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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- The New Post-Market Surveillance Regulations for Europe - Part 3: Trending, Analysis and Documentation84By Robert Zott, Director of Advisory Services Development Originally published February 15, 2019 In this final installment of the new Post-Market Surveillance (PMS) requirements from the forthcoming Medical Device Regulation (MDR), we’ll examine trend reporting (Article 88 of the MDR), the analysis of serious incidents and field safety corrective actions (Article 89), and the technical…
- 82By 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…
- 78By Robert Zott, Director of Advisory Services Originally Published: July 18, 2018 The publication of the new Medical Device Regulation (MDR) 2017/745 in the European Journal, with its entry into force on May 25, 2017, marks the end of an eight-year period of controversy, and the beginning of a three-year transition to the most sweeping…