Post-Market Surveillance (PMS) Services for Medical Devices (EU MDR Compliance)
Our Post-Market Surveillance (PMS) services support medical device manufacturers in maintaining ongoing compliance with EU MDR requirements. Patient Guard provides expert guidance to ensure your PMS system effectively monitors device safety, performance, and regulatory compliance throughout the product lifecycle.
Post-Market Surveillance (PMS) Services
Post-Market Surveillance (PMS) is a mandatory requirement under EU MDR (EU 2017/745) and forms a critical part of the medical device lifecycle.
Manufacturers must establish, implement, and maintain a PMS system to proactively collect and analyse post-market data related to device safety, performance, and usability.
A compliant PMS system supports ongoing Clinical Evaluation, Risk Management, and vigilance activities while demonstrating continued benefit-risk acceptability.
Patient Guard acts as your regulatory consultancy partner, supporting the development, implementation, and maintenance of compliant PMS documentation aligned with EU MDR and MDCG guidance.
Without an effective PMS system, manufacturers risk Notified Body non-conformities, regulatory delays, and potential market restrictions.
Patient Guard provides expert PMS services tailored to your device classification, intended use, and regulatory obligations, ensuring compliance and audit readiness.
Why Choose Patient Guard for Medical Device PMS?
Proactive Data Systems
We build PMS frameworks that move beyond reactive complaint handling. We design proactive data-gathering strategies that spot safety trends and satisfy strict regulatory expectations.
MDR, IVDR & MHRA Expertise
We deeply understand the shifting timelines and reporting rules across the UK and Europe, keeping your PMS plans completely aligned with Notified Body and MHRA standards.
End-to-End File Continuity
Our regulatory team seamlessly links your post-market data back into your ISO 14971 Risk Files and Clinical Evaluations (CER/PER), closing the loop required for compliance.
What Our PMS Service Includes
PMS Plans & Reports
We generate compliant Post-Market Surveillance Plans alongside final Post-Market Surveillance Reports (PMSR) customized cleanly to your product's classification group.
PSUR Generation
For higher-risk devices, we author and update comprehensive Periodic Safety Update Reports (PSUR) outlining risk-benefit ratios to ensure seamless submission readies.
Vigilance & Incident Reporting
We guide you through time-sensitive adverse event monitoring, trend analysis, and direct regulatory notification pathways to handle incident reporting with confidence.
PMCF & PMPF Integration
We map out robust Post-Market Clinical Follow-up (PMCF) or Performance Follow-up (PMPF) methods to actively collect ongoing clinical performance data.
Audit Preparation & Support
We evaluate your legacy post-market files against modern standards, leading robust mock gap assessments to keep your data ready for Notified Body reviews.
Who Requires PMS?
- Medical device manufacturers under EU MDR
- Companies seeking CE marking
- Class I, IIa, IIb, and III device manufacturers
- Organisations undergoing Notified Body review
- Companies requiring PSUR or PMS documentation updates
EU MDR PMS Requirements
Under EU MDR, manufacturers must:
- Establish and maintain a PMS system
- Develop a PMS Plan
- Collect and analyse post-market data
- Prepare PMS Reports or PSURs
- Implement corrective and preventive actions where necessary
- Integrate findings into risk management and clinical evaluation
A compliant PMS system is essential for demonstrating ongoing device safety and regulatory compliance.
Our Process
Step 1 – PMS Strategy & Planning
We assess your device classification, intended use, and regulatory obligations to develop a compliant PMS strategy
Step 2 – Data Collection & Analysis
We establish post-market data collection methods and evaluate complaints, feedback, vigilance, and trend data
Step 3 – PMS Reporting & Compliance
We prepare PMS Reports or PSURs and align outputs with CER, PMCF, and risk management documentation
Industries We Support
We support PMS services across:
- Medical device manufacturers
- Implantable device companies
- Digital health and SaMD
- Start-ups and global manufacturers
Cost of Service
Post Market Surveillance Services
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Ensure regulatory compliance and market readiness with expertly prepared PMS Plans, PMS Reports and PSURs.
Features
- PMS Plan development aligned with EU MDR Article 84 and Annex III requirements
- PMS Report and PSUR preparation for ongoing regulatory compliance and Notified Body review
- Complaint, vigilance, and trend analysis to support proactive post-market monitoring
- Integration of PMS outputs with Clinical Evaluation, PMCF, and Risk Management documentation
Time Lines
Weeks 1–2 – PMS Strategy & Planning
Assess device classification, intended use, and regulatory obligations to develop a compliant PMS Plan
Weeks 3–6 – Data Collection & Analysis
Establish PMS processes and analyse complaints, vigilance, trend data, and post-market feedback
Weeks 7–10 – PMS Reporting & Compliance
Prepare PMS Reports or PSURs and align outputs with CER, PMCF, and risk management documentation
Frequently Asked Questions (FAQs)
What is Post-Market Surveillance (PMS)?
PMS is the process of proactively collecting and analysing post-market data to ensure continued device safety and performance.
Is PMS mandatory under EU MDR?
Yes, PMS is a mandatory requirement for all medical devices under EU MDR.
What is the difference between a PMS Report and a PSUR?
A PMS Report is generally required for Class I devices, while a PSUR is required for Class IIa, IIb, and III devices.
How often should PMS documentation be updated?
Updates depend on device classification and regulatory requirements, but PMS activities must remain ongoing throughout the product lifecycle.
How does PMS relate to PMCF and CER?
PMS data supports ongoing Clinical Evaluation, PMCF activities, and Risk Management updates.
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