Post Market Surveillance
Getting the basics right
MDR for Post Market Surveillance only requires a few specific actions, but you should take many more to regularly evaluate and improve your product’s risk-benefit analysis. As a starting point, it is important to distinguish between QMS, PMS versus PMCF, and where all systems sit. In Figure 1, it shows that the QMS underpins the process, and the PMS process sits within this. We can then divide Post Market Surveillance between reactive and proactive PMS.
- ‘Reactive’ PMS responds after an event, ranging from complaints to major injury or death (vigilance). We call these activities ‘passive’ because they mostly collect data.
- ‘Proactive’ PMS tries to foresee and prevent problems.
Table 1: Examples of PMS data and their respective action types
Proactive
- Customer Surveys
- Post CE Mark Clinical Trials, including PMCF
- Manufacturer Sponsored Device
- Tracking/Implant Registries
- Expert User Groups (Focus Groups)
Reactive
- Customer Complaints
- Unsolicited User Feedback (Other Than Complaints)
- Maintenance/Service
- Reports In-House
- Testing (Routine)
- Failure Analysis
- Social Media
- Literature Reviews
- Regional or National Device Registries (Non-Manufacturer Sponsored Trials)
Due to the complexity of these requirements, your organisation needs a Post Market Surveillance system that can withstand Notified Body scrutiny. Let’s examine the themes of the PMS Regulation and how your company might address them. Post Market Surveillance is a broad topic, so we’ll cover the basics of EU MDR 2017/745.
Document Control and Audit Trail
It’s critical to set up a system that allows you to track post-market monitoring and the actions your organisation has taken to continuously analyse your product. Conducting a literature search across scientific databases and adverse event databases is the most efficient Post Market GSPR analysis method year after year.
Adverse Event Monitoring
In all distribution countries for your equipment or identical versions, it is critical to monitor adverse events. Post Market Vigilance is the ‘reactive’ portion of your approach. MDR requires manufacturers and their economic operators to monitor for product issues and respond accordingly (complaint vs. serious injury vs. death). Upon publication of an FSCA about your product in the EU, you must notify your Notified Body immediately. You must show in audits that your PMS can identify product problems and report serious adverse events in time.
Updating the Benefit/Risk Determination
You prepare the benefit-risk assessment during the original CE marking application, and you must update it regularly. You can do this by examining all relevant data (scientific literature, adverse events, and technical product upgrades). Then you need to see if it changes your previous assessment. Keeping your State of the Art write-up current and examining all new scientific publications supports your CER that your product meets the General Safety and Performance against similar devices in the current marketplace. The more proof you can collect, the higher performance may be justified, while also benefiting your benefit-risk analysis. You need to ensure your PMS plan states that you will report new safety information in quality/safety meetings, PMSR/PSUR, and CER.
Trend Reporting
Article 88 mentions trend reporting, which is the frequency of recorded incidents involving your equipment. The manufacturer has responsibility to examine occurrences and decide if an increase in adverse events changes their product’s benefit-risk analysis. Trend reporting is just an examination of the adverse event data you should already be gathering and evaluating if you take a systematic approach to adverse event reporting.
CLIN-r+ Recommendations
- If your organisation is currently going to undertake post-market follow-up and research manually, we strongly advise you to consider we strongly advise monitor workloads to retain Your regulatory/compliance team is most likely already overworked just keeping up with new product filings, let alone remembering to conduct annual product checks.
- Compile a list of any new safety information that has been found. All adverse occurrences that apply to your product should be summarised and discussed to be considered a good PMSR/PSUR. If at all possible, this should apply to all countries where your goods (or analogues) are.
- Consider outsourcing the vigilance database reports to save time and internal.
- Invest in a well-designed PMS plan where your reporting templates and data collection templates is well made to save you time to make the processed easy to implement, easy to train new staff with uses automation of trending and data summary generation to make reporting live and quick.
- Consider outsourcing your systematic literature reviews if you’re not investing in software or extending your Clinical Affairs This ensures that your literature is available on time with updating your CER and PSUR.
To learn more about CLIN-r+ services for medical devices and IVD manufacturers, get in touch!
Quality Management System (QMS)
Clinical Evaluation for Medical Devices
