Post Market Surveillance in MDR
There are only a handful of explicit things that you HAVE to do under MDR for PMS, however there are a lot more things you SHOULD be doing to continuously monitor and update your products’ risk-benefit analysis.
Because of the broad sweeping nature of these regulations, it’s vitally important that your company has in place a robust PMS system that will hold up to Notified Body Scrutiny. Let’s take a look at the various topics pertaining to PMS in the Regulation and how your company might approach each one.
This post (Part 1) will cover an overview of the various applicable articles on Post Market Surveillance and how you might go about crafting your Post Market Surveillance Strategy to satisfy all new requirements without any question.
Post Market Surveillance is a big topic, so for this series we will first review the major components referenced in Regulation 2017/745 and then go into detail on each individual topic this week.
Adverse Event Monitoring
It is vital that you monitor adverse events across as many nations as possible where your device or equivalent versions are sold. This is the ‘reactive’ part of your strategy and falls under Post Market Vigilance.
Under MDR you must monitor for incidents involving your product and then respond differently based on the level of incident (complaint vs. serious injury vs. death). If an FSCA is published within the EU about your product then it’s necessary to file a report with your Notified Body as soon as possible.
Trend reporting is specifically mentioned in Article 88, and has to do with the frequency of reported incidents referring to your device. The bottom line of this Article is that responsibility falls on the manufacturer to assess the number of occurrences and make a judgement as to whether an increase in adverse events is significant enough to alter the benefit-risk analysis determination of their product.
With a systematic approach to adverse event reporting, trend reporting is merely an analysis of the adverse event data you should already be collecting and reviewing.
The Main Pillars of Post Market Surveillance
Updating the benefit/risk determination
Benefit-risk determination is created during your initial CE Marking filing, and must be diligently updated over time. This is achieved by taking in all relevant data (Scientific Literature, Adverse Events and Technical Product Updates) and critically assessing whether the introduction of new information on your product has changed your previous assessment.
The more frequently this is updated the better. We recommend annual updates for all products (though for some it is absolutely required by MDR)
Performance Evaluation – Clinical
By reviewing all current (and new) scientific literature you can further the case for your product’s efficacy in the current marketplace. The more evidence you can gather the more high performance can be justified while simultaneously being beneficial to your benefit-risk assessment.
Summarize New Safety Information that has surfaced
Good Post Market Safety Updates should contain summaries and commentary on all adverse events that apply to your product. If possible this should be comprehensive across all nations where your product (or equivalents) are sold.
Documenting Your Process
It’s important to put a system in place to not only conduct post market surveillance but also to document the steps your company has taken to continuously evaluate your product.
We believe that a Literature Search across multiple Scientific Database and all Adverse Event Databases is the absolute best way to concisely meet your Post Market analysis year after year.
Use Technology to Ensure consistency
If your company is currently planning on doing post market follow-up and research manually we urge you to take a look at the hard reality. Your regulatory/compliance team is likely already overburdened just keeping up with new product filings, let alone remembering to do their routine checks of existing products year after year.
Our use of technology to keep track of a re-run Literature Searches annually ensures that your PMS is completed consistently.
Next we will take a look at serious incident and field safety corrective action reporting and outline a strategy to meet the MDR requirements for your devices.