By Robert Zott, Director of Advisory Services Development
Originally published November 13, 2018
There is now 1 year, 6 months and 20 days until the application date upon which the new European Medical Device Regulation (MDR) goes into effect. For those charged with the task of upgrading systems for MDR compliance, that’s 567 days or 13,608 hours. We are also receiving word from the field that Notified Bodies will begin requiring MDR-compliant Clinical Evaluation Reports (CERs) as early as March, 2019. In other words, the changeover to the MDR has begun and the time to act is now.
This article (part 2 of an ongoing series) examines the reporting of serious incidents and field safety corrective actions described in article 87. Get the article here.
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