Medical Device Post-Market Surveillance: What Manufacturers Need to Know
Getting your device on the market isn’t the finish line. Once it’s in the hands of real patients and clinicians, you need to keep watching how it performs. Real-world use shows things no pre-market test can, such as unexpected failures, misuse, and patterns that only appear at scale. Monitoring it closely lets you act early and stay on the right side of the regulators.
What Is Post-Market Surveillance?
Post-market surveillance (PMS) means collecting and reviewing information about your device after it’s available to patients and healthcare professionals. EU MDR 2017/745 requires every manufacturer to run a PMS system that covers the device’s whole lifecycle, not just its first year on the market.
What a PMS System Actually Involves
In day-to-day terms, a working PMS system comes down to five things:
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Complaint handling: Log every complaint about performance or safety, and investigate each one properly.
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Incident reporting: Report serious incidents to the competent authorities on time. Under MDR, that’s generally 15 days, 10 days for a death or unexpected serious deterioration in health, and 2 days for a serious threat to public health.
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Data collection: Don’t wait for complaints to arrive. Ask users, distributors, and clinicians for feedback.
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Trend analysis: One complaint may be noise, but ten of the same kind is a signal. Look for recurring problems and gradual drops in performance.
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Corrective action: When you find a real problem, fix it and document what you did.
Making PMS Work in Practice
Start with a clear PMS plan. It should say what data you collect, how you collect it, who owns each task, and how reports get escalated. Then review the data regularly. Customer feedback, incident reports, and new clinical evidence often show a problem early, if someone is looking.
Reports You May Need to Prepare
Good PMS protects patients, and it’s also a legal obligation. Depending on your device class, you’ll need to produce one of two documents:
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PMSR (Post-Market Surveillance Report): for Class I devices
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PSUR (Periodic Safety Update Report): for Class IIa, IIb, and III devices
Done well, PMS leads to better products, smoother audits, and more trust from the clinicians who use your device.
Need a Hand?
At MASUU Global, we help Medical device post market surveillance manufacturers with PMS documentation, regulatory consulting, and compliance support, so you can meet your post-market obligations without it taking over your team.