By 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 documentation requirements for PMS (Annex III). As the countdown continues, there is now 1 year, 3 months and 14 days until the May 26, 2020 application date that shall bring the MDR into effect. As the date approaches, we have observed an escalation in the number of companies ramping up their PMS activities and urgently seeking audits.
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- 88By 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…
- The New Post-Market Surveillance Regulations for Europe, Part 2: Serious Incidents Get A Serious Overhaul.84By 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…
- 64When it comes to the new European Medical Device Regulation (MDR), it’s critical to know where you stand. Take a look at the MDR timeline here.