CER CLINICAL EVALUATION REPORT

 The manufacturer of a medical device must produce a clinical evaluation report, CER, to document the clinical evaluation and its result.

The MEDDEV Guideline 2.7/1 rev.4 defines clinical evaluation as a procedure that involves the collection, estimation, analysis and evaluation of available clinical data to support compliance of the medical device with the Essential Requirements.

The clinical evaluation report or CER must contain sufficient information to be read and understood by an independent agent. You must provide enough detail to understand the search criteria adopted by the evaluators, the data available, the assumptions made, and any conclusions reached.

WHAT SHOULD A CER CONTAIN

It is important that the report describes the different stages of the clinical evaluation:

• Stage 0, scope of clinical evaluation:

– explains the scope and context of the evaluation, the technology on which the medical device is based, the conditions of use and the intended purpose of the device;

– documents any claims made about the clinical performance or clinical safety of the device.

• Stage 1, identification of relevant data:
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– explains the literature search strategy;

– presents the nature and extent of clinical data and relevant preclinical data that have been identified.

• Stage 2, assessment of relevant data:

– explains the criteria used by the evaluators to evaluate the data sets;

– summarizes the relevant data sets (methods, results, authors' conclusions);

– assesses its methodological quality, scientific validity, relevance to the assessment, the weight given to the evidence, and any limitations;

– presents justifications for rejecting certain data or documents.

• Stage 3, analysis of clinical data:

– explains whether and the referenced information and clinical data constitute sufficient clinical evidence to demonstrate the intended use and clinical safety of the device under evaluation;

– explains whether adequate data exists for all aspects of the intended purpose.

– describes the benefits and risks of the device

– explains the acceptability of the benefit / risk ratio according to current knowledge of the State of the art

– identifies residual risks that need to be further assessed during the SMP and PMCF .

CREATION OF THE CER

It is a “live” report throughout the useful life of the product. Every time a new post- marketing surveillance (PMS) data emerges that could influence the CER findings, it should be modified.

Evaluators must verify the clinical evaluation report, provide verification that it includes an accurate statement of their analysis and opinions, and sign the report. They must provide their CV and declaration of interests to the manufacturer.

The report must be dated and version controlled.