I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well. FDA: Medical Device Reporting / adverse event?ROW: Vigilance Requirements / incident?
I've seen companies try to combine multiple jurisdictions' adverse event reporting requirements into a single universal set of criteria and terminology. But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions. Accordingly, my generally preferred approach is to keep the reporting thresholds and terminology for each jurisdiction separated from the others. This is done by way of a separate SOP / WI for each jurisdiction. A few examples are:U.S. FDA: Here, FDA's Medical Device Reporting (MDR) regulations expect that all "complaints" and "adverse events", as officially defined by the FDA, be screened using FDA's MDR reportability criteria, which lead to still other officially-defined FDA terms. In fact, FDA is so strongly committed to ensuring we use their terms, that you can find FDA Warning Letters citing failure to include FDA's specific terms in the firm's MDR reporting SOP. The FDA's reporting criteria and regulations don't use language like, "incident", "serious incident", "vigilance", etc. Moreover, FDA's reporting thresholds contain unique attributes not directly reflected in those of other jurisdictions.European MDR/IVDR: Here, the requirement is to report "serious incidents". The requirement is to screen any "incidents" to determine if they are "serious incidents", and then if so, a serious incident report must be made. The term "vigilance" reporting has strong roots in the European jurisdiction. The terms "incident" and "serious incident", along with related terms like "serious public health threat", have officially-defined meanings for Europe's Union; and those meanings don't always align with the terms / concepts / reporting thresholds used by other jurisdictions. To make things even trickier for Europe, they also officially define and use the reportability terms "adverse event" and "serious adverse event". But when using those, it is only in regards to devices in clinical investigations.Canada: Here, "incidents" that meet certain reporting criteria (see CMDR sections 59 -61 subparts) shall be reported. While the CMDR don't officially define "incident", Health Canada does define this informally via guidance. My experience with Health Canada inspections is that they will enforce the parameters of their guidance documents as if they were regulations; so be sure you incorporate those into your procedures. On that note, your procedures might still refer to Canadian "Mandatory Problem Reporting". That Canadian terminology was recently retired and replaced with the term "incident reporting".UK and Australia: These have used terminology modeled after the retired EU MDD/IVDD approach which were precursors to the current EU MDR/IVDR requirements.And so on.Again, my strong recommendation is to forego trying to universalize these different terms. Instead, we should have a dedicated reporting SOP/WI and decision tree form for each one. Hope this helps get you pointed in the right direction.
I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.FDA: Medical Device Reporting / adverse event?ROW: Vigilance Requirements / incident?
Hi StephanieI partly use Kevin's type approach. I have created a master SOP on Safety Reporting and defined terms in there and have a table an some high level text of each relevant countries' requirements. The SOP gets ong, but it is an awareness SOP for Management. Underneath that, for each country, as approval re gathered or nearing, and product will need written procedures for launch support, I create a RA Department level procedure, more on technical content of work instruction on exactly how to report.
I like this approach since my company is already accustomed to using a master reporting SOP. This way, significant changes don't overburden unnecessary personnel and training would be targeted to RA. Thanks!
Hi StephanieI partly use Kevin's type approach. I have created a master SOP on Safety Reporting and defined terms in there and have a table an some high level text of each relevant countries' requirements. The SOP gets ong, but it is an awareness SOP for Management.Underneath that, for each country, as approval re gathered or nearing, and product will need written procedures for launch support, I create a RA Department level procedure, more on technical content of work instruction on exactly how to report.
To add some more complications, at least FDA, if not other jurisdictions, expects you to report to their MDR system events that meet their definitions that occur on products that are distributed in US, NO MATTER WHERE THE EVENT OCCURS. So theoretically yo could have an event occur in Europe that has to be reported in US because the product was also distributed in the US.
Way to throw a wrench in my works Edwin. Hahha :) Just kidding. Thanks for the input!
I can see how creating more documentation does actually make things easier to use in this case. Thanks!
The terms "medical device reporting" and "vigilance requirements" are often used interchangeably, but they refer to different aspects of post-market surveillance and vigilance. Medical device reporting is a process in which manufacturers, importers, and user facilities report adverse events or incidents related to medical devices to regulatory authorities. Vigilance requirements are the obligations that manufacturers must follow to monitor the safety and performance of their devices after they have been placed on the market.
Regarding the terms "adverse event" and "incident," the EU Medical Device Regulation (MDR) uses the term "incident" (Article 2(64) MDR) to describe any malfunction, deterioration in characteristics or performance, use-error due to ergonomic features, inadequacy in the information supplied by the manufacturer, or any undesirable side-effect related to a medical device. In the US, the term "adverse event" is used in the context of medical device reporting under 21 CFR 803.
In summary, the terms "medical device reporting" and "vigilance requirements" are related but not identical, and the terms "adverse event" and "incident" are used differently in the US and EU regulations.
See:Medical Device Coordination Group (MDCG), MDCG 2023-3, Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices, Post-Market Surveillance and Vigilance (PMSV), Page, Paragraph 3.21 CFR 803, Medical Device Reporting.
The problem arises because regulatory regions have not harmonized the terms and their meaning.The FDA asks manufacturers to report "adverse events" following the "medical device reporting" system in Part 803. FDA asks for corrections and removals reports under Part 806.The EU, in the MDR, asks manufacturers to set up a "vigilance" system to report either "incidents" or "field safety correctives actions".The reporting requirements including timing and the information reported varies by regulatory region.Often companies will use generic terms for these activities, so conversation is easier. For example, one might ask if a complaint is a reportable event. The reporting criteria and the details reported may change, but specialists know what to do. Non-specialists who may encounter a problem, such as field service people, don't need to know the reporting details, only whether to raise the issue.<o:p></o:p>
Dear StephanieBased on the regional differences, recommend that your SOP (Standard Operating Procedure) is structured that there is a separate section for each country listing their terms, their definitions and their regulatory requirements to reflect the regional differences. With regards to these two topics, post-market surveillance and vigilance (i.e. no difference in context in some countries), the efforts of the IMDRF to harmonise regulation worldwide is really an important to make it easier in information sharing across regional boundaries. Best Regards,Stephanie
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