21 CFR 803 Gap Analysis
Is a quick reference tool compares the new medical device reporting regulation to the old regulation.
An excerpt from our blog, “A Gap Analysis Tool for Updating Your Medical Device Reporting Procedure.”
Comparison of Current & New 21 CFR 803 Regulations
“The first step in understanding the specific changes to the regulation is to compare the old and new versions. The new Part 803 regulation for MDR was released as a PDF document, and therefore it does not lend itself to a direct comparison with the previous version of the regulation. Therefore, Medical Device Academy downloaded the new regulation (http://bit.ly/udpated-21CFR803), and copied and pasted each section into a Word document. We also did this for the current version (http://bit.ly/Old-21CFR803). Then, we compared the two Word documents electronically. Finally, we wrote a gap analysis to summarize the differences between the two documents.” To download this gap analysis, please fill out the information box on this page.
Gap Analysis of Your Medical Device Reporting Procedure
“After you download the gap analysis tool that Medical Device Academy created, then you need to perform your own gap analysis of your current MDR procedure against the changes in Part 803. You should create a table with one column identifying the section of the regulations, a second column identifying the section(s) of your current MDR procedure that meet the requirements, and a third column to identify changes that need to be made. You might consider adding additional columns for delegating the responsibility of revising various sections of your procedure, and implementing other tasks listed below (e.g., obtaining an account for ESG).”