IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF

This is Part 3 of 3 in our IVDR training series (Click the titles below for information)

1. Introduction to IVDR (746/2017) and CE-marking of In-Vitro Diagnostic devices
   – Nov 18, 2025
2. Technical Documentation and risk classification, according to IVDR (746/2017)
   – Nov 27, 2025
3. IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF
   – Dec 9, 2025

Bundle price for all 3 parts: 1250 Euro (Save 175 Euro)  Order the bundle here →
Note. All parts are stand-alone, and you can attend one or more of them.

With the implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, demonstrating the performance and safety of IVD devices has become more rigorous, evidence-driven, and central to achieving regulatory compliance. This course is designed to guide manufacturers, regulatory professionals, and quality assurance teams through the key requirements for performance evaluation under the IVDR.

Through a structured exploration of scientific validity, analytical performance, and clinical performance, participants will gain a clear understanding of how to generate, document, and present robust evidence to support the safety and intended purpose of their IVD devices. The course also addresses best practices for performance studies, risk management integration, and alignment with notified body expectations.

Whether you are preparing a Performance Evaluation Report (PER) for a legacy device or developing documentation for a new submission, this course equips you with the practical tools and regulatory insight needed to navigate IVDR requirements with confidence

Course description

This half-day course provides a focused and practical overview of how to demonstrate performance and safety for in vitro diagnostic (IVD) devices in accordance with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.

Participants will gain a clear understanding of the core components of performance evaluation, scientific validity, analytical performance, and clinical performance and how these must be supported through appropriate evidence and documentation. The course also covers the structure and expectations for the Performance Evaluation Plan (PEP) and the Performance Evaluation Report (PER), how to align with notified body expectations, and common pitfalls to avoid.

Course outline

• Importance of Performance Evaluation in conformity assessment
• Components and strategy of the Performance Evaluation
• Structure and content of the PEP and PER
• Integration with technical documentation
• Addressing gaps in data and handling legacy devices
• Aligning performance data with claims
• Using risk management data (ISO 14971) in support of performance
• Principles of Post Market Surveillance and Post market Clinical Follow-up
• Common safety issues flagged by notified bodies
• Notified body expectations and common findings

Learning objectives

By the end of this course, participants will be able to:

1. Understand the regulatory framework for performance evaluation under the IVDR and how it differs from the IVDD.
2. Identify and describe the three key components of performance evaluation: scientific validity, analytical performance, and clinical performance.
3. Evaluate the types of evidence required to demonstrate each component of performance in compliance with IVDR expectations.
4. Develop and structure a Performance Evaluation Report (PER) that meets the IVDR requirements and supports device safety and intended purpose.
5. Recognize the relationship between performance evaluation and risk management, and how to integrate both effectively in technical documentation.
6. Recognize the difference between performance evaluation and performance study, including how to perform each activity
7. Anticipate and address common regulatory challenges, including notified body feedback and legacy device documentation gaps.
8. Apply practical strategies for collecting, analyzing, and presenting performance data that align with IVDR standards and facilitate smoother regulatory reviews.

Who should attend

This course is ideal for professionals involved in the development, regulatory compliance, and quality assurance of IVD devices under the EU IVDR. It is especially valuable for those responsible for preparing or reviewing performance evaluation documentation.

Examples of who should attend:

• Regulatory Affairs professionals
• Quality Assurance and Compliance specialists
• Clinical Affairs and Medical Affairs personnel
• R&D and Product Development teams
• Technical Writers and Documentation Specialists
• Project Managers involved in IVD submissions
• Manufacturers transitioning legacy IVDs to IVDR compliance

No prior expert knowledge of the IVDR is required, but a basic understanding of IVD development or regulatory frameworks will help participants get the most out of the course.

Prerequisites

To benefit from the training it is recommended that you have basic knowledge of IVD medical devices or medical devices and the regulations e.g. basic IVDR training courses,  from the previous IVD directive (IVDD), the medical device regulation or directive (MDR or MDD). Alternatively, experience of analytical devices and methods in related research areas.

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