Post-Market Surveillance: From Compliance to Innovation

Introduction

“PMS is not just about keeping regulators satisfied — it is about creating lasting value.”

Post-Market Surveillance (PMS) is often seen by medical device manufacturers as a regulatory burden. Under the EU MDR, PMS is designed to ensure that devices continue to perform safely and effectively once on the market.

For companies willing to look beyond checkbox compliance, PMS can become a powerful source of insight. When implemented properly, it fuels product improvement, supports market access, and turns regulatory obligations into a lever for innovation and trust.

1. PMS under EU MDR: Scope and Deliverables

The EU MDR (Articles 83–86) sets clear expectations for PMS.
Every manufacturer must establish a PMS plan and maintain it throughout the device lifecycle.

Depending on device class, this results in:

• A PMS report for Class I devices.
• A Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices.

The PSUR (see MDCG 2022-21) must be updated:

• at least every 2 years for Class IIa devices;
• annually for Class IIb and Class III devices.

To confirm ongoing safety and performance and generate actionable evidence, each PSUR should include:

• Results of the benefit–risk assessment;
• Key findings from the Clinical Evaluation Report (CER), updated with new post-market data;
• Total sales volume, as a proxy for real-world exposure;
• Estimated number of individuals exposed;
• Estimated frequency of use.

Manufacturers must also demonstrate how PMS feeds into Post-Market Clinical Follow-up (PMCF).
Together, PMS, PSUR, and PMCF form a feedback loop between real-world use, compliance, and continuous product development.

2. Effectively Collecting PMS Data

A PMS system is only as strong as the data it captures.

Under MDR, manufacturers are expected to gather information from multiple sources:

• Internal sources: complaints, incident reports, service and maintenance records, feedback from healthcare professionals.
• External sources: scientific literature, clinical registries, competitor benchmarks, authority databases (e.g. vigilance systems).
• For e-health, SaMD, and AI-based systems: real-world usage logs, algorithm performance drift, cybersecurity incidents.

PMS should be an active system that detects patterns early, captures new risks, and identifies opportunities.
Done well, this breadth of data collection not only satisfies regulators—it drives innovation and clinical adoption.

3. Analyzing PMS Data Beyond Compliance

The real value of PMS lies in turning data into insights for safety, performance, and market impact. Regulators expect PMS to actively feed into:

• Risk management (ISO 14971): integrating new hazards, incident trends, and changes in severity.
• Corrective and Preventive Actions (CAPA): triggering structured responses to recurring issues.
• Trend analysis: using statistical methods to detect subtle signals (failure rates, usability issues, regional variations).
• Clinical evaluation updates: feeding PMS findings into the CER, especially for innovative or limited pre-market evidence devices.

For SaMD and AI-enabled devices, PMS must also:

• assess usability and interpretability of outputs by clinicians;
• support explainability and safe decision-making, in line with emerging AI Act expectations.

By embracing this analytical approach, manufacturers can transform PMS into a strategic asset, lowering regulatory risk while reinforcing confidence among clinicians, patients, payers, and regulators.

4. PMS as a Lever for Innovation and Marketing

Beyond safety, PMS can be a competitive differentiator.

4.1 Fueling Product Innovation

• PMCF studies often reveal opportunities for new features, expanded indications, or workflow optimisation.
• For SaMD and AI-based devices, PMS highlights algorithm drift and evolving clinical needs, helping to prioritize updates.

4.2 Differentiation in the Market

• Transparent communication on safety and performance demonstrates commitment to patient protection.
• Real-world evidence from PMS strengthens reimbursement submissions, HTA dossiers, and marketing claims.
• Robust PMS practices reassure skeptical clinicians and support adoption of innovative technologies.

4.3 Building Trust with Stakeholders

• Proactively sharing PMS insights positions manufacturers as trusted partners.
• Aggregated, anonymized data (usage trends, safety improvements) provides strong content for conferences and publications.

PMS is not just about proving a device is safe enough to remain on the market; it can be a driver of innovation, differentiation, and trust.

5. EU vs US: Different Approaches to PMS

PMS is universal, but regulatory expectations differ between the EU and the US.

5.1 European Union

• PMS is proactive and continuous.
• Every device must have a PMS plan covering its entire lifecycle.
• The framework expects not only vigilance reporting but also systematic trend analysis, and integration with risk management, clinical evaluation, and CAPA processes.

5.2 United States (FDA)

• PMS is generally more reactive.
• Manufacturers must investigate and act on complaints, but there is no equivalent requirement for PSUR or structured PMCF for all devices.
• Key mechanisms include:
  • Medical Device Reporting (MDR) via MedWatch, feeding into the MAUDE database;
  • 522 Postmarket Surveillance Studies for selected devices.

EU MDR thus demands a more comprehensive and proactive PMS system.
Once implemented, this system can serve as a solid foundation for meeting FDA expectations as well.

6. Conclusion – From Regulatory Burden to Strategic Advantage

PMS under EU MDR is far more than a bureaucratic checkbox.
When fully embraced, it becomes a continuous learning system that:

• ensures safety and compliance,
• informs product improvement,
• supports market access and marketing,
• and builds trust with clinicians, patients, and regulators.

Companies that turn PMS into an engine of innovation and transparency:

• achieve faster market access,
• earn greater confidence,
• and secure a lasting competitive edge.

Start today by reviewing your PMS plan and ensuring your PSUR and PMCF processes are:

• compliant with MDR,
• and aligned with your innovation and market strategy.

At Certeafiles, we support you at every stage:

• Personalized guidance from our experts.
• Hands-on, tailored training.
• Internal audits.

👉 Contact us for a free initial consultation and discover how Certeafiles can accelerate and secure your PMS compliance efforts.