Training Features

IVDR Clinical Evidence and Performance Evaluation

Join us on 23 and 24 February 2026 to learn how to generate, assess, and document clinical evidence for IVDs in compliance with the EU IVDR.
Format

Virtual Training

Level

Basic

Date

23 and 24 February 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

Kristiane Schmidt

Certificate

Certificate included

Price

€ 1195 or equivalent currency

IVDR Clinical Evidence and Performance Evaluation Training

The In Vitro Diagnostic Regulation (IVDR) 2017/746 establishes strict requirements for clinical evidence and performance evaluation to ensure the safety, effectiveness, and quality of in vitro diagnostic (IVD) devices. Clinical evidence is fundamental to the conformity assessment process, demonstrating that an IVD device consistently performs as intended. Performance evaluation is a key activity that allows manufacturers to gather clinical evidence to support their device’s market approval and continued compliance with the IVDR throughout its lifecycle. 

Led by Kristiane Schmidt, this training guided professionals through the process of gathering and evaluating clinical evidence under the IVDR framework. The training covers how to plan the performance evaluation, generate and assess analytical and clinical data, and prepare regulatory documentation. 
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The In Vitro Diagnostic Regulation (IVDR) 2017/746 imposes stringent requirements for clinical evidence and performance evaluation to ensure the safety, performance, and quality of IVD devices on the European market. Clinical evidence plays a central role in the conformity assessment process, providing proof that an IVD device achieves its intended purpose and performs reliably throughout its lifecycle. Performance evaluation is essential for generating this evidence, requiring a structured approach to data collection and analysis.

This training offers a comprehensive overview of how to plan, generate, and assess clinical evidence in line with the IVDR. Participants will gain practical insights into the design and implementation of performance evaluation plans, the assessment of analytical and clinical data, and the preparation of key documentation such as PERs and CPSRs.
Key Learning Objectives
  • Understand the regulatory requirements for clinical evidence and performance evaluation under the IVDR 
  • Learn how to gather and evaluate clinical evidence for IVD devices
  • Develop and implement a Performance Evaluation Plan (PEP) 
  • Understand the relationship between scientific validity, analytical performance and clinical performance 
  • Address gaps in clinical evidence and generate robust data for regulatory submissions 
  • Prepare for Notified Body assessments and avoid common pitfalls in performance evaluation.
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 two sessions, lasting 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 23 and 24 February 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 13 and 14 April, 27 and 28 July, and 12 and 13 October 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals responsible for clinical evidence and performance evaluation 
  • Clinical Affairs and Clinical Research professionals involved in IVD clinical studies 
  • Quality Assurance (QA) professionals ensuring compliance with IVDR requirements 
  • IVD manufacturers seeking regulatory approval and maintaining compliance 
  • Anyone involved in clinical evidence generation, performance evaluation, and regulatory documentation 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 Evidence & Performance Evaluation
  • Understand the IVDR requirements for clinical evidence, including Articles 56–58 and Annex XIII, by exploring the key components, scientific validity, analytical performance, and clinical performance, and applying relevant guidance such as MDCG 2022-2 and CLSI documents.
  • Performance Evaluation Plan (PEP)
  • Develop and implement a performance evaluation plan by defining the device’s intended purpose, clinical benefits, State of the Art, and performance claims, while ensuring alignment with the IVDR General Safety and Performance Requirements.
  • Requirements for Clinical Evidence
  • Establish scientific validity and conduct systematic literature searches, analytical performance studies, and gather clinical data from performance studies, scientific literature, and other relevant sources to support IVDR compliance.
  • Clinical Performance Studies
  • Gain a comprehensive understanding of ISO 20916, including the planning, approval, conduct, and reporting of clinical performance studies, as well as the preparation of the Clinical Performance Study Report (CPSR) and Clinical Performance Report (CPR).
  • Documentation of clinical evidence and performance evaluation
  • Learn how to align clinical evidence and performance data with the device’s risk classification, understand the required documentation and their interconnections (PEP, PER, SVR, APR, CPSP, CPSR, CPR), and apply Post-Market Performance Follow-up (PMPF) to address risks identified during the performance evaluation.
  • Notified Body Expectations & Common Challenges
  • Gain insights into best practices for navigating the regulatory approval process, learn how to avoid common pitfalls in performance evaluation, and apply key lessons learned from Notified Body reviews of clinical evidence and performance data.

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  Clinical Evidence and Performance Evaluation for IVDR.

Expert-Led 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.