Literature reviews are labor-intensive projects that can require a large investment, especially for start-up medical device companies. When performed carefully and methodically, the investment pays off because literature reviews provide critical input to clinical protocols and reports, marketing documents, regulatory submissions and the product development process (e.g., product hazard and risk analyses).
Here are some helpful resources:
MEDDEV 2.7.1 Rev 4 (June 2016) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies
bsi The top ten changes in MEDDEV 2.7.1 Rev 4
TUV FAQs about the Medical Device Regulation (MDR)
Literature Review Procedure
If you plan to tackle the project yourself, click below for an article written by Barb that describes a systematic process for conducting literature reviews.
*Note: Since publication of this article, I’ve streamlined my process to, in most cases, combine the data summary table and data analysis spreadsheet into one document. This article was written prior to the MDR and the latest release of MEDDEV 2.7.1, so make sure to review the current regulation and guidance.
