— coauthored by Jan Kloiber, Senior Principal Specialist and Celeste Maksim, Chief of Staff, Clinical and Post-Market Services
May 2022 is the one-year milestone for EU MDR and the date of application for IVDR. For medical devices that have already been approved under MDR, annual periodic safety update reports (PSURs) are due for Class IIb and III devices. Since this is the first year and there is still no official guidance, many manufacturers are struggling with meeting the new regulatory requirements.
Official MDCG Guidance will provide more details on what needs to be in the PSUR or post-market surveillance (PMS) report. The regulation gives a vague idea of the expectations but not specific details. In the meantime, manufacturers must make their best efforts to conform to the regulatory requirements.
PSUR/PMS Report Requirements Under MDR/IVDR
Requirements for post-market reporting under MDR/IVDR are more stringent and comprehensive than they were under MDD/IVDD. MDR and IVDR require manufacturers to collect post-market surveillance data (ie., feedback and information about similar devices) both reactively and proactively. Not all manufacturers are set up to proactively collect and analyze data efficiently, and some manufacturers aren’t prepared to do it at all.
Reactively Collecting Post-Market Surveillance Data
Manufacturers have mechanisms and processes in place for handling complaints, but the anticipated MDCG PSUR guidance is expected to utilize International Medical Device Regulators Forum (IMDRF) coding, which most manufacturers are not set up for.
Manufacturers are also expected to gather feedback, which is different from complaints. This also includes positive feedback about the device and information that’s not directly related to device performance, such as shipping, pricing, and so on.
You should also include publicly available information about similar devices in your PSUR/PMS report. Notified bodies expect you to monitor information that’s available from public databases beyond just the EU about similar devices, including, but not limited to, public adverse events and FSCA databases. The intent behind collecting data related to similar devices is to give manufacturers the ability to anticipate what could happen with their own devices by monitoring what is happening with similar devices on the market.
Literature searches are another commonly used method manufacturers use to look for data on similar devices in public literature and registries. These searches are mostly looking for adverse events, off-label use, and misuse of products to inform potential design changes.
Summary of Proactive Data Collection Results
During post-market clinical follow-up (PCMF) activities, manufacturers actively collect data on the safety and performance of the device once marketed. PMCF data can be collected through surveys, registries, and clinical investigations, then presented in the PSUR or PMS report.
For a specific example, if a “scientifically valid” user feedback survey is undertaken as a means of proactive data collection (because manufacturers are not just waiting for customers or users to report on their experiences), then a summary of the data from the survey should then be presented in the PSUR. In general, implementing PMCF activities requires additional time, resources, and processes and is driven by collaboration between clinical, medical safety, regulatory, quality, customer service, and marketing teams, so cross-functional coordination is key.
→ PSURs and PMS reports are just one piece of the puzzle when it comes to MDR/IVDR compliance. Watch our on-demand webinar, "Overcoming Your Challenges and Streamlining the SSP and SSCP" to learn about writing compliant SSPs and SSCPs.
Common PSUR/PMS Report Challenges
Because post-market reporting is still relatively new under MDR/IVDR and there is no official guidance yet, many manufacturers are facing challenges with producing compliant PSURs and PMS reports.
No Processes in Place
Most manufacturers have systems and processes for handling complaints but nothing in place for gathering other types of feedback or proactive post-market surveillance activities. Manufacturers need to allocate resources for this work, and it must be an ongoing effort to gather information throughout the course of the year, not in the few months before the PSUR/PMS report is due. Preparing the PSUR/PMS report should be a matter of collating and analyzing the data that already exists, not a last-minute scramble to source data.
When complaints come in, they should be assigned a series of codes related to what the customer reported and what the manufacturer finds during the course of an investigation. It’s critical to get the coding right because it informs next steps and impacts data and trends. Preferably, the codes should conform to IMDRF standards, which are:
- Medical Device Problem
- Cause Investigation - Type of Investigation
- Cause Investigation - Investigation Findings
- Cause Investigation – Investigation Conclusion
- Health Effects - Clinical Signs and Symptoms or Conditions
- Health Effects - Health Impact
- Medical Device Component
These codes help manufacturers more easily classify and analyze what problems are being reported, how the problem was evaluated, and what the root cause of the problem is. Implementing or changing codes is a significant undertaking for manufacturers, so it’s important to get it right the first time.
