• Blogger, Featured Blogger, Medical Device
• by Tim.Mohn
• Jul 6, 2011
• No Comments

As the regulatory landscape evolves and medical device companies look for guidance about Electronic Medical Device Reports (eMDR) and Electronic Medical Device Vigilance Reports (eMDV), I’ve found there are many misconceptions about how to comply with new regulations and even uncertainty about  how to get started.   In my upcoming posts, I’ll share some of the best practices I’ve gleaned from my field and product work and will also provide my favorite resources for additional help.

The first thing to understand about eMDR and eMDV before launching into a discussion about EQMS is that every regulatory agency provides a free, low-volume manual reporting tool.  I’ll use the FDA as an example in this post, but similar options are available in EMEA and beyond.  For reporting in the United States, any company can login to a website called WebTrader and manually enter MDR information into an electronic form and submit it to the FDA.  Following this submission, the organization must check back for three separate notifications called acknowledgements, which confirm the organization’s file was accepted.  The FDA does not consider an eMDR to be ‘received’ until all 3 acknowledgements were successful; if any fail the firm must correct and resubmit within the same 30 day window.

As you can see and contrary to popular belief, this electronic option actually requires more effort and introduces new failure modes as opposed to the ‘paper’ MDR process. Consequently, many companies have found significant business benefits, both in cost and compliance risk, by implementing commercial systems that create the reports and submit them electronically as opposed to using the manual options provided by regulatory bodies. Firms sometimes make the mistake of comparing a software investment to the cost of doing business today in the paper MDR environment.  A better evaluation would be to evaluate today vs. ‘manual’ eMDR vs. ‘automated’ eMDR to see which provides the best option for your organization.

Stay tuned for my next post, where I’ll address how medical device companies can determine how their current complaint handling process is working and review a tool that can help companies determine the business implications of manual vs. automated e-reporting in their specific company.