11. Ignoring Post-Market Surveillance (PMS)? Here’s How It Can Destroy Your MedTech Business

Introduction: Why PMS Matters

Post-market surveillance (PMS) is your systematic means of monitoring the safety and performance of your medical device in real-world use post-market launch.

Why it matters:

✅ Devices don’t work the same in the real world: Variations between patient cohorts, user settings, misuse, or unforeseen circumstances may lead to malfunctions or adverse effects.

✅ Finds long-term or rare risks: Some issues only arise after several years of usage or under circumstances not simulated by pre-market testing.

✅ Facilitating continual improvement: PMS data can lead to design, labeling, or process modifications, improving product quality and competitiveness.

✅ Regulation requirement: FDA, EU MDR, and foreign export markets require producers to report post-market surveillance regularly to confirm public health.

✅ Legal and financial protection: Early indications of issues avert costly recalls, legal suits, or loss of reputation.

Without proper PMS:

❌ You tend to miss early indicators of trouble, and failures will be in significant numbers.

❌ Regulators issue warning letters or recalls.

❌ Distributors and hospitals lose faith in your firm.

❌ Patients face unnecessary harm.

???? Regulatory Framework: FDA vs. EU MDR

United States (FDA)

FDA’s approach towards PMS is:

✅ Medical Device Reporting (MDR, 21 CFR Part 803): Requires device manufacturers to report deaths caused by devices, serious injury caused by devices, and specific malfunctions within certain periods.

✅ Quality System Regulation (21 CFR Part 820): Efficient handling of complaints, CAPA, and internal feedback processes is crucial to monitor post-market complaints in a systemized fashion.

✅ 522 Postmarket Surveillance Studies: The FDA can require necessary additional post-market data collection for specific devices with known or suspected risk.

✅ Post-Approval Studies (PAS): For safety and performance surveillance post-approval.

Important note: Even though the FDA doesn’t officially employ “PMS,” its infrastructure necessitates systematic post-market data collection, analysis, and action.

European Union (EU MDR)

EU MDR Articles 83–86 specifically mandate PMS:

✅ A PMS Plan (Annex III): Specifies your data collection, analysis, and action process.

✅ PMS Reports (Class I devices): Occasional reports of the PMS results and corrective actions.

✅ PSUR (Periodic Safety Update Report) for Class IIa, IIb, III: Needs:

Summary of PMS results.

Update benefit-risk assessments.

Sales/usage data and remedial actions.

In addition:

✅ PMS results should help:

Clinical Evaluation Reports (CERs).

Risk management updates (as per ISO 14971).

Labeling and Instructions for Use (IFU) updates.

???? PMS Objectives

1️⃣ Confirm Safety and Performance under Real-Life Use

Devices may act differently in the real world outside of controlled clinical trials due to:

✅ User variability (clinicians, patients, caregivers).

✅ Environmental conditions (temperature, humidity, handling).

✅ Comorbidities in patients not found in pre-market studies.

PMS guarantees your device remains safe and functions as intended under these conditions.

2️⃣ Locate New or Unanticipated Risks

No pre-market testing can be conducted for every situation; PMS finds:

✅ Rare adverse events.

✅ Misuse patterns leading to safety issues.

✅ Unanticipated device interaction with other devices.

Example: A wearable device inducing skin irritation because of hot weather revealed by PMS reports.

3️⃣ Monitor Known Hazards

PMS guarantees:

✅ Stability of frequency and magnitude of known hazards with your hazard analyses.

✅ When trends change (e.g., growing complaints concerning a specific failure mode), repairs are done.

4️⃣ Find Improvement Opportunities

Data from PMS reveals:

✅ Usability defects that require design changes.

✅ Label improvements to be more understandable.

✅ Firmware/software patches to enhance reliability.

5️⃣ Regulatory Compliance and Market Availability

✅ The FDA and EU MDR require systematic post-market monitoring.

???? Hospitals notified bodies and distributors that they need evidence of continuous monitoring to stay associated.

Step-by-Step Guide: Creating Your PMS System

1️⃣ Create a PMS Plan

What is it?

A written report showing you how you will collect, analyze, and act on post-market data for your device with ongoing monitoring.

Key Elements:

The device provides information about its description, intended use, and risk class.

Sources of data:

Complaints and MDR/vigilance reports.

PMCF data, clinical studies, and registry data.

Literature and competitor recalls.

User feedback and field input.

✅ For:

Data collection (who, how, where data are taken).

Data analysis and trend tracking.

Action trigger threshold definition (CAPAs, design changes, regulatory notices).

✅ Roles and responsibilities:

Who is accountable for PMS in your company?

Who collects and analyzes data, triggers action, and reports outcomes?

✅ PMS Report and PSUR development timelines.

Practical Guidance:

Create your PMS plan alongside your design effort to be launch-ready.

Please put it in your QMS under document control so it is easy to update.

2️⃣ Develop Data Collection Procedures

Why:

Systematic collection enables you to capture relevant data at regular intervals, not just when issues are severe.

Data Sources:

✅ Customer complaints and product returns.

✅ Adverse event reports from the user or distributor.

✅ Service and maintenance records (masked failures found during servicing).

✅ PMCF surveys and follow-up data.

