Electronic Adverse Events Reporting What Does It Mean To You

As new regulations and legislation regarding eMDR (Electronic Medical Device Reports) and eMDV (Electronic Medical Device Vigilance Reports) have been forming, medical device companies have been scrambling to get a handle on how exactly to act. Being inundated with lengthy documents and incomprehensible jargon certainly does not make the task any easier. Without a compliance handbook many misconceptions have formed in the confusion and even more companies hardly know where to begin. With a few tips, some shared knowledge and helpful resources, we are here to help.

The first and most important compliance issue deals with reporting MDR information. Unbeknownst to many, every regulatory agency offers their own reporting tools, completely free of cost, and separate from paper submissions. In the US, companies can access the FDAs reporting tool online, enter their MDR information, and electronically submit. Following the submission, the FDA will then acknowledge receipt of the file, and inform you of whether or not it has been accepted. In the event that your data is not suitable, you will then have 30 days to resubmit a revised copy of the MDR information.

Ironically, where in most situations electronic reporting would be preferable to paper submissions from any angle, the FDAs electronic submission system actually requires more work and introduces new opportunities for rejection of the MDR data. In an effort to combat the less than ideal reporting systems regulatory agencies have to offer, companies have begun to implement their own commercial systems to submit MDR information. In many cases these systems have proven effective in reducing risk by generating and submitting compliant reports, and they have in turn cut costs. Paper submission may appear to be a cost effective option but when considering the manpower, time, and lost productivity that it incurs, an eMDR system is typically preferable. Instead of weighing the costs of paper MDR submissions to manual systems provided by regulatory bodies, compare the costs and benefits of regulatory manual eMDR and automated eMDR. The results may be surprising.