7 Common Post-Market Surveillance Mistakes MedTech Manufacturers Makeā€”and How to Correct Them
Avoid These PMS Pitfalls to Strengthen EU MDR Compliance
Yu Jin, Global Clinical and Regulatory Affairs Manager, (Notified Body 1639), SGS Belgium
The EU MDR & IVDR Insider editorial team asked Yu Jin, Global Clinical and Regulatory Affairs Manager at SGS Belgium (Notified Body 1639), to share common pitfalls she sees in post-market surveillance submissions.
[Download a Practical Guide to Device & IVD Post-Market Surveillance, Vigilance & Reporting]
Drawing on her extensive experience reviewing technical documentation under MDR, Yu outlined seven recurring mistakes—and what manufacturers can do to correct them.
1. Generic PMS procedures that ignore device-specific risks
Many manufacturers still treat post-market surveillance as a documentation exercise. They often submit the same PMS template across product lines without adapting to the unique risks or clinical context of each device.
According to Yu, this falls short of what the MDR requires.
“A generic PMS procedure is submitted as part of the Technical Documentation,” she said. “The manufacturer did not create a device-specific PMS plan (including PMCF plan) taking into account risks and characteristics of the device.”
Without tailoring PMS activities to the device, manufacturers miss important real-world signals that standardized plans can’t capture.
2. No PMCF plan—even when one is expected
Manufacturers sometimes assume that lower-risk devices don’t require any post-market clinical follow-up.
That assumption leads to critical evidence gaps.
Yu sees this mistake often, especially when manufacturers leave out even the most basic follow-up activities.
“NO PMCF plan at all,” she noted, “including general PMCF activities. For lower-risk devices, the manufacturer fails to provide a PMCF plan. While it is acceptable not to perform PMCF studies, general PMCF activities such as literature search and gathering feedback are normally expected.”’
Even without a clinical study, regulators expect to see a proactive plan to gather real-world insights.
3. PMS findings don’t feed into risk management or CERs
One of the most overlooked problems in PMS is the lack of integration. Risk files and clinical evaluation reports are rarely updated based on post-market data.
“Insufficient update of risk management and CER based on PMS,” Yu explained. “Manufacturers did not integrate PMS data effectively into their risk management processes, did not incorporate new information gained during the post-market phase into CER and IFU.”
When PMS outputs aren’t used to revise other documentation, it signals a disconnect between surveillance and quality systems.
4. PMCF plans that ignore general activities
Some PMCF plans focus narrowly on formal studies or registry data but skip essential general activities like literature reviews and user feedback.
When PMS outputs aren’t used to revise other documentation, it signals a disconnect between surveillance and quality systems.
“PMCF plan only covers ‘specific PMCF activities,’” she said, “and did not include general PMCF activities, such as search of literature database, or gather feedback from users.”
These broader efforts are not optional—they help validate performance across diverse populations and real-world contexts, especially when formal studies aren’t feasible.
5. PMCF plans with no operational details
It’s not enough to list an activity. Regulators want to see how the plan will be carried out: who’s collecting the data, from where, and on what timeline.
Yu said vague PMCF plans are a common problem.
“A PMCF survey is listed as part of the PMCF plan,” she said, “however, no details are provided—such as questions to be collected, sites, estimated patient numbers, timelines for data collection and reporting.”
A checklist of intentions isn’t enough. Implementation details are needed to show that the plan is real, actionable, and meaningful.
6. PSURs that overwhelm—or underdeliver
The Periodic Safety Update Report (PSUR) is intended to provide a clear, high-level view of the device’s benefit-risk profile over time. However, according to Yu, many manufacturers include either too little or far too much.
Some reports list every incident or PMCF result without synthesis, while others skip entire years of data. Both approaches make it hard for reviewers to assess ongoing safety or performance. Yu emphasized that manufacturers should summarize, interpret, and present only the most relevant data in a clear structure.
7. PMS follow-up after a field action isn’t specific enough
Post-market surveillance must adapt after a field safety corrective action (FSCA). Yu emphasized that PMS plans should reflect the specific cause of the issue and how it’s being tracked.
“It depends on what is the root cause and what are the corrective actions taken,” she said. “For example, if the issue is related to usability, the manufacturer may proactively gather user feedback during PMS. If the FSCA is due to packaging or sterilisation, such aspects shall be closely monitored during the PMS, and will be reviewed during QMS auditing.”
Generic PMS is a red flag after a recall. Regulators expect to see a feedback loop that directly monitors the affected area.
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Yu Jin is a medical doctor specializing in cardiology with eight years of academic research and postdoctoral training in cardiovascular epidemiology, clinical trials, and medical statistics. She brings over a decade of experience in the medical device industry and currently serves as a clinical manager at SGS Belgium, overseeing the clinical assessment process for EU MDR submissions. With deep expertise in clinical evaluation and investigation under MDR, Yu Jin has authored 12 first-author and 39 co-authored publications and is known for her clear, evidence-based approach to regulatory review.
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