Post-Market Surveillance (PMS) Services for IVDs (IVDR Compliance)
Our Post-Market Surveillance (PMS) services support IVD manufacturers in maintaining ongoing compliance with IVDR (EU 2017/746) 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 for IVDs
Post-Market Surveillance (PMS) is a mandatory requirement under IVDR and forms a critical component of the IVD lifecycle.
Manufacturers must establish, document, implement, and maintain a PMS system to proactively collect and analyse post-market information relating to device quality, safety, and performance.
A compliant PMS system supports ongoing Performance Evaluation, Scientific Validation, PMPF activities, vigilance reporting, and risk management while demonstrating continued device conformity and benefit-risk acceptability.
Patient Guard acts as your regulatory consultancy partner, supporting the development, implementation, and maintenance of compliant PMS documentation aligned with IVDR and MDCG guidance.
Without an effective PMS system, manufacturers risk Notified Body non-conformities, regulatory delays, and increased scrutiny during IVDR certification.
Patient Guard provides expert PMS services tailored to your IVD classification, intended purpose, technology, and lifecycle stage.
New to the In Vitro Diagnostic Regulation (IVDR)?
This page explains Patient Guard’s Post-Market Surveillance (PMS) services for IVD manufacturers, helping organisations meet their ongoing obligations after placing devices on the European market. If you're looking for a broader introduction to the IVDR, including Performance Evaluation, Risk Management, Technical Documentation, Post-Market Surveillance, Post-Market Performance Follow-up (PMPF) and manufacturer responsibilities under Regulation (EU) 2017/746, read our IVDR for Beginners – A Comprehensive Guide.
Why Choose Patient Guard for IVDR PMS?
IVDR Class-Specific Expertise
We tailor your post-market frameworks precisely around your IVD’s classification (Class A to Class D), ensuring your documentation hits exact compliance thresholds without wasteful over-engineering.
Proactive Performance Monitoring
We design active surveillance systems that go beyond basic complaint tracking. We help you systematically capture real-world diagnostic performance, stability data, and scientific validity updates.
Total Technical File Continuity
Our regulatory specialists ensure your IVD post-market data feeds seamlessly back into your Performance Evaluation Reports (PER), Risk Management Files, and software lifecycle documentation.
What Our PMS Service Includes
IVD PMS Plans & Reports
We draft comprehensive Post-Market Surveillance Plans and compile final Post-Market Surveillance Reports (PMSR) demonstrating continuous control for lower-risk diagnostic devices.
IVD PSUR Authoring
For Class C and Class D diagnostics, we systematically author and update your Periodic Safety Update Reports (PSUR), keeping your risk-benefit documentation pristine for Notified Body review.
PMPF Strategy & Integration
We develop rigorous Post-Market Performance Follow-up (PMPF) plans and reports, establishing clear methodologies to gather continuous clinical and analytical data.
Vigilance & Trend Reporting
We establish compliant adverse event monitoring systems, creating precise protocols for fast, accurate incident reporting to European competent authorities and the MHRA.
Legacy File Gap Assessments
We audit your legacy IVDD performance files against modern EU IVDR Chapter VII mandates, mapping out targeted remediation actions to secure long-term market access.
Who Requires PMS Under IVDR?
- IVD manufacturers under IVDR
- Companies seeking CE marking for IVDs
- Manufacturers of Class A, B, C, and D IVDs
- Organisations undergoing Notified Body review
- Companies maintaining ongoing IVDR compliance
IVDR PMS Requirements
Under IVDR, manufacturers must:
- Establish and maintain a PMS system
- Develop a PMS Plan
- Collect and analyse post-market data
- Prepare PMS Reports or PSURs
- Identify trends and implement corrective actions where necessary
- Integrate PMS findings into Performance Evaluation and risk management
A compliant PMS system is essential for maintaining device safety, performance, and regulatory compliance.
Our Process
Step 1 – PMS Strategy & Planning
We assess your IVD classification, intended purpose, and regulatory obligations to develop a compliant PMS strategy and PMS Plan
Step 2 – Data Collection & Analysis
We establish PMS processes and evaluate complaints, vigilance reports, trend data, and real-world performance information
Step 3 - PMS Reporting & Lifecycle Compliance
We prepare PMS Reports or PSURs and align outputs with PMPF, Performance Evaluation, vigilance, and risk management documentation
Industries We Support
We support PMS services across:
- IVD manufacturers
- Biotechnology companies
- Diagnostic developers
- Laboratory technologies
- Start-ups and global healthcare companies
Cost of Service
IVDR Post Market Surveillance Services
ph
Ensure regulatory compliance and market readiness with expertly prepared PMS Plans, PMS Reports and PSURs.
Features
- IVDR-compliant PMS Plans, PMS Reports, and PSUR development tailored to your IVD classification
- Complaint handling, vigilance monitoring, and trend analysis support for ongoing compliance
- Integration of PMS outputs with PMPF, Performance Evaluation, and risk management documentation
- Ongoing lifecycle regulatory support aligned with IVDR and Notified Body expectations
Time Lines
Weeks 1–2 – PMS Strategy & Planning
Assess your IVD classification, intended purpose, and regulatory obligations to develop a compliant PMS Plan and lifecycle strategy
Weeks 3–6 – Data Collection & Trend Analysis
Establish PMS processes and analyse complaints, vigilance data, trend information, and post-market performance feedback
Weeks 7–10 – PMS Reporting & Lifecycle Compliance
Prepare PMS Reports or PSURs and align outputs with PMPF, Performance Evaluation, vigilance, and risk management documentation
Frequently Asked Questions (FAQs)
What is PMS under IVDR?
Post-Market Surveillance (PMS) is the ongoing process of collecting and analysing post-market information to ensure continued IVD safety and performance.
Is PMS mandatory under IVDR?
Yes, PMS is a mandatory requirement for all IVD manufacturers under IVDR.
What is the difference between a PMS Report and a PSUR?
PMS Reports are generally required for lower-risk IVDs, while PSURs are required for Class C and D devices.
How does PMS relate to PMPF?
PMS covers broader post-market monitoring activities, while PMPF specifically focuses on collecting post-market performance evidence.
How often should PMS documentation be updated?
Updates should be maintained regularly based on classification, risk profile, and post-market findings.
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