In the second post of our Post Market Surveillance series we’re going to dive into incident reporting and vigilance. This section of MDR deals with how your firm monitors for and then responds to any events reported by various competent authorities where your product is sold.
As mentioned in part 1 of this series, incidents and safety corrective actions must all be reported by the manufacturer upon their occurrence. The specifics of which incidents need to be reported and how quickly vary by device classification and type of incident. Theses specifics will be the focus of this article.
Annex III of 2017/745 contains the technical documentation that is outlined in the preceding regulation articles addressing post market surveillance.
Here are the exact deadlines mentioned in the regulation (Article 87)
15 days for a Serious Incident
A serious incident is defined as something that is NOT an expected side effect or clearly documented technical issue of the product. You are required to report the incident immediately after establishing a relationship with your product, and not later than 15 days of ‘becoming aware of the incident’
2 Days for a Serious Public Health Threat
If an incident related to your product is considered a ‘serious public health threat’ then you must report on it within 2 days of becoming aware.
Paragraph 1 section B States that any field safety corrective actions must be reported. It also states that these include FSCAs of related products in third countries. So if an equivalent device is recalled in a non-European union country, it would appear that it is your responsibility to report the incident additionally.
What’s interesting about Article 87 is that these requirements of reporting all based on when the manufacturer becomes aware of the incident. They do not specify any guidelines or requirements for how long that process should take.
This appears to be one of the more ambiguous pieces of your overall Post Market Surveillance system that should be addressed. It would certainly strengthen your submission to your notified body if you had in place a plan for proactively finding and evaluating these incidents as close to their publication time/date as possible.
If you have unique product offered in few countries, this process may be very manageable by subscribing to adverse event alerts (if the country in question has an automated notification system in place). However, if your product is more common and may have several equivalent devices marketed throughout the world, then the matter of compliance with this article becomes more challenging to manage.
The best thing you can do to make your team aware of incidents is subscribe to as many as possible. At CiteMed, we built a system that aggregates all global incident lists (that are publicly available) to ensure we never miss any that apply to client’s products. For your market it may be possible to simply go down the list of adverse event databases and compile your own lists routinely for assessment.
Whether you choose to use a system or task human capital to routinely monitor and respond the important thing is that your plan is presented in a way to inspires quality and consistency.
Next we will go over a Post Market Safety Update Report, what’s required of them and how we personally approach the challenge of delivering a comprehensive report that’s consistently updated over time.