Training Features

Post-Market Surveillance, Vigilance & PMCF for Medical Devices Under the EU MDR

Gain practical skills to implement PMS, Vigilance, and PMCF under MDR and ensure continuous compliance and patient safety.
Format

Virtual Training

Level

Basic/Advanced

Date

27 July 2026

Time

14:00 - 18:00 CET

Duration

4 hours

Trainer

Jorn van Binsbergen

Certificate

Certificate included

Price

€ 595 or equivalent currency

Post-Market Surveillance, Vigilance, and PMCF Under EU MDR

Under the Medical Device Regulation (MDR) 2017/745, manufacturers must establish a proactive and systematic approach to Post-Market Surveillance (PMS), including Vigilance and Post-Market Clinical Follow-up (PMCF). These requirements ensure continuous monitoring of device safety and performance, providing updated clinical evidence throughout the product lifecycle. 

Led by Jorn van Binsbergen, this interactive training helps medical device manufacturers understand and implement PMS, Vigilance, and PMCF in compliance with MDR. This course provides practical insights into regulatory requirements, data collection strategies, and best practices for ensuring compliance and readiness for Notified Body reviews. Participants will receive a certificate upon completion, confirming their understanding of PMS obligations under MDR. 

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
This training equips medical device professionals with the knowledge and tools to implement PMS, Vigilance, and PMCF effectively. Participants will learn how to collect and analyze post-market data, integrate findings into Clinical Evaluation and Risk Management, and apply best practices for compliance with MDR. The course also provides guidance on preparing for Notified Body inspections and regulatory reviews. Upon completion, attendees receive a certificate confirming their competence in managing PMS obligations under MDR.
Key Learning Objectives
  • Understand PMS, Vigilance, and PMCF requirements under EU MDR 
  • Learn how to develop and implement a PMS system compliant with MDR
  • Gain knowledge of vigilance reporting obligations and incident classification 
  • Understand how to design and execute PMCF activities to generate clinical data 
  • Learn how to compile and maintain required reports (PSUR, PMSR, PMCF Plan/Report) 
  • Identify how PMS data integrates with risk management and clinical evaluation 
  • Recognize common challenges in post-market activities and best practices for compliance 
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one session, lasting 4 hours, providing a focused and efficient learning experience. The sessions will take place on 27 July 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 19 February, 9 April, and 9 October 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals responsible for PMS and vigilance compliance. 
  • Quality Assurance (QA) managers and personnel. 
  • Clinical Affairs and Clinical Research professionals involved in PMCF. 
  • Post-Market Surveillance (PMS) and Risk Management specialists. 
  • Medical device manufacturers seeking compliance with MDR post-market requirements. 
  • Anyone involved in maintaining post-market compliance and regulatory documentation. 
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework for PMS, Vigilance, and PMCF: Overview of PMS requirements under MDR (Articles 83–86), the connection between PMS, PMCF, Risk Management, and Clinical Evaluation, and the role of Vigilance and PMCF in ongoing compliance. 
  • Establishing an Effective PMS System: Developing and implementing a PMS plan, identifying data sources (complaints, literature, user feedback, registries), and aligning PMS with QMS requirements. 
  • Vigilance & Incident Reporting Under MDR: Definitions of serious incidents and Field Safety Corrective Actions (FSCA), reporting timelines and obligations to Competent Authorities and Notified Bodies, and conducting trend reporting with risk-based monitoring. 
  • Post-Market Clinical Follow-up (PMCF) Requirements: Role of PMCF in Clinical Evaluation and lifecycle management, types of PMCF activities (surveys, observational studies, registries), and criteria for when PMCF studies are required and how to design them. 
  • Periodic Reporting & Documentation:– Preparation of Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices, Post-Market Surveillance Reports (PMSR) for Class I devices, and integration of post-market data into Clinical Evaluation Reports (CER). 
  • Risk Management & Continuous Compliance: Using PMS and PMCF data to update risk management files, aligning PMS activities with ISO 14971 principles, and preparing for Notified Body audits and regulatory inspections. 
  • Common Challenges & Best Practices: Lessons learned from audits and regulatory findings, practical approaches to PMS implementation, and strategies to maintain compliance while minimizing regulatory burden.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Jorn van Binsbergen

Jorn van Binsbergen is a clinical writer at Qserve Group, based in the Netherlands, contributing his expertise in clinical evaluations, regulatory affairs, and scientific writing to support the development and post-market assessment of medical devices.