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Clinical Evaluation Report (CER)

Regulatory basis

MDR Annex XIV Part A, Section 4. The CER is the written output of the clinical evaluation process. It must be reviewed and updated throughout the device lifecycle and is a mandatory technical documentation element.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

What is the CER?​

The Clinical Evaluation Report (CER) is the structured document that records the entirety of the clinical evaluation process and conclusions. It is not simply a summary — it must document the methodology, data appraised, analysis, and conclusions with sufficient depth that a notified body can independently assess its scientific rigor.

A CER that merely summarises favourable literature without critical appraisal, addressing gaps, or linking to the risk management file is not compliant with MDR requirements.

CER structure — MDCG 2020-6 template​

The MDCG has published a template (MDCG 2020-6 rev.2) that represents best practice. Key sections:

Section 1 — Scope of the clinical evaluation​

  • Device identification (name, basic UDI-DI, model variants in scope)
  • Intended purpose (verbatim from technical documentation)
  • Intended users and use environment
  • Claimed performance characteristics
  • Applicable GSPR requiring clinical evidence

Section 2 — Clinical background and context​

  • Clinical background of the condition/disease being addressed
  • Current standard of care and available treatment/diagnostic options
  • Relevant clinical guidelines
  • Existing clinical evidence for the device type and therapeutic area

Section 3 — Device description relevant to clinical evaluation​

  • Description of the device and how it achieves its intended purpose
  • Previous generations and current marketed status
  • Any available equivalent devices (and justification of equivalence, if relied upon)

Section 4 — Clinical data — literature search​

  • Search protocol: databases searched (PubMed, EMBASE, Cochrane, etc.), date ranges, MeSH/keyword terms, inclusion and exclusion criteria
  • Search results: number of articles identified, screened, included, and excluded; PRISMA flow diagram recommended
  • Appraisal of included literature: for each included study, assess study design, sample size, follow-up duration, endpoints, risk of bias, and relevance to the device under evaluation
  • Synthesis: summary of what the literature collectively demonstrates

Section 5 — Clinical data — clinical investigations​

If clinical investigations have been conducted on the device or the equivalent device, document:

  • Study design, objectives, and endpoints
  • Results and statistical analysis
  • Adverse events and serious adverse events
  • Conclusions and limitations

Section 6 — Analysis of clinical data​

Systematic analysis of all clinical data against each clinical claim and GSPR requiring clinical evidence:

  • Is there sufficient data to demonstrate each claimed performance characteristic?
  • What is the clinical benefit in the intended patient population?
  • What are the clinical risks and their frequency/severity?
  • Is the benefit-risk positive and acceptable?

Section 7 — Clinical evaluation conclusions​

The CER must explicitly conclude:

  • Whether the device achieves its intended purpose
  • Whether the benefit-risk balance is positive
  • Whether there are residual uncertainties and how they are addressed
  • Whether the clinical evidence is sufficient for CE marking, or whether further data is needed

Section 8 — Post-market clinical follow-up (PMCF) plan reference​

Reference to the PMCF plan and justification of its adequacy — or justification if no PMCF is planned (rare and requires strong rationale).

Section 9 — Date and version control​

CER version number, date, and author qualifications.

Qualifications of the clinical evaluator​

MDR Annex XIV §1 requires that the clinical evaluation is conducted by persons with:

  • Relevant clinical expertise in the medical field relevant to the device
  • Adequate knowledge of clinical investigation methodology and biostatistics
  • Sufficient understanding of the device and its regulatory requirements

This does not require that the evaluator be a medical doctor — but for Class III devices and complex clinical areas, physician involvement is strongly expected by notified bodies.

The clinical evaluator's CV and qualifications must be included in or appended to the technical documentation.

Common CER deficiencies identified by notified bodies​

DeficiencyExplanation
Superficial literature appraisalStudies listed without critical assessment of quality or relevance
Equivalence not justifiedClaims of equivalence to another device without meeting all three MDR criteria
No literature search protocolSearch methodology not documented — cannot be reproduced or verified
CER not device-specificGeneric CER template not adapted to the specific device
Benefit-risk conclusion unsupportedConclusion not linked to the clinical data in the CER
PMCF plan absent or inadequateResidual uncertainties identified without adequate PMCF plan to address them
CER not updated post-marketStale CER not reflecting PMS/PMCF data accumulated since CE marking
Insufficient clinical expertise of evaluatorCV not included; evaluator lacks relevant clinical background

CER update frequency​

ClassMinimum update frequency
Class IWhen significant new data available or device changes
Class IIaWhen significant new data available; consider annual review
Class IIbAt least annually
Class IIIAt least annually

In practice, the PMCF evaluation report triggers CER updates for Class IIb and III devices as post-market data is collected.

Official references​

ReferenceDescription
MDR Annex XIV Part AClinical evaluation process and CER requirements
MDCG 2020-5Clinical evaluation guidance
MDCG 2020-6 rev.2CER template and guidance
MDCG 2019-6NB assessment of clinical evaluation documentation
EN ISO 14155:2020GCP for medical device investigations