The manufacturer of a medical device must produce a clinical evaluation report, CER, to document the clinical evaluation and its result.
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 the 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 sufficient detail to understand the search criteria adopted by the evaluators, the available data, the assumptions made, and all the conclusions reached.
WHAT MUST CONTAIN IN A CER
The report must describe the different stages of the clinical evaluation :
- Stage 0, the scope of clinical evaluation:
- explains the scope and context of the assessment, 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:
- explains the literature search strategy;
- presents the nature and scope of the 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 relevant data sets (methods, results, authors' conclusions);
- assesses its methodological quality, scientific validity, relevance for the evaluation, the weight attributed 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 the current knowledge of the state of the art
- identifies residual risks that need to be further assessed during the SMP and PMCF.
CER CREATION
It is a “live” report throughout the life of the product. Every time new data emerges in post-marketing surveillance (PMS) that may influence the CER findings, it must be modified.
Evaluators must verify the clinical evaluation report, verify that it includes an accurate statement of their analysis and opinions, and sign the report.
They must provide their CV and declaration of interest to the manufacturer. The report must be dated and version-controlled.
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