Post-Market Surveillance 2.0: Meeting Global Regulatory Demands

The regulatory environment for medical devices has undergone a seismic shift in the last five years. One of the most profound changes is the new expectation that manufacturers must proactively and systematically monitor their devices once they reach the market. Gone are the days when post-market surveillance (PMS) simply meant collecting complaints and responding to adverse event reports. Today, regulators in the United States, Europe, and globally expect manufacturers to operate a comprehensive PMS system that continuously generates, analyzes, and feeds back safety and performance data into the quality management system.

This approach, sometimes called “PMS 2.0,” aligns with the broader push for lifecycle regulation. It recognizes that medical devices evolve in the field, patient populations change, and risks can emerge long after launch. Regulators now require firms to proactively manage those risks, not just react when things go wrong.

In this blog we will examine what PMS 2.0 means in practice, what regulations require, the common pitfalls companies face, and the strategic benefits that can result from investing in robust PMS systems.

Regulatory Framework

Europe (MDR and IVDR)

The EU MDR and IVDR set the global benchmark for PMS requirements. Key obligations include:

• PMS Plans: Every device must have a documented PMS plan describing how data will be collected, analyzed, and reported.

  
  

• PSURs and PMS Reports:

  
  

  • Class I devices: PMS reports updated as needed.

  • Class IIa and above: Periodic Safety Update Reports (PSURs) at least every two years (Class IIa) or annually (Class IIb and III).

  • IVDR Class C and D: PSURs are required.

    
    

• Post-Market Clinical Follow-Up (PMCF) and Post-Market Performance Follow-Up (PMPF): Continuous collection of clinical or performance data to confirm safety and performance claims.

  
  

• Trend Reporting: Companies must monitor and report any statistically significant increase in non-serious incidents or expected adverse events.

  
  

Notified Bodies now routinely focus on PMS during audits. Weak or generic PMS plans are one of the most common nonconformities.

United States (FDA)

The FDA’s quality system regulation already required complaint handling and Medical Device Reporting (MDR). However, recent enforcement trends show FDA placing greater emphasis on proactive PMS. Warning letters often cite failures in complaint trending, CAPA integration, and real-time monitoring. With the upcoming QMSR alignment to ISO 13485, FDA will explicitly expect ISO-style PMS systems that mirror MDR requirements.

United Kingdom and Other Markets

The UK implemented enhanced PMS requirements in June 2025, closely aligned with EU MDR standards. Countries such as Canada, Australia, and Brazil, many participating in MDSAP, also align with ISO 13485’s PMS clauses. In effect, PMS 2.0 is now a global expectation.

Why PMS Matters

Effective PMS systems are not just regulatory requirements, they are fundamental to patient safety and brand protection. A weak PMS program risks:

• Delayed identification of device failures.

• Larger recalls due to missed early signals.

• Notified Body findings, loss of CE marking, or FDA warning letters.

• Litigation and reputational harm.

  
  

Conversely, strong PMS systems offer significant benefits:

• Early detection of emerging risks.

• Data-driven design improvements.

• Market differentiation through proven real-world performance.

• Stronger trust with regulators and customers.

  
  

Practical Implementation Steps

1. Create Device-Specific PMS Plans: Avoid generic templates. Each PMS plan should describe exactly how data will be collected for that device, what data sources will be used, and how often analysis will occur.

   
   

2. Integrate PMS with Risk Management: ISO 14971 requires risk management throughout the device lifecycle. PMS data must feed back into the risk file, with risk assessments updated as new information emerges.

   
   

3. Develop Robust PMCF and PMPF Programs: For higher risk devices, passive surveillance is not enough. Consider post-market studies, registries, user surveys, or literature reviews to generate new evidence.

   
   

4. Automate Data Collection Where Possible: Leverage complaint databases, service records, and even real-world data from connected devices. Automated trending tools can detect issues earlier than manual reviews.

   
   

5. Prepare PSURs Carefully: Regulators expect PSURs to be detailed, with clear analysis of benefits versus risks and conclusions supported by data. These are not check-the-box documents.

   
   

6. Coordinate with Clinical, Regulatory, and Quality Teams: PMS requires cross-functional input. Clinical teams provide expertise in study design, QA ensures process integrity, and RA ensures reports meet regulatory expectations.

   
   

Common Pitfalls and Case Examples

• Generic PMS Plans: A company submitting identical PMS plans for multiple devices was cited by its Notified Body. The NB concluded the plans did not reflect the specific risks of each device.

  
  

• Failure to Trend Data: FDA issued a warning letter to a firm that collected complaints but did not statistically analyze them. Investigators noted that earlier trending could have identified a recurring issue before it caused harm.

  
  

• Delayed PMCF: An orthopedic implant company failed to initiate a PMCF study as committed in its CER. The Notified Body suspended its CE certificate until the study was underway.

  
  

Strategic Implications for Leadership

For executives, PMS is not just a compliance function. It is a strategic tool that can strengthen market position. CEOs should ask:

• Do we know how our devices are performing in real-world use?

• Are we using PMS data to drive continuous improvement?

• Are our PMS systems scalable across global markets?

  
  

For QA/RA leaders, PMS is now one of the most scrutinized areas in audits and inspections. It must be resourced accordingly.

For product and R&D leaders, PMS provides insights that can guide future design improvements and innovation.

Final Thoughts

Post-market surveillance has evolved into a proactive, data-driven, and globally harmonized requirement. Companies that treat PMS as strategic, not just regulatory, will not only avoid compliance pitfalls but also deliver safer, better-performing products.

How PRP Compliance Can Help: We support clients in building PMS systems, producing PSURs, and designing PMCF and PMPF studies that satisfy regulators while providing strategic insights. Contact PRP Compliance to strengthen your PMS program and protect both patients and your business.