PMS Briefings #20: Effective PMS Management Reviews – How to Keep Your Surveillance System Fit and Compliant
As a manufacturer, you certainly know: A Post-Market Surveillance (PMS) system isn’t something you implement just once and then forget. To stay compliant with the Medical Device Regulation (MDR), your PMS system must continuously evolve and improve. A critical tool to ensure this is a regular PMS Management Review.
In this post, you’ll find out:
Why regular PMS management reviews are essential
How to effectively carry out these reviews
Typical pitfalls and practical solutions
1. Why Regular PMS Management Reviews Are Essential
MDR explicitly demands an active, effective, and regularly updated PMS system. A management review allows you to systematically evaluate your PMS system, identifying weaknesses and opportunities for improvement.
According to ISO 13485:2016 (section 5.6), management reviews must be carried out at regular intervals to guarantee the continuing suitability, adequacy, and effectiveness of your Quality Management System (QMS). Your PMS system, integrated within your QMS, requires this scrutiny as well.
In short: Without regular reviews, your PMS system will quickly lose its fitness for purpose and regulatory compliance.
2. How to Effectively Conduct a PMS Management Review
To ensure effectiveness, structure your PMS management reviews clearly and systematically. Below is a practical, step-by-step guide:
Step 1: Preparation and Scheduling
Plan your reviews regularly (at least annually; more frequently for higher-risk devices).
Ensure availability of key documents (e.g., PMS plans, PMS reports, trend analyses, and vigilance documentation).
Step 2: Multidisciplinary Participation
Involve representatives from quality management, regulatory affairs, clinical affairs, risk management, and senior management.
Ensure all participants understand the importance and objectives of the review.
Step 3: Structured Agenda and Documentation
A clear agenda is vital. Your management review should cover these key elements:
a) Review of PMS Activities and Data:
Incidents, vigilance, FSCA
Complaints and customer feedback
PMCF results and trend analyses
b) Assessment of Compliance Status:
Regulatory reporting deadlines and adherence (PSUR, MIR, FSCA)
Outcomes of internal and external audits
c) Effectiveness of PMS Processes:
Have objectives been met?
Suitability of tools, resources, and methodologies
Integration of PMS data into clinical evaluations and risk management
d) Review of Corrective and Preventive Actions (CAPA):
Status and effectiveness of PMS-related CAPAs
e) Improvement Proposals:
Concrete suggestions and recommendations for optimizing PMS processes
Step 4: Action Plan and Follow-up
Document your conclusions and decisions clearly.
Assign responsibilities for action items, define deadlines, and ensure systematic follow-up.
3. Typical Pitfalls and Practical Solutions
Many manufacturers stumble at similar hurdles. Here are typical issues and how you can effectively address them:
Practical Example: Turning Weaknesses into Strengths
A manufacturer identified through a PMS management review that complaint reporting was frequently delayed. Instead of facing a painful audit finding, proactive improvements (such as additional team training and automated reporting tools) were implemented early. During the next audit, this proactive approach earned the praise of auditors and avoided costly non-conformities.
Your takeaway: Regular PMS management reviews are not just regulatory burdens—they significantly strengthen your processes and prevent audit nightmares.
Regulatory Insight (ISO 13485:2016, Section 5.6):
"Top management shall review the organization's quality management system at planned intervals to ensure its continuing suitability, adequacy, and effectiveness."
Further Information:
ISO 13485:2016 (Medical Devices – Quality Management Systems)
Your Next Steps:
Evaluate your last PMS management review critically:
When was your last PMS management review?
Did it cover all essential points described above?
Are the action points clearly documented and followed up systematically?
Do you need support optimizing your PMS management review? Feel free to contact me directly for expert advice.
Stay compliant and informed!
Immanuel Bader