PMS

Post-Market Surveillance (PMS) is a mandatory regulatory requirement under EU MDR Articles 83-86 that requires manufacturers to establish and maintain a systematic, proactive process for collecting, recording, and analyzing data about the quality, performance, and safety of medical devices throughout their lifecycle after market placement.

EU MDR requirements:
Under the EU Medical Device Regulation (EU) 2017/745, every manufacturer must:
- Establish a post-market surveillance system appropriate to the risk class and device type
- Develop and maintain a documented PMS plan
- Generate periodic PMS reports (or Periodic Safety Update Reports for higher-risk devices)
- Actively collect and analyze data from multiple sources

PMS plan requirements:
The PMS plan must include:
1. General information - Device identification, classification, risk class
2. Data collection methods - Sources and procedures for gathering data
3. Data analysis methods - Statistical techniques and trend analysis approaches
4. Objectives - Specific safety and performance metrics to monitor
5. Timelines - Frequency of data collection, analysis, and reporting
6. Responsibilities - Roles and responsibilities for PMS activities
7. Vigilance link - Connection to complaint handling and vigilance reporting

Data sources for PMS:
Manufacturers must collect information from:
- Customer feedback - Complaints, returns, service reports
- Clinical data - Post-market clinical follow-up (PMCF) studies
- Literature - Scientific publications and clinical evidence
- Market data - Sales volumes, installation base, usage patterns
- Competent authority reports - Safety communications, field safety notices
- Similar devices - Incidents and safety data from comparable products
- Social media and forums - User experiences and discussions

PMS report requirements:
The PMS report must summarize:
- Data collected during the reporting period
- Evaluation of data and trend analysis
- Number and types of incidents
- Risk-benefit analysis updates
- Volume of sales and estimated population exposed
- Summary of corrective actions taken
- Conclusions and proposed preventive actions

Reporting frequency by risk class:
- Class I - Part of technical documentation, updated as needed
- Class IIa - PMS report updated when technical documentation updated
- Class IIb - PMS report at least every 2 years
- Class III/Implantable - Periodic Safety Update Report (PSUR) annually

Relationship to other post-market activities:
PMS is closely integrated with:
- Vigilance - Mandatory reporting of serious incidents and field safety corrective actions
- PMCF - Clinical follow-up studies to gather clinical safety and performance data
- Trend reporting - Identification of statistically significant increases in incidents
- Risk management - Ongoing evaluation and update of risk analysis

PMS vs PMCF:
| Aspect | PMS | PMCF |
|--------|-----|------|
| Scope | All quality, safety, performance data | Clinical data specifically |
| Methods | Complaints, literature, market data | Clinical studies, registries, surveys |
| Requirement | All devices | Focus on higher-risk devices |
| Output | PMS report or PSUR | PMCF evaluation report |

Compliance considerations:
- PMS is a proactive requirement, not reactive - manufacturers cannot wait for problems
- Insufficient PMS is a leading cause of notified body audit findings
- PMS must be tailored to device risk and specific safety concerns
- Data must be analyzed, not just collected
- PMS plan must be reviewed and updated regularly

PMS is a cornerstone of the EU MDR's lifecycle approach to medical device safety, ensuring that real-world experience continuously informs the risk-benefit evaluation of marketed devices.