Clinical Evaluation and Literature Search Requirements
The Clinical Evaluation Literature Search guides how to identify and evaluate the clinical data through literature searches that are needed for the clinical evaluation. This applies to all literature searches conducted for the medical device manufactured and sold by a particular manufacturer name as a part of Clinical Evaluation. The standard followed is (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices- Chapter VI, Article 61 & Annex XIV (Part A) – and guidance document MEDDEV 2.7.1 Rev 4 for Clinical Evaluation.
Know more about Clinical Evaluation Report
MDR General Requirements
The details of the device under evaluation should be completely understood before starting the literature search.
The intended purpose, use environment, user population and patient population should be well known and recorded in the search report.
The relevant scientific literature should be critically evaluated for the clinical safety, performance, design characteristics and intended purpose of the device under evaluation.
How to do a Literature Search Plan
The search plan should be developed and executed by persons with expertise in information retrieval, having due regard to the scope of the clinical evaluation set out by the manufacturer.
The plan should describe the device details, period of search, persons involved in the search, sources of search and possible keywords for search.
It should also include information on the inclusion and exclusion criteria based on the device’s intended purpose, mechanism of action and technology adopted.
What are the main Sources of Literature?
Among the different sources of clinical literature, a comprehensive search strategy in multiple databases must be followed. An appropriate and maximum number of relevant keywords should be used on the different sources of search.
· Sources of Literature include,
· Scientific Literature Database
· Internet Searches
· Non-published data
· Citations referenced in scientific literature.
The search strategy should be documented and justified.
A. Scientific Literature Databases
· Start the search with MEDLINE or PubMed.
· Additional databases such as European PMC shall be searched to ensure the adequate coverage of devices and therapies in use in Europe, to identify relevant clinical trials and publications of user experience.
· Progress the searches by device name and manufacturer (e.g. EMBASE (biomedical literature database) /Excerpta Medica, the Cochrane CENTRAL trials register, etc.).
· Due to frequent changes in information coverage and search features available in scientific databases, the criteria for selecting adequate databases therefore must be defined and re-evaluated regularly.
B. Internet Searches
The important data on the device under evaluation can be obtained through internet searches as follows,
· The harmonized standards and other standards applicable to the device in question and containing information on clinical performance and clinical safety.
· Field safety corrective actions for the equivalent and/or other devices shall be found on the manufacturer’s websites, internet sites of European Competent authorities, the U.S. Food, and Drug Administration (FDA), and other possible sites.
· Implant registry reports.
· Some Documents should be in systematic review databases (e.g. the Cochrane Database of Systematic Reviews, Prospero International Prospective Register of Systematic Reviews).
· The expert documents for the assessment of current knowledge/ the state of the art must be produced by professional medical associations, including clinical practice guidelines and consensus statements.
· Meta-analyses and reviews of health technology assessment (HTA) institutes and networks.
· Identification of studies via the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov.
C. Non-Published Data
The retrieval of non-published data is important for many devices for monitoring any changes, e.g.
· The label and IFU of the equivalent device (the equivalence should be claimed by the manufacturer) and/or of benchmark devices and other devices.
· Data provided to manufacturers from implant registries.
· Data presented at congresses.
D. Citations Referenced in Scientific Literature
· Important and relevant citations referenced in the scientific literature should be considered and screened by the manufacturer.
· Manufacturer must retrieve some of the referenced literature which must be followed to appraise the scientific quality of a document.
Background to The Literature Search and Literature Review
The Background must be the importance of and rationale for the literature review and should include, but is not limited to:
· Device name/model
· The literature review must provide data on current interventions1 for the intended patient population (state of the art) to give input to the assessments of acceptable benefit/risk profiles, what is currently considered as providing a high level of protection of health and safety and what are considered acceptable side-effects.
· Previous literature reviews
· Importance of review to risk management process
· Previous literature searches conducted by the manufacturer.
· If the equivalent or benchmark devices are included, the name and model of the devices.
· The Clinical Evaluation Report must establish equivalence to the device under evaluation or the relevance of benchmark devices to the clinical evaluation.
Process of Literature Search and Review:
· The selection of literature should be objective and justified, i.e. the selected literature should include all relevant data, both favorable and unfavorable. Concerning the clinical evaluation, the clinical evaluators must assess the degree to which the selected papers reflect the intended application/ use of the device.
Objective, non-biased, systematic search, and review methods should be used. Examples are:
· PICO Cochrane Handbook for Systematic Reviews of Interventions
· PRISMA Statement
· MOOSE Proposal
The kinds of literature obtained through the different sources should be critically evaluated for the safety, performance, design characteristics and intended purpose of the device under evaluation, where the following conditions are satisfied.
It should be demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relates.
The data adequately demonstrate compliance with the relevant general safety and performance requirements.
A critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted under Article 81, and Annex XIV of MDR.
Review the data availability of current alternative treatment options for the intended purpose, if any.
If the manufacturer holds its clinical data for the device in question (e.g. own premarket clinical investigations, PMCF Studies, other PMS data), the literature must be considered together with those data for consistent appraisal and overall analysis.
The literature on the device under evaluation, equivalent devices and similar devices must be included.
The inputs for the review question(s) (e.g. PICO) must be the device description and the intended performance of the device including any claims on clinical performance and clinical safety which the manufacturer wants to use.
The information from the risk management process must be used as input.
The number of literatures to be obtained is not limited, but at a minimum, it should contain 20 robust literatures related to the safety and performance of the device under evaluation.
How to prepare a Search Report / Output of Literature Search
· The relevant literature abstract should be included search output section of the search report. The abstract should describe the purpose, method, and results.
· The data relevancy in terms of intended use, user population, use environment, patient population, safety and performance of the literature data to the device under evaluation should be provided.
· The current knowledge/ the state of the art must be provided for the proper conduct of the appraisal and analysis of the clinical data of the device under evaluation and the equivalent.
· The literature collected should be related directly to the device in question (e.g. publications of clinical investigations of the device in question that have been performed by third parties, its side effects or complications, incidence reports) and/or to the equivalent device, benchmark devices, other devices, and medical alternatives available to the intended patient population.
· Any deviation that happened from the search plan should be recorded in the search report.
The overall conclusion of the literature output should be mentioned, and it should satisfy the clinical safety and performance of the device under evaluation by itself.
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