When the pending FDA rule is finalized it will require more than 56,000 medical device importers, manufacturers and other medical device facilities/professionals to submit medical device reports (MDRs) in an electronic format (otherwise known as electronic medical device reports (eMDRs)). eMDRs have been an option for medical device companies for a few years but this ruling—once finalized—will result in very significant changes that will be required by law for all medical device companies that seek to market products in the USA.
Said changes will present several challenges, specifically: breaking the habit of the traditional paper-based MDR management that exists in many medical device environments and implementing the conversion from paper to electronic management within the time frame in which the conversion from paper-based to electronic management is expected to occur; it is likely for example that device manufacturers and importers will have approximately one year for conversion before compliance with the new electronic standards requires fulfillment.
The European Medicines Agency (EMEA) will also expect MDRs to be submitted in an electronic format once the ruling is finalized. Combined electronic document, training and complaints management software will likely be in demand for medical device companies in the very near future.