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

Deficiency	Explanation
Superficial literature appraisal	Studies listed without critical assessment of quality or relevance
Equivalence not justified	Claims of equivalence to another device without meeting all three MDR criteria
No literature search protocol	Search methodology not documented — cannot be reproduced or verified
CER not device-specific	Generic CER template not adapted to the specific device
Benefit-risk conclusion unsupported	Conclusion not linked to the clinical data in the CER
PMCF plan absent or inadequate	Residual uncertainties identified without adequate PMCF plan to address them
CER not updated post-market	Stale CER not reflecting PMS/PMCF data accumulated since CE marking
Insufficient clinical expertise of evaluator	CV not included; evaluator lacks relevant clinical background

CER update frequency

Class	Minimum update frequency
Class I	When significant new data available or device changes
Class IIa	When significant new data available; consider annual review
Class IIb	At least annually
Class III	At 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

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

The qualifications section should be completed with: 'MDR Annex XIV §1 requires that the clinical evaluation is conducted by persons with appropriate scientific training and clinical or technical expertise in the medical device field or the clinical discipline relevant to the device. The clinical evaluator must be independent of the design and development function and possess the necessary knowledge to appraise clinical data critically and draw valid scientific conclusions. For devices in specialist areas (e.g. cardiology, neurology), clinical expertise in that specific area is required.'

What is the CER?​

CER structure — MDCG 2020-6 template​

Section 1 — Scope of the clinical evaluation​

Section 2 — Clinical background and context​

Section 3 — Device description relevant to clinical evaluation​

Section 4 — Clinical data — literature search​

Section 5 — Clinical data — clinical investigations​

Section 6 — Analysis of clinical data​

Section 7 — Clinical evaluation conclusions​

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

Section 9 — Date and version control​

Qualifications of the clinical evaluator​

Common CER deficiencies identified by notified bodies​

CER update frequency​

Related pages​

Official references​