✅ Public databases (FDA MAUDE, EUDAMED).

✅ Search the literature for emerging threats with similar devices.

Implementation Tips

✅ Use CRM/eQMS integrated intake forms for complaints and service reports.

✅ Train support and service staff to spot and refer potential safety indicators.

✅ Document each data point with the date, device identifiers, and information.

3️⃣ Act Proactively on Data

Why:

You need to see patterns, trends, and outliers beforehand, not simply react to single complaints.

How

✅ Trend analysis: Track complaint and adverse event rates over time.

✅ Stratify by:

Lot/batch numbers.

Geography/market.

Determine the type of user, whether it’s a clinician or a patient.

✅ Use control charts and dashboards to signal spikes.

✅ Cross-reference against your risk management file for acceptability thresholds for risks.

Example:

Trend analysis detects a spike in Bluetooth disconnects in one of your firmware releases, prompting investigation and corrective action.

4️⃣ Integrate PMS Findings with Risk Management and CAPA

✅ Update your ISO 14971 risk management document when:

New risks are identified.

Increase the frequency orseverity of a known risk.

Existing controls are not sufficient.

✅ Leave CAPAs open for:

System-wide issues that must be investigated and corrected.

Changes in process or design are necessary due to recurring problems.

✅ Keep applicable results into:

Update the Instructions for Use (IFU) and labeling to include additional precautions.

Updates for user training are also necessary.

5️⃣ Comply with Regulatory Reporting Requirements

FDA Requirements:

✅ File MDRs:

The 30-day period applies to deaths, severe injuries, and malfunctions.

5-day report for specific critical issues.

✅ Report data under a 522 Order by FDA schedules.

✅ Report PAS updates for PMA devices as required.

EU MDR Requirements

✅ PMS Report (Class I devices): Reports on PMS activities and conclusions.

✅ PSUR (Class IIa, IIb, III devices):

The Class IIb/III devices require an annual submission.

Biennial for Class IIa.

Include the benefit-risk analysis and sales/usage data.

✅ Ensure that it is included in your Clinical Evaluation Report (CER) and risk documentation.

6️⃣ Management Review and Oversight

Track PMS outcomes in your QMS management reviews to:

✅ Update senior management with trends and concerns.

✅ Facilitate resource allocation for action needed.

✅ Verify the performance of your PMS processes.

Auditing will require documentation of the reviews conducted.

7️⃣ Update Technical Documentation and Processes

Within the context of PMS outcomes:

✅ Review your record of risk management with additional information.

✅ Update Clinical Evaluation Reports (EU MDR) if new evidence affects benefit-risk assessment.

✅ Correct IFUs or labeling if additional warning or explanation is necessary.

✅ Record revisions to show noticeable improvement over time.

⚠️ Do Not Make the Following Mistakes

❌ Constraining PMS to a reactive complaint-only function.

❌ Failing to analyze cumulative data, losing trend identification.

❌ Late MDR or vigilance reporting.

❌ Failure to update risk management or design files after PMS results.

❌ Inadequate documentation and record keeping.

❌ Treating PMS as a checkbox exercise rather than an improvement tool for quality.

Tips on How to Have a Good PMS System

✅ Actively plan your PMS system before launch.

✅ Employ formalized electronic trend monitoring and data collection systems.

✅ Set forth clear-cut escalation thresholds.

✅ Train your teams to notice and report PMS data.

✅ Seamless integration of PMS in CAPA and risk management.

✅ Continuous record of analysis, decision, and action taken.

✅ Review PMS effectiveness during management reviews.

✅ Use PMS data for continuous product improvement.

Real-World Example

Situation: A Class II wearable product company experienced a slight but steady increase in skin irritation complaints under PMS monitoring.

✔ Led this trend by complaint statistics categorized by geography and climate.

✔ Root cause analysis showed adhesive defects caused and exacerbated by humidity and perspiration.

✔ Company:

I opened a CAPA for an official investigation.

Resimplified the adhesive.

Added skin preparation words to the IFU.

I have trained the support staff to handle complaints effectively.

Results

There was an 80% decrease in related complaints within 3 months.

This has led to an increase in customer and distributor confidence.

Improved preparation for QMS audits is also observed.

Benefits of having a good PMS System

✅ Maintains patient safety and prevents harm.

✅ Builds a high-quality, inspection-capable QMS.

✅ Enables proactive process and design improvements.

✅ Reduces regulatory risk and recalls.

✅ Builds regulator, distributor, and hospital relationships.

✅ Improves product performance and market confidence.

📚 References

✅ 1️⃣ FDA Postmarket Requirements
https://www.fda.gov/medical-devices/postmarket-requirements-devices

✅ 2️⃣ 21 CFR Part 803 – Medical Device Reporting
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

✅ 3️⃣ 21 CFR Part 820 – Quality System Regulation (QSR)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

✅ 4️⃣ EU MDR – Official Text (PMS Articles 83–86)
EU MDR Articles can be accessed via the European Commission’s official EUR-Lex:
https://eur-lex.europa.eu/eli/reg/2017/745/oj

Alternatively, Article-specific text for PMS:

✅ 5️⃣ ISO 13485:2016 – Medical devices – QMS Requirements
ISO standards are protected by copyright and require purchase. For official access: