Clinical Evaluation Report (CER) comprises of three major parts that present complete clinical evaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of the medical device along with compliance and experience records. The third part of the CER deals with the literature review of the clinical evaluation published on equivalent devices.
A literature review may form the major source of clinical evidence to validate the safety and performance of the established devices in their commercialization approval process, where it may not be feasible to conduct new clinical investigations on the device.
Purpose of Literature search in Clinical evaluation
A well-conducted literature search can reduce the need for generating relevant data through clinical investigation of the medical device under consideration. Therefore, a good database search knowledge is mandatory (e.g. MEDLINE or Pubmed, EMBASE, Excerpta Medica, the Cochrane Central Trials registries, WHO International Clinical Trial Registry Platform (ICTRP) and Clinical Trials.gov) Experts who are well versed in conducting systematic review would adopt sound non-biased methodology using PICO or PRISMA or MOOSE guidelines to review methods pertinent to the literature review questions.
The important objectives of the literature review are to
- Provide an overview of the performance and intended use of the device through a report of past clinical trials.
- Establish that the particular medical device is broadly similar to another equivalent device in the market
- Validate that the safety parameters of the device under the close monitoring of the clinical investigator
- Establish that the particular device is highly safe for use in the day-to-day healthcare delivery field.
The clinical evaluation plan needs to specify the selection criteria of the relevant publications to tackle the literature review questions. It shall contain a decisive review of the pertinent scientific literature along with the list of literature reviewed and relevant unpublished data about the particular medical device. A good review of appropriate literature relating to the intended use and planned method of use of the medical device is considered significant by the concerned regulatory authorities during the conformity assessment process.
European Regulatory guidelines on Literature Review
The European Commission provides a series of guidance documents to assist medical device manufacturers and other stakeholders in implementing the set directives related to marketing medical devices in the European Union region. Revision 4 of the guidelines provides detailed information regarding the literature review process for clinical evaluation that includes the directions and the methods to do a relevant literature search, appraisal and search strategies. The CER needs to have the analysis of data arrived from literature review, results of assessment strategy and the functional list of publication references used in the literature search for clinical investigation.
European Regulatory Framework has established that a well-conducted literature review is significant to
- Ascertain whether a clinical investigation is needed for the medical device under consideration.
- Make a justification for the clinical study, if considered necessary.
- Arrive at a conclusion as to whether the particular medical device is ready for commercialization.
A professional literature search conducted with the use of biomedical literature database that contains up-to-date and deeply indexed information can lead to a comprehensive report, which has complete information relating to the comparison of similar devices, device economics, and adverse device events. The medical device manufacturers can acquire expert assistance from seasoned professionals to create a comprehensive Clinical Evaluation Report that will facilitate them to obtain regulatory approval in a prompt manner.
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