Literature Reviews

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).

MDD 93/42/EEC requirements effective March 2010 heighten the expectations regarding Clinical Evaluation Reports and the literature reviews that support them. Here are some helpful resources:

TUV Product Services has a Med-Info document summarizing new expectations. Click here to access.

MEDDEV 2.7.1 Rev 3 (December 2009) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. Click here to access.

MD&DI January 2010 article on this topic. Click here to access.

Literature Review Procedure

If you plan to tackle the project yourself, click here to access helpful advice in this article written by Barb Danson and published in MD&DI magazine:

Danson, Barb. “Seven Steps to Systematic Literature Reviews.” Medical Device & Diagnostic Industry. Feb 2007. 29(2):46-53.

 

*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 latest release of MEDDEV 2.7.1, so make sure to review Rev 3 of that guidance.