Training Features

IVDR Clinical Performance Studies and ISO 20916 Requirements

Join our training on IVDR Clinical Performance Studies and ISO 20916 Requirements on 9 July 2026 to gain a clear understanding of how to design, conduct, and document clinical performance studies in compliance with the EU IVDR and ISO 20916 standards.
Format

Virtual Training

Level

Intermediate

Date

9 July 2026

Time

14:00 - 18:00 CET

Duration

4 hours

Trainer

Kristiane Schmidt

Certificate

Certificate included

Price

€ 595 or equivalent currency

IVDR Clinical Performance Studies and ISO 20916 Requirements

Under the In Vitro Diagnostic Regulation (IVDR) 2017/746, clinical performance studies are crucial to demonstrate the safety and performance of in vitro diagnostic (IVD) devices. ISO 20916 provides the Good Clinical Study Practice (GCP) for conducting clinical performance studies in compliance with regulatory requirements. Manufacturers must ensure that their studies align with IVDR requirements and provide robust clinical evidence to support market approval and ongoing compliance. 

Led by Kristiane Schmidt, this training helps professionals understand the regulatory framework for clinical performance studies, the application of ISO 20916, and the practical implementation of study design, execution, and reporting. Participants will receive a certificate upon completion, confirming their understanding of ISO 20916 and IVDR clinical performance study requirements.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The implementation of the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has significantly transformed the regulatory landscape for IVD devices in Europe, placing greater emphasis on clinical evidence and performance evaluation. Clinical performance studies now play a vital role in demonstrating the safety, scientific validity, and clinical performance of IVD devices. This training provides a comprehensive overview of the key requirements for conducting these studies in alignment with the IVDR and the updated EN ISO 20916:2024 standard.

This training provides professionals with a clear understanding of the regulatory framework for clinical performance studies under the IVDR, the application of ISO 20916, and the practical aspects of study design, conduct, and reporting. Upon successful completion, participants will receive a certificate demonstrating their knowledge of ISO 20916 and the clinical performance study requirements of the IVDR.
Key Learning Objectives
  • Understand IVDR requirements for clinical performance studies and collection of clinical evidence 
  • Learn how to apply ISO 20916 principles in IVD performance studies 
  • Gain insights into study design, execution, and regulatory submission processes 
  • Learn how to ensure ethical compliance, data integrity, and subject protection 
  • Understand the process for ethical committee review study authorization by competent authorities 
  • Identify best practices for planning, conduct and reporting of clinical performance studies.
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 9 July 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If the July training date is not suitable, an additional session will be held on 2 February 2026. More information.
Who Should Attend?
  • Regulatory Affairs professionals responsible for clinical performance evaluations 
  • Clinical Affairs and Clinical Research professionals conducting IVD studies 
  • Quality Assurance (QA) professionals ensuring compliance with ISO 20916 
  • IVD manufacturers seeking IVDR compliance for clinical performance studies 
  • Anyone involved in generating and maintaining clinical evidence for IVD devices 
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 Clinical Performance Studie
  • Understand the IVDR requirements for clinical evidence and performance studies (Articles 56–58), including interventional studies and those involving additional risk (Articles 58 and 70), and gain a comprehensive overview of ISO 20916: Good Study Practice for IVD clinical performance studies.
  • Clinical Performance Study Design & Planning
  • Learn how to design and implement a clinical performance study, including protocol development, risk determination, statistical planning, data management, and navigating regulatory approvals from Ethics Committees and Competent Authorities. 
  • ISO 20916: Good Clinical Study Practice (GCP)
  • Gain insight into the key principles of ISO 20916 for IVD clinical investigations, including ethical considerations and informed consent, sponsor and investigator responsibilities, and best practices for study site qualification, initiation, and monitoring.
  • Clinical Performance Study Conduct & Reporting
  • Learn best practices for managing clinical performance studies, including data collection, recording and reporting device deficiencies and adverse events, and preparing study results for regulatory submissions and conformity assessments.

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 conducting clinical performance studies and ensuring compliance with the EU IVDR and ISO 20916 requirements.

Expert-Led IVDR Training for Practical Compliance

Meet the Trainer

Kristiane Schmidt

Kristiane is a Senior Consultant at Qserve with over 15 years of experience in IVD product development, specializing in ISO 13485, CE marking, and performance evaluation, with a strong technical background in qPCR, immunoassays, and point-of-care devices.