In our first post on literature reviews for medical device clinical evaluation reports (CERs), we looked at the importance of multiple databases and using refined, comprehensive search strategies to create literature reviews that are compliant with the upcoming Medical Device Regulation (MDR) 2017/745 and follow the MEDDEV 2.7/1 Revision 4 guidelines. Our conclusion was that searching the broadest content set possible helps ensure both compliance and comprehensiveness, while the use of precision search coupled with accurate synonyms expands the number of meaningful results available. In this post, we explain how to deliver efficient EU MDR literature reviews in order to minimise the time, cost and administrative burden relating to MDR 2017/745 compliance.
The case for efficient EU MDR literature reviews: simplifying a complex process
CER literature reviews present device manufacturers with a complex task. First, they require searches for multiple sections: current knowledge and state of the art, clinical literature and post-marketing surveillance. Different strategies are needed for these different searches: current knowledge and state of the art are broad comparison searches looking for the most recent information in the field, while clinical literature and post-marketing surveillance searches look specifically at a manufacturer’s own devices.
And literature searches need to account for all references, be quality-appraised, include full texts and summaries in a table and explain their rationale for included and excluded literature.
The CER Literature Review Protocol requires an objective research question, for example using PICO and PRISMA, searches that can require specialist expertise to set up. MDR 2017/745’s requirement for more transparency creates increased reporting obligations for manufacturers and economic operators throughout the medical device life cycle, which means that reviews have to be conducted over longer time periods. MDR 2017/745 also requires manufactures to evidence the methodology for their literature search, so a clear and detailed record of each strategy is essential.
Four ways to deliver efficient EU MDR literature reviews
1. Use saved searches and alerts
Proper management of complex search strategies with sort, filter, edit and sharing tools makes it easy to maintain literature review searches on a range of medical devices. When a manufacturer conducts literature reviews across many devices, this results in one or more search strategies for each device. The ability to simultaneously update these searches (which may be similar) with the same change saves significant time. Automated notifications, also known as alerts, can deliver new clinical data on devices on a regularly scheduled basis as it becomes available. This is particularly valuable now that devices have to be monitored over their entire life cycles.
2. Maintain a record of alert strategies
Keeping a record of clearly documented alerts provides an essential audit trail for MDR 2017/745 compliance. In Dialog, the audit trail is for the lifetime of the alert plus four years. The audit trail can include all changes and the full history of alert deliveries. Having these finer details automatically stored and available at any time provides thorough documentation when needed.
3. Reach out for help with search strategies
CER literature review strategies need to follow specific frameworks such as PICO or PRISMA and to follow consistent methodologies. Setting up these searches in a way that works for you needs a tool that offers a combination of flexibility and precision. It may also be helpful in some cases to look for professional help setting them up.
4. Look for flexible pricing
Depending on the number of devices they need to monitor, manufacturers may need the flexibility of subscription- or usage-based pricing. And with MDR 2017/745’s requirement to provide full-text articles as part of CERs, they may need to balance the cost and practicality of using or maintaining their own libraries with economies of scale that third-party vendors can offer. Dialog, for example, offers an integration with Article Galaxy that provides cost-efficient access to a library of full-text PDFs.
