6-CER (CER), AII-S6-DCR (DCR)
Responsible Party: CRO
Service Mode: Write only

Data Collection Report (DCR)

Requirements Checklist

[ ] Literature search execution per CEP-defined strategy
[ ] SOTA literature search (benchmark/similar devices, alternative treatments)
[ ] Device-specific literature search (favourable/unfavourable data)
[ ] Pre-clinical evidence literature search (if applicable)
[ ] Database search results with hit counts per database
[ ] Deduplication records
[ ] Title/abstract screening results with inclusion/exclusion rationale
[ ] Full-text screening results
[ ] Quality appraisal of included articles (per MDCG 2020-6 criteria)
[ ] Full-text copies of key articles included in analysis
[ ] MAUDE/vigilance database search results
[ ] FSCA and Field Safety Notice review

Clinical Evaluation Report (CER)

Required Content (per BPG Rev.4 and MEDDEV 2.7/1 Rev.4)

[ ] Clear and comprehensive device description (all models/variants, clinical purpose, use in clinical pathway)
[ ] Specification of clinical evaluation update frequency with rationale
[ ] CVs and Declaration of Interests of all evaluators (including device end-user/medical professional)
[ ] Literature search protocol, report, database list
[ ] Full-text copies of key articles analysed

Clinical Evidence Analysis

[ ] Intended purpose and claims (consistent with AII-S1, IFU)
[ ] State of the Art (SOTA) analysis
[ ] Equivalence assessment results (if applicable, per Annex XIV Part A(3) and MDCG 2020-5)
[ ] For Class III/implantable equivalence: contract for ongoing TD access or sufficient access evidence per MDCG 2023-7
[ ] Clinical data analysis (literature + clinical experience + clinical investigations)
[ ] Clinical benefit assessment (EACH claimed benefit substantiated)
[ ] Risk assessment and residual risk acceptability (aligned with RMR)
[ ] Benefit-risk determination
[ ] Conclusions on clinical evidence sufficiency
[ ] PMCF needs identification

Clinical Investigation Documentation (if applicable)

[ ] Clinical investigation plan(s) and amendments (per MDCG 2024-3)
[ ] Completed investigation report signed by principal investigator(s)
[ ] Ethics committee approval evidence
[ ] All regulatory approvals (all countries, including outside EU)
[ ] Investigator's brochure (per MDCG 2024-5)
[ ] Informed consent template
[ ] Protocol deviations and justification/acceptance
[ ] For investigations outside EU: transferability analysis to European population
[ ] Statistical Analysis Plans (SAPs)
[ ] Public registration (EUDAMED or other registry)

Update Frequency

[ ] Update frequency defined per MEDDEV 2.7/1 Rev.4 guidance:
- Annual update for high-risk devices (Class III, implantable)
- 2-5 year cycle for lower-risk devices (with justification)
- Triggered by safety signals, new SOTA developments, device changes, PMCF findings
[ ] Clear criteria for triggered (unscheduled) updates
[ ] Update records maintained throughout lifecycle

Specific Requirements by Device Class

Document	Class IIa/IIb Non-Implant	Article 61(10)	Class IIa/IIb Implant	Class III Non-Implant	Class III Implant
CEP/CDP	Required	Required	Required	Required	Required
CER	Required	Required	Required	Required	Required
SSCP	Not required	Not required	Required	Required	Required
PMCF Plan	Required	Required	Required	Required	Required
PMCF Report	If available	If available	If available	If available	If available

Key Regulatory References

MDR (EU) 2017/745, Article 61 (Clinical evaluation)
MDR (EU) 2017/745, Article 62(11) (CER updates)
MDR (EU) 2017/745, Annex XIV, Part A
MEDDEV 2.7/1 Rev.4: Clinical evaluation (including Appendix 3 for CER ToC)
MDCG 2020-5: Equivalence
MDCG 2020-6: Sufficient clinical evidence
MDCG 2020-13: CEAR template
MDCG 2023-7: Article 61(4-6)
MDCG 2024-3: Clinical investigation guidance
MDCG 2024-5: Investigator's brochure guidance
MDCG 2024-10: Orphan devices
MDCG 2025-09: Breakthrough devices
Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 6.3.3

Common Pitfalls (from BPG Rev.4)

CER update frequency not defined or rationale incomplete
Article 61(10) misused: not applicable for Class III or implantable; not applicable when clinical data exists for similar devices
Intended purpose vague or inconsistent across documents
Clinical benefits not clearly differentiated (direct vs indirect)
Acceptance criteria (performance/safety thresholds) not defined based on SOTA
Literature search not comprehensive (missing SOTA, or device-specific search)
For non-EU investigations: no transferability analysis

Dependency

DCR depends on CEP (search strategy defined in CEP)
CER depends on DCR (evidence data) and CEP (evaluation strategy)
CER conclusions feed into RMR (benefit-risk), PMS Plan (indicators), PMCF Plan (objectives)
DCR and CER are Phase 3 deliverables

Clinical Evaluation Report (CER) & Data Collection Report (DCR) ​

Data Collection Report (DCR) ​

Requirements Checklist ​

Clinical Evaluation Report (CER) ​

Required Content (per BPG Rev.4 and MEDDEV 2.7/1 Rev.4) ​

Clinical Evidence Analysis ​

Clinical Investigation Documentation (if applicable) ​

Update Frequency ​

Specific Requirements by Device Class ​

Key Regulatory References ​

Common Pitfalls (from BPG Rev.4) ​

Dependency ​