Technical Documentation and risk classification, according to IVDR (746/2017)

This is Part 2 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 compliance for IVD devices has become more rigorous. The implementation of a new rule-based risk classification makes a complete turn-around for IVD products. Going from the listing approach where the majority of the IVD medical devices have been self-declared by the manufacturer, the situation will now be the opposite. With the new classification only the lowest risk class A can be self-declared.

This means that the majority of the IVD´s, 80% or even more, need to be under notified body scrutiny where manufacturers must demonstrate compliance with IVDR. To obtain CE-certification, the technical documentation must provide evidence for the fulfillment of the general safety and performance requirements and undergo a conformity assessment by a notified body along with auditing of the manufacturer quality management system.

This course provides in-depth knowledge in the application of the new risk-based classification and how the risk class impacts on the CE-marking process. Through a structured exploration of the CE-marking process, participants will gain a clear understanding of the general safety and performance requirements and how to create and maintain the technical documentation to demonstrate compliance during the entire life cycle.

The course also addresses best practices for defining the intended purpose, determination of appropriate risk class and the notified body expectation on the technical documentation.

Course description

This half-day course provides a deeper understanding and practical overview of how to demonstrate compliance for in vitro diagnostic medical device (IVD) in accordance with the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, known as the IVDR.

The course explains the shift to the new rule-based risk classification of IVD´s and how it impacts on the conformity assessment for IVD´s. Participants will gain a clear understanding of the importance of the intended purpose and how to apply the classification rules to determine appropriate risk class. The course explores the general safety and performance requirements, the use of regulatory standards and how to create technical documentation to demonstrate compliance.

The course will also explain the structure and content of the technical documentation, and how to maintain the documentation during the entire lifetime.

Course outline

Tell the story – Structure and content of Technical Documentation
General Safety and Performance Requirements and the use of standards
Creation and maintenance of Technical Documentation
Conformity assessment and notified body scrutiny
Design changes and the impact on the technical documentation and maintenance of compliance.

Learning objectives

By the end of this course, participants will:

• Learn how to apply the classification rules to determine the risk class.
• Understand the impact of risk classification on the conformity assessment and the notified body scrutiny.
• Learn how to demonstrate compliance to general safety and performance requirements, by use of  standards (harmonized and non-harmonized) as well as other methods.
• Structure and content of the Technical Documentation, how it is created and maintained during the product life cycle to demonstrate safety and performance.
• Understand how product design changes influence the Technical Documentation.

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 involved in product development, preparing or reviewing technical documentation.

Examples of who should attend:

• Regulatory Affairs professionals
• Quality Assurance and Compliance specialists
• R&D and Product Development teams
• 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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