Thing to Look for to Comply with EU MDR Literature Review

According to the EU MDR, there are some important things that notified bodies look for in medical device literature reviews. EU Medical Device Regulation compliance on is around the corner, so it is good to adopt best practices to ensure your literature reviews are compliant. You can do this by aligning them with the MEDDEV 2.7/1 rev 4. It has become increasingly vital to adopt a reproducible and transparent literature review process to meet the new regulations’ requirements effectively. It can, however, be difficult to achieve this with spreadsheets or manual data management. If you ensure that your process adheres to the best practices, you will easily provide the documented evidence that these bodies want to see. Here are some of the pieces of evidence they will want to see.
Databases Used
The regulation MEDDEV 2.7/1 rev 4 specifies both Embase and MEDLINE. It is considered best practice to have both databases to ensure that you have located all potentially relevant literature.
Excluded and Included Reference Lists
Notified bodies will look for the studies that have been excluded or included. Recently, they have gained interest in ensuring that the reasons you give for exclusions are legitimate. You have to take care to ensure your literature review not only captures but also retains the information for the purposes of reporting.
Searched Output
The records that you have should be well maintained and contain all the literature returned by the search. This will allow a notified body to have confidence that all potentially relevant articles were considered for inclusion in the literature.
Search Strategy
If your search question is well-defined, it will provide the foundation for the whole process of literature review. If your search is not effectively completed, the quality of whatever will do on the review will suffer. Therefore, you must make sure that your search question is clear, the search is done systematically, and your search strategy is well documented.
These are some of the things that you will expect the notified bodies to look for in your literature. To establish a state of the art in your medical device clinical evaluation report, make sure you have these vital elements in mind and put everything in order.…