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Clinical evaluation summary in the technical file

Regulatory basis

Clinical evaluation is required to demonstrate conformity with the Essential Requirements (particularly ERs 1, 2, 3, and 6) under Schedule 1 of the UK MDR 2002. Full clinical evaluation requirements are addressed in Clinical evaluation requirements.

The Clinical Evaluation Report (CER) in the technical file​

The Clinical Evaluation Report (CER) is the document that summarises the clinical evidence for the device and draws conclusions about its clinical safety, performance, and benefit-risk balance.

The CER is both:

  • A standalone document (typically the most substantial clinical document a manufacturer produces)
  • A core component of the technical file, directly referenced by the Essential Requirements checklist

The technical file must contain the current, complete CER — not a summary or extract. For Class III devices and AIMDs, the CER is part of the design dossier reviewed by the UKAB.

Relationship between the CER and other technical file elements​

The CER does not stand alone — it draws on and links to multiple other technical file elements:

Technical File
│
├── Device description (scope of CER)
│       │
├── Risk management file ←──────────────────→ CER (risk-benefit balance)
│       │                                       │
├── Pre-clinical test reports ────────────────→ CER (referenced as supporting evidence)
│       │                                       │
├── Clinical investigation reports ──────────→ CER (primary clinical data source)
│       │                                       │
├── Literature search and appraisal ─────────→ CER (state-of-the-art evidence)
│       │                                       │
└── PMCF reports (post-market) ──────────────→ CER update (ongoing clinical data)

What the CER must address​

The CER is expected to cover:

  1. Clinical background — the clinical condition being addressed, current standard of care, unmet need
  2. Device description — summary of the device and its intended purpose (consistent with the device description section)
  3. Clinical evaluation plan — the methodology used (literature search strategy, equivalent device rationale, clinical investigation data)
  4. Literature review — systematic search, appraisal, and synthesis of clinical data from the literature
  5. Equivalent device data (if used) — demonstration of equivalence (technical, biological, clinical) to a device for which clinical data exists; limitations of equivalence
  6. Clinical investigation data — results from any clinical investigations of the device itself
  7. Post-market clinical data — adverse event reports, complaint data, PMCF study results, registry data (for devices already on the market)
  8. Clinical performance assessment — does the device perform as claimed?
  9. Clinical safety assessment — what are the risks, what is their frequency, are they acceptable?
  10. Benefit-risk determination — integrating performance and safety to reach a net benefit-risk conclusion
  11. Conclusions — does the clinical evidence support a positive benefit-risk balance for the intended purpose?
  12. Date of CER and next scheduled update

CER currency and update frequency​

The CER must be current — it must reflect the most recent available clinical evidence. For higher-risk devices:

  • Class III and AIMD: CER should be reviewed and updated at least annually; PMCF data must be incorporated
  • Class IIb: CER update at minimum every 2 years; review annually
  • Class IIa: CER update when triggered by new clinical evidence, safety signals, or PMCF findings

For the GB market, MHRA expects the CER update frequency to be proportionate to the device's risk class and the rate at which new clinical data becomes available.

Post-market data in the technical file​

Post-market data must be incorporated into the technical file on an ongoing basis:

Data sourceHow incorporated
Post-market surveillance (PMS) dataPMS report → reviewed in CER update
PMCF study resultsPMCF report → CER update
Adverse event reports and MHRA communicationsSafety data → risk management update → CER
Published literature (new articles on the device or equivalents)Literature search update → CER
Registry dataData extraction → CER
Periodic Safety Update Reports (PSURs)Summary conclusions → CER

The technical file must show a live feedback loop between the device's post-market experience and its clinical evidence base.

Official references​

ReferenceDescription
UK MDR 2002, Schedule 1, ER 1–3Essential Requirements supported by clinical evaluation
MEDDEV 2.7/1 Rev.4Clinical evaluation guidance — widely applied in UK context
MHRA: Clinical evaluation guidanceMHRA's position on clinical evaluation requirements
EU MDR 2017/745, Annex XIVEU clinical evaluation requirements (comparative reference)