The EU Medical Devices Regulation (MDR) requires clinical evaluation reports (CERs) to provide valid and reliable evidence to demonstrate the safety and performance of a medical device before it can be placed on the EU market. Literature is an important source of evidence for these reports and provides a wide range of evidence, including evidence of clinical performance, safety, and effectiveness.
Systematic literature reviews ensure that all relevant evidence is identified and considered in the CER. This helps ensure the overall reliability and validity of the evidence used to support the safety and performance of the medical device.
Systematic literature reviews should use multiple databases to ensure that as many relevant sources as possible are included in the review. This allows the researcher to have access to a wider range of sources, including both published and unpublished material. It also helps to provide a more comprehensive and accurate picture of the current state of the literature. Additionally, some databases may have more comprehensive coverage in certain areas than others, hence using multiple databases can help to ensure that no relevant sources are missed. Having an insufficient number of literature sources in the CER is a common observation in Notified Body assessments.
There are several scientific research databases with either free or paid access that one can consider as data sources for literature in a CER.
Europe PMC is a free, open access resource for the scientific community, providing access to millions of research articles from thousands of journals. It is the most comprehensive source of research literature in Europe, with over 41.9 million publications, preprints and other documents with links to supporting data, reviews, protocols, and other relevant resources. Europe PMC provides a single point of access to the abstracts available through PubMed, PMC full-text articles, and an additional 5 million other relevant resources, such as patent records.
Europe PMC is integrated within the CAPTIS platform, i.e., users can search the database directly via the CAPTIS search module. The platform also provides a direct link to the search database with the search string created by the user. If you conduct your literature searches through CAPTIS, all search elements including the date of the search, filters used etc. are recorded by the platform and a search strategy is automatically documented within your project. This strategy is available in the form of a report which can be easily plugged into your clinical evaluation report, performance evaluation report or any other document utilizing a literature review. This integrated search feature helps save time by providing users with easy access to all the information they need in one place.
CAPTIS imports all article identifiers like the article title, authors, publication details, abstract, and links to the original Europe PMC article automatically. In addition to that, it also deduplicates the list of articles for you; hence, there are no secondary exports or steps required to fully document the process and users can begin their literature evaluation immediately. CAPTIS handles the mundane aspects of a literature search for you, so that you can focus your time on the actual analysis involved in the systematic literature review.