Post-Market Surveillance Explained: Why It’s Critical Under MDR
Compliance doesn’t end when a medical device enters the market. Under MDR, Post-Market Surveillance (PMS) has become a critical requirement to ensure devices remain safe and effective throughout their lifecycle.
What is Post-Market Surveillance (PMS)?
Post-Market Surveillance is the process of continuously monitoring medical devices after they are placed on the market. MDR requires manufacturers to collect and analyze data on product performance, adverse events, and safety concerns.
Unlike the old MDD system, PMS is no longer optional — it is a mandatory, ongoing activity.
Why PMS is Critical Under MDR
- Patient Safety Comes First Monitoring real-world use helps detect risks or defects that may not appear in clinical trials.
- Regulatory Compliance Without PMS, companies risk losing CE certification and EU market access.
- Improved Device Quality Data collected from PMS leads to design improvements and innovation.
- Transparency and Trust PMS results feed into the EUDAMED database, making information accessible to regulators, patients, and healthcare providers.
Key PMS Requirements in MDR
- PMS Plan: Every manufacturer must have a documented plan tailored to their devices.
- Periodic Safety Update Report (PSUR): Required for Class IIa, IIb, and III devices.
- Post-Market Clinical Follow-up (PMCF): Continuous collection of clinical data to support safety and performance claims.
- Vigilance System: Mandatory reporting of serious incidents or corrective actions.
Best Practices for PMS Compliance
- Create a Strong PMS Plan: Define how data will be collected and analyzed.
- Use Multiple Data Sources: Include customer feedback, complaint records, scientific literature, and market reports.
- Automate Where Possible: Digital tools help track, store, and evaluate PMS data efficiently.
- Integrate PMS with QMS: Ensure findings lead to updates in your Quality Management System.
- Train Staff: Everyone involved in product monitoring should understand their role.
Challenges in PMS Implementation
- High Cost of Data Collection
- Difficulty in Standardizing Data
- Limited Resources in Smaller Companies
Overcoming these challenges requires careful planning, investment in digital systems, and sometimes external support.
Conclusion
Post-Market Surveillance under MDR is not just a regulatory requirement — it’s a commitment to patient safety, transparency, and continuous improvement.
By treating PMS as an integral part of the device lifecycle, companies can ensure compliance, build stronger trust with healthcare providers, and maintain their competitive edge in the EU market.