Notified bodies expect device manufacturers to perform regular trending analysis of reactive data. The analysis should cover a specific period of time. In the case of PSURs, it’s one year, but it could be longer for a PMS report. For the first year, the challenge will be setting up the processes and templates to gather, analyze, and present this information. In future years, notified bodies want to see trend comparisons to previous years, so account for this in the processes you are setting up now.
Trending analysis must be statistically valid with limits and thresholds, so make sure qualified professionals are doing this work. The limits and thresholds are used to identify whether an event trips a trigger that indicates action needs to be taken. When presenting trending data, identify the issues or incidents that triggered action because they exceeded the thresholds in place.
Additionally, even though the trending period is one year, the reporting period should cover multiple years—at RQM+, we’ve seen four or five years be most successful. Then the trending period will need to be compared to a baseline. The baseline period should not have any spikes (data trends) in and of itself. Finding appropriate baseline periods is a good first start when writing the initial PSUR.
In addition to trending data, manufacturers should have thresholds in place to trigger action. Most manufacturers don’t have formal statistical trending in place or formal thresholds or triggers that inform action. If you don’t start doing this now, it could snowball and lead to:
- Requests for more detailed trending methodologies, such as tailored to device type and risk classification during notified body review
- Not performing appropriate vigilance actions when a complaint trend-triggering action is missed
There are a few things to keep in mind for trending to be compliant:
- Complaint codes must be trended individually. A best practice is to set a minimum threshold based on the risk matrix in the risk management file to avoid trending every complaint code, even if it only had a few complaints reported in a given period.
- Trending must occur more frequently than the PSUR. Ideally, trending should be performed at least quarterly and aligned with complaint review boards. This will ensure that vigilance reports can be submitted in a timely manner when necessary.
- Establish a way to report on prior trends and resolution in PSUR renewals. This can serve as a check to ensure the PMS system is effective. When presenting trending data, identify the issues or incidents that triggered action because they exceeded the thresholds in place.
Top Tips for Manufacturers Preparing PSURs/PMS Reports
Preparing for PSURs and PMS reports should not be a last-minute activity right before the deadline. Writing the report should be a matter of presenting existing data and the analyses that have already been performed.
Getting Proactive Processes in Place
Ideally, this is already done or in progress, but manufacturers must implement new processes and systems to proactively gather data. Not including this type of data is not an option—notified bodies expect to see it.
Building Your Bench
For proactive data collection, get marketing and customer service teams involved in gathering information from customers. This could include periodic surveys or interviews that gather feedback from patients and/or physicians. For trending analysis, ensure you have qualified resources to perform statistically valid trending. This is relatively new for many manufacturers, so it might require adding resources to the team.
You can also outsource as appropriate to an MDR/IVDR consultant to support your team by writing PSURs and PMS reports, providing guidance on strategy, or boosting the capabilities of your complaint-handling team.
How RQM+ Helps
Former notified body leaders at RQM+ have a deep understanding of what reviewers expect to see. We provide a range of PSUR services, including:
- An integrated approach to ensure PSURs align with other tech docs, such as CERs and PMCF reports
- Establishing PMS process, SOPs, tools, and PMS report/PSUR templates
- Assisting with PSUR data collection
- In-depth complaint data analysis and trending
- PMS report and PSUR writing
Whether you need help with strategy, implementation, or everything in between, our team is here to provide guidance and supplement your internal resources.
PSURs and PMS reports are just one piece of the puzzle when it comes to MDR/IVDR compliance. Watch our on-demand webinar, "Overcoming Your Challenges and Streamlining the SSP and SSCP," to learn more about writing compliant SSPs and SSCPs.