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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- The New Post-Market Surveillance Regulations for Europe - Part 3: Trending, Analysis and Documentation88By 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…
- The New Post-Market Surveillance Regulations for Europe, Part 2: Serious Incidents Get A Serious Overhaul.82By 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…
- 58By Robert Zott, Director of Advisory Services Development Originally published March 27, 2018 It’s easy to read Europe’s Clinical Evaluation Guidance Document MEDDEV 2.7/1 Revision 4 (referred to as “Rev. 4”) and come away with the impression that clinical data—whether in the form of investigations carried out by the manufacturer of a medical device or…