Introduction to IVDR (746/2017) and CE-marking of In-Vitro Diagnostic devices

This is Part 1 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.

Do you know that the word “safety” is mentioned 238 times in IVDR, and the word “performance” even 745 times?
– Yes, it is true! Safety and performance are what IVDR is about.

But what does it mean, and how do you reach it?  Join our new IVDR course and learn the fundamentals of IVDR to stay ready for the challenges.

A key aspect is whether an analytical device such as kit, reagent, tests, instruments or software is an In Vitro Diagnostic medical device (IVD) which must comply with the EU regulation on In Vitro Diagnostic medical device (EU 2017/746). Sometimes it is obvious, sometimes not, and you have to find out if it is an IVD, a product for research use, laboratory equipment or just a method. Once it becomes clear that it is an IVD you are likely to struggle with understanding the obligations under IVDR and how to meet the expected level of safety and performance required for CE-marking.

This course is designed to guide you in the qualification of IVD´s and to take you through the fundamentals of IVDR, giving a deeper understanding of how to navigate the regulatory landscape to meet the requirements for CE-marking under IVDR.

Course description

This half-day course provides a comprehensive understanding of the EU Regulation 2017/746 on In Vitro Diagnostic medical devices (IVDR) and the CE certification of In Vitro Diagnostic medical devices (IVD). The course covers the key elements of the regulation, ensuring that attendees gain the knowledge necessary to navigate the regulatory landscape effectively and achieve compliance.

The course explains the fundamentals of IVDR and how to apply risk management, performance evaluation and post market surveillance in a life-cycle approach. Among other topics, the course also explains the importance of the intended purpose, the new risk classification of IVD´s and why a quality management system is required to serve the creation of the technical documentation and maintain the safety and performance.

Course outline

• Overview of the IVDR and key changes from IVDD
• Roles and obligations under IVDR
• Key elements of the IVDR
• Understand the differences between IVD´s – Accessories – RUO
• The role and importance of a well-defined Intended purpose
• The new risk classification of IVD´s and how it impacts the way ahead
• Overview of Technical Documentation
• Notified Body certification process for class B, C and D devices and self-declaration of class A devices.

Learning objectives

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

• Navigate within the regulatory landscape and understand how a regulatory strategy helps to tackle the challenges.
• Recognize what makes a product an IVD and define whether it is a kit, instrument, software, system or an accessory.
• Know about the fundamentals of the IVDR and the life-cycle approach to maintain safety and performance.
• Understanding the key elements of the intended purpose and why it plays such an important role for the qualification and risk classification of IVD´s.
• Recognize the General Safety and Performance Requirements and the key element of the Technical Documentation.
• Know the key aspects of the Quality Management System and why it is required.

Who should attend

This course is aimed for professionals working within the IVD industry or related research where products or technologies is to be transferred into diagnostics. You are typically involved in product design & development, production, regulatory and quality management tasks or in business development, preferably in start-up companies or small to mid-size companies.

Examples of who should attend:

• Managers in the IVD industry e.g. CEO, CTO, COO
• Product managers
• Product development managers and engineer
• Other employees in the IVD industry e.g. production staff, service staff
• Quality Assurance managers or specialists
• Regulatory affairs managers or specialists
• QA/RA Directors
• Risk management manager
• Researchers and clinicians in IVD related research
• Distributor of IVD´s

Prerequisites

To benefit from the training it is recommended that you have some knowledge of IVD medical devices or medical devices and the regulations e.g.  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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