By Robert Zott, Director of Advisory Services Development
Originally published September 10, 2018
At the time of this writing, there is 1 year, 8 months, and 18 days—that’s 626 days or 15,024 hours—before the new European Medical Device Regulation (MDR) will become the law of the land. For those affected by the tighter scrutiny of high-risk devices, changes in classification or the technical challenges of unique device identification, layers of complexity will be added in the name of safety to an already-burdensome process. But the one subject on the minds and hopefully the agendas of nearly every quality and regulatory professional is the codification of requirements for Post-Market Surveillance (PMS): the system, plans and reports that proactively collect and review experience from devices in the field. It is your eyes and ears, monitoring for signs that immediate corrective or preventive actions must be taken, and it is without question the most critical feedback mechanism in all of medical device regulation.
This article (part 1 of a 3-part series) takes a closer look at the requirements for the PMS system. Get the article here.
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