Training Features

IVDR Post-Market Activities: PMS, PMPF and Vigilance

Join us on 3 August 2026 for a focused virtual training that will help you master your post-market responsibilities under the EU IVDR.
Format

Virtual Training

Level

Intermediate

Date

3 August 2026

Time

14:00 - 18:00 CET

Duration

4 hours

Trainer

Kristiane Schmidt

Certificate

Certificate included

Price

€ 595 or equivalent currency

Post-Market Responsibilities under the EU IVDR

The In Vitro Diagnostic Regulation (IVDR) 2017/746 imposes stringent requirements on post-market activities, including Post-Market Surveillance (PMS), Post-Market Performance Follow-up (PMPF), and Vigilance. These activities are essential for ensuring ongoing compliance, maintaining device safety, and meeting regulatory expectations. 

Led by Kristiane Schmidt, this interactive training helps IVD manufacturers understand the regulatory framework and practical implementation of IVDR post-market activities. This course covers the key requirements, documentation needs, and best practices for establishing an effective PMS system. Participants will receive a certificate upon completion, confirming their understanding of IVDR post-market compliance.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The In Vitro Diagnostic Regulation 2017/746 sets strict expectations for post market activities, including surveillance, performance follow up, and vigilance. These obligations are critical for maintaining compliance, supporting device safety, and meeting regulatory requirements throughout the product lifecycle.

This virtual training gives IVD manufacturers clear guidance on the regulatory framework and the practical steps needed to implement effective post market processes. The course explains the core requirements, outlines necessary documentation, and shares best practices for building a robust PMS system. Participants receive a certificate upon completion that confirms their understanding of IVDR post market compliance.
Key Learning Objectives
  • Understand IVDR requirements for PMS, PMPF, and Vigilance
  • Learn how to develop and maintain a compliant PMS system
  • Gain knowledge of PMPF and its role in IVD device lifecycle management
  • Understand the regulatory obligations for vigilance and incident reporting
  • Learn how to compile and submit required reports (SSP, PMS Report, PSUR, PMSR, PMPF plans/reports)
  • Identify how PMS data integrates into risk management and continuous improvement
  • 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 sessions, lasting 4 hours, providing a focused and efficient learning experience. The sessions will take place on 3 August 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 2 March 2026. More information can be found on the registration page.
Who Should Attend?
  • Regulatory Affairs professionals responsible for PMS and Vigilance compliance
  • Quality Assurance (QA) managers and personnel
  • Post-Market Surveillance (PMS) and Vigilance professionals
  • Clinical and performance evaluation specialists
  • Risk management and safety officers
  • Anyone involved in maintaining IVDR post-market compliance within an IVD company.
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 post-market activities, including IVDR expectations for PMS, PMPF, vigilance, differences from IVDD, and interactions with authorities.
  • Post-market surveillance system design, covering PMS planning, data collection sources, and classification-based requirements
  • Post-market performance follow-up, including objectives, activity planning, differences from pre-market evaluation, and integration into the PMS system.
  • Vigilance and incident reporting, including requirements for serious incidents, FSCAs, reporting timelines, and interactions with authorities.
  • Summary and reporting obligations, including SSP and PSUR for higher-risk devices and post-market performance evaluation reports for lower-risk devices.
  • Risk management integration, using PMS and PMPF data to update risk files, support product improvement, and align with QMS requirements.
  • Best practices for implementation and compliance, addressing common challenges, preparing for audits, and strengthening PMS and PMPF processes.

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

Kristiane Schmidt

Kristiane is a senior consultant at Qserve Group with over 15 years of expertise in IVD product development, ISO & CE marking, risk management, and clinical trials, leveraging her strong technical background and passion for advancing medical technologies